SEMESTERVIII

BP801T.BIOSTATISITCSANDRESEARCHMETHODOLOGY(Theory)

45Hours

Scope: To understand the applications of Biostatics in Pharmacy. This subject deals withdescriptive statistics,Graphics, Correlation,Regression, logistic regression Probabilitytheory,Samplingtechnique,Parametrictests,NonParametrictests,ANOVA,Introd uction to Design of Experiments, Phases of Clinical trials and Observational andExperimentalstudies,SPSS,RandMINITABstatisticalsoftware’s,analyzingthestatistical datausingExcel.

Objectives:Upon completionofthecoursethestudentshallbeableto

• KnowtheoperationofM.S.Excel,SPSS,RandMINITAB®, DoE(DesignofExperiment)

• Knowthevariousstatisticaltechniquestosolvestatisticalproblems

• Appreciatestatisticaltechniquesinsolvingtheproblems.

Coursecontent:

Unit-I 10Hours

Introduction:Statistics,Biostatistics,Frequencydistribution

Measures of central tendency:Mean, Median, Mode- Pharmaceutical examplesMeasures of dispersion: Dispersion, Range, standard deviation,Pharmaceuticalproblems

Correlation: Definition, Karl Pearson’s coefficient of correlation, Multiple correlation - Pharmaceuticalsexamples

Unit-II 10Hours

Regression: Curve fittingbythe methodof leastsquares, fittingthelines y=a+bxandx

=a+by,Multipleregression,standarderrorofregression– PharmaceuticalExamplesProbability:Definition of probability, Binomial distribution, Normal distribution,Poisson’sdistribution,properties -problems Sample,Population,largesample,smallsample, Nullhypothesis,alternativehypothesis,sampling, essence of sampling, types of sampling, Error-I type,Error-II type, Standarderrorofmean(SEM)-Pharmaceutical examples Parametric test: t-test(Sample, Pooled or Unpaired and Paired) , ANOVA, (One wayandTwoway),Least Significancedifference

Unit-III 10Hours

Non Parametric tests: Wilcoxon Rank Sum Test, Mann-Whitney U test, Kruskal- Wallistest,FriedmanTest

Introduction to Research: Need for research, Need for design of Experiments,ExperientialDesign Technique,plagiarism

Graphs: Histogram, Pie Chart, Cubic Graph, response surface plot, Counter Plot graphDesigningthemethodology:SamplesizedeterminationandPowerofastudy,Reportw ritingandpresentationofdata,Protocol,Cohorts studies, Observational studies,Experimental studies,Designingclinical trial,various phases.

Unit-IV 8Hours

Blockingandconfoundingsystem forTwo-level factorials

Regression modeling: Hypothesis testing in Simple and Multiple regressionmodelsIntroductiontoPracticalcomponentsofIndustrialandClinicalTrialsPr oblems:StatisticalAnalysisUsingExcel,SPSS,MINITAB®,DESIGNOFEXPERIMENTS,R- OnlineStatisticalSoftware’stoIndustrialandClinical trialapproach

Unit-V 7Hours

Design andAnalysisofexperiments:

Factorial Design: Definition, 22, 23design. Advantage of factorial designResponseSurfacemethodology:Centralcompositedesign,Historicaldesign, OptimizationTechniques

RecommendedBooks(Latestedition):

1. Pharmaceuticalstatistics- Practicalandclinicalapplications,SanfordBolton,publisherMarcel DekkerInc.NewYork.

2. FundamentalofStatistics –HimalayaPublishingHouse-S.C.Guptha

3. DesignandAnalysisofExperiments–PHI LearningPrivateLimited,

   R.Pannerselvam,

4. Design and AnalysisofExperiments– WileyStudentsEdition,DouglasandC.Montgomery

Scope:

BP802TSOCIALAND PREVENTIVEPHARMACY (Theory)

Hours:45

The purpose of this course is to introduce to students a number of health issues and theirchallenges. This course also introduced a number of national health programmes. Therolesofthe pharmacistinthesecontextsarealso discussed.

Objectives:

Afterthesuccessfulcompletionofthiscourse,thestudentshallbeableto:

• Acquirehighconsciousness/realizationofcurrentissuesrelatedtohealthandpharmace uticalproblemswithinthe countryandworldwide.

• Have a critical wayofthinkingbasedon current healthcaredevelopment.

• Evaluate alternative ways of solving problems related tohealth andpharmaceuticalissues

Coursecontent:

UnitI: 10Hours

Concept of health and disease: Definition, concepts and evaluation of public health.Understanding the concept of prevention and control of disease, social causes of diseasesandsocial problems of thesick.

Social and health education: Food in relation to nutrition and health, Balanced diet,Nutritionaldeficiencies,Vitamindeficiencies,Malnutrition anditsprevention.

Sociology and health: Socio cultural factors related to health and disease, Impact ofurbanization onhealth anddisease, Povertyand health

Hygieneandhealth:personalhygieneandhealthcare; avoidablehabits

UnitII: 10Hours

Preventive medicine: General principles of prevention and control of diseases such ascholera,SARS,Ebolavirus,influenza,acuterespiratory infections,malaria,chickenguinea, dengue, lymphatic filariasis, pneumonia, hypertension, diabetes mellitus, cancer,drugaddiction-drugsubstanceabuse

UnitIII: 10Hours

National health programs, its objectives, functioning and outcome of the following:HIVANDAIDScontrolprogramme,TB,Integrateddiseasesurveillanceprogram(I DSP),Nationalleprosycontrolprogramme,Nationalmentalhealthprogram,National

programme for prevention and control of deafness, Universal immunization programme,Nationalprogrammeforcontrolofblindness,Pulsepolioprogramme.

UnitIV: 08Hours

National health intervention programme for mother and child, National family welfareprogramme, National tobacco control programme, National Malaria Prevention Program,National programme for the health care for the elderly, Social health programme; role ofWHOinIndian nationalprogram

UnitV: 07Hours

Community services in rural, urban and school health: Functions of PHC,Improvementin rural sanitation, national urban health mission, Health promotion and education inschool.

RecommendedBooks(Latestedition):

1. Short Textbook of Preventive and Social Medicine, Prabhakara GN, 2nd Edition,2010,ISBN: 9789380704104, JAYPEEPublications

2. Textbook of Preventive and Social Medicine (Mahajan and Gupta), Edited by RoyRabindra Nath, Saha Indranil, 4thEdition, 2013, ISBN: 9789350901878, JAYPEEPublications

3. Review of Preventive and Social Medicine (Including Biostatistics), Jain Vivek, 6thEdition,2014,ISBN: 9789351522331, JAYPEEPublications

4. EssentialsofCommunity Medicine—

   APracticalApproach,HiremathLalitaD,HiremathDhananjayaA,2ndEdition,2012,ISBN

   :9789350250440,JAYPEEPublications

5. ParkTextbook ofPreventiveandSocialMedicine,KPark,21stEdition,2011,ISBN- 14:9788190128285,BANARSIDASBHANOTPUBLISHERS.

6. CommunityPharmacyPractice,RameshAdepu,BSPpublishers, Hyderabad

Recommended Journals:

1. ResearchinSocialandAdministrativePharmacy,Elsevier,Ireland

BP803ET. Pharmaceutical Marketing Management (Theory)

45Hours

Scope:

The pharmaceutical industry not only needs highly qualified researchers, chemists and,technicalpeople, butalsorequires skilled managers who cantake the industry forwardby managing and taking the complex decisions which are imperative for the growth of theindustry. The KnowledgeandKnow-how ofmarketing managementgroomthe peoplefortakingachallenging rolein Sales and Productmanagement.

Course Objective: The course aims to provide an understanding of marketing conceptsandtechniques andtheirapplicationsinthepharmaceuticalindustry.

UnitI 10Hours

Marketing:

Definition, general concepts and scope of marketing; Distinction between marketing &selling; Marketing environment; Industry and competitive analysis; Analyzing consumerbuyingbehavior; industrial buyingbehavior.

Pharmaceuticalmarket:

Quantitative and qualitative aspects; size and composition of the market; demographicdescriptionsandsocio- psychologicalcharacteristicsoftheconsumer;marketsegmentation&targeting.Consumerprofi le;Motivationandprescribinghabitsofthephysician;patients' choice of physicianand retailpharmacist.Analyzing the Market;Roleofmarket research.

UnitII 10Hours

Productdecision:

Classification, product line and product mix decisions, product lifecycle,productportfolioanalysis;productpositioning;New productdecisions;Productbranding,packagingandlabelingdecisions,Productmanagementinp harmaceuticalindustry.

UnitIII 10Hours

Promotion:

Methods,determinantsofpromotionalmix,promotionalbudget;Anoverviewofpersonalselling

,advertising,directmail,journals,sampling,retailing, medicalexhibition,publicrelations,onlinepromotionaltechniques forOTCProducts.

160

UnitIV 10Hours

Pharmaceuticalmarketingchannels: Designingchannel,channelmembers,selectingtheappropriatechannel,conflictinchannels,phy sicaldistributionmanagement:Strategicimportance,tasksinphysicaldistributionmanagement.

Professionalsalesrepresentative(PSR): DutiesofPSR,purposeofdetailing,selectionandtraining,supervising,normsforcustomercalls, motivating,evaluating,compensationandfutureprospectsofthePSR.

UnitV 10Hours

Pricing:

Meaning, importance, objectives, determinants of price; pricing methods and strategies,issuesinpricemanagementinpharmaceuticalindustry.AnoverviewofDPCO(DrugP riceControlOrder)andNPPA(NationalPharmaceuticalPricingAuthority).

Emergingconceptsinmarketing:

Vertical & Horizontal Marketing; RuralMarketing; Consumerism; Industrial Marketing;GlobalMarketing.

Recommended Books:(LatestEditions)

1. PhilipKotlerandKevinLaneKeller:MarketingManagement,PrenticeHallofIndia,NewDel hi

2. Walker,BoydandLarreche:MarketingStrategy-PlanningandImplementation,TataMC GrawHill,NewDelhi.

3. DhruvGrewalandMichaelLevy:Marketing,TataMCGrawHill

4. ArunKumarandNMenakshi:MarketingManagement,VikasPublishing,India

5. RajanSaxena:MarketingManagement; TataMC Graw-Hill(IndiaEdition)

6. Ramaswamy,U.S&Nanakamari,S:MarketingManagemnt:GlobalPerspective,IndianCon text,MacmilanIndia,NewDelhi.

7. Shanker,Ravi:ServiceMarketing,ExcellBooks,NewDelhi

8. SubbaRaoChanganti,PharmaceuticalMarketinginIndia(GIFT– Excelseries)ExcelPublications.

   
   

   161

   BP804ET:PHARMACEUTICALREGULATORYSCIENCE(Theory)

   
   

   45Hours

   
   

   Scope: This course is designed to impart the fundamental knowledge on the regulatoryrequirementsforapprovalofnewdrugs, anddrugproductsinregulatedmarkets ofIndia & other countries like US, EU,Japan,Australia,UK etc.Itpreparesthestudentstolearnindetailonthe regulatoryrequirements,documentationrequirements,andregistrationprocedures formarketingthedrugproducts.

   
   

   Objectives:Upon completionofthesubjectstudentshallbeableto;

   1. Know about the processof drugdiscoveryanddevelopment

   2. Knowtheregulatoryauthoritiesandagenciesgoverningthemanufactureandsaleofpha rmaceuticals

   3. KnowtheregulatoryapprovalprocessandtheirregistrationinIndianandintern ationalmarkets

Coursecontent:

UnitI 10Hours

NewDrugDiscoveryanddevelopment

Stages of drug discovery, Drug development process, pre-clinical studies, non- clinicalactivities, clinical studies,Innovator andgenerics, Concept of generics, Generic drugproductdevelopment.

UnitII 10Hours

RegulatoryApprovalProcess

Approvalprocessesandtimelines involved inInvestigationalNew Drug (IND),NewDrug Application (NDA), Abbreviated New Drug Application (ANDA). Changes to anapprovedNDA/ ANDA.

Regulatoryauthorities andagencies

Overview of regulatory authorities of India, United States, European Union,Australia,Japan,Canada(Organizationstructureand typesofapplications)

UnitIII 10Hours

RegistrationofIndiandrugproductinoverseas market

Procedure for export of pharmaceutical products, Technical documentation, Drug MasterFiles(DMF),CommonTechnicalDocument(CTD),electronicCommonTechnical

162

Document(eCTD),ASEANCommonTechnicalDocument(ACTD)research.

UnitIV 08Hours

Clinicaltrials

Developingclinicaltrialprotocols,InstitutionalReviewBoard/IndependentEthicscommittee- formationandworkingprocedures,Informedconsentprocessandprocedures,GCPobligationso fInvestigators,sponsors&Monitors,Managing andMonitoringclinical trials,Pharmacovigilance-safetymonitoringinclinical trials

UnitV 07Hours

RegulatoryConcepts

Basicterminology,guidance,guidelines,regulations,LawsandActs,Orangebook,FederalReg ister,CodeofFederalRegulatory, Purplebook

Recommended books(Latestedition):

1. DrugRegulatoryAffairsbySachinItkar,Dr.N.S.Vyawahare,Nirali Prakashan.

2. The Pharmaceutical Regulatory Process, Second Edition Edited by Ira R. Berry andRobertP. Martin, Drugs and the Pharmaceutical Sciences,Vol.185. Informa HealthcarePublishers.

3. NewDrugApprovalProcess:AcceleratingGlobalRegistrationsByRichardAGuar ino,MD,5thedition,DrugsandthePharmaceuticalSciences,Vol.190.

4. Guidebookfordrugregulatorysubmissions/SandyWeinberg.ByJohnWiley&Sons.I nc.

5. FDARegulatoryAffairs:aguideforprescriptiondrugs,medicaldevices,andbiolo gics/edited byDouglas J. Pisano,David Mantus.

6. GenericDrugProductDevelopment,SolidOralDosageforms,LeonShargelandIsader Kaufer,Marcel Dekkerseries,Vol.143

7. ClinicalTrialsandHumanResearch:APracticalGuidetoRegulatoryComplianceByFay A.RozovskyandRodneyK.Adams

8. PrinciplesandPracticesof ClinicalResearch, SecondEditionEditedby JohnI.GallinandFrederick P.Ognibene

9. Drugs:FromDiscoveryto Approval,SecondEditionByRickNg

   
   

   163

   BP805T:PHARMACOVIGILANCE(Theory)

   45hours

   
   

   Scope: This paper will provide an opportunity for the student to learn about development ofpharmacovigilanceasa science, basic terminologies used inpharmacovigilance, globalscenarioofPharmacovigilance,trainstudentsonestablishingpharmacovigilanceprogrammeinan organization, various methods that can be used to generate safety data and signal detection. Thispaperalsodevelopstheskillsof classifyingdrugs,diseasesandadversedrugreactions.

   
   

   Objectives:

   
   

   At completion of this paper it is expected that students will be able to (know, do, andappreciate):

   1. Whydrugsafetymonitoringisimportant?

   2. Historyanddevelopmentofpharmacovigilance

   3. Nationalandinternationalscenarioofpharmacovigilance

   4. Dictionaries,codingandterminologiesusedinpharmacovigilance

   5. Detectionofnewadversedrugreactionsandtheirassessment

   6. Internationalstandardsforclassificationofdiseasesanddrugs

   7. Adversedrugreactionreportingsystemsandcommunicationinpharmacovigilance

   8. Methodstogeneratesafetydataduringpreclinical,clinicalandpostapprovalphasesofdrugs’ life cycle

   9. Drugsafetyevaluationinpaediatrics,geriatrics,pregnancyandlactation

   10. PharmacovigilanceProgramofIndia(PvPI)requirement for ADRreportinginIndia

   11. ICHguidelinesforICSR,PSUR,expeditedreporting,pharmacovigilanceplanning

   12. CIOMSrequirementsforADRreporting

   13. Writingcasenarrativesofadverseeventsandtheirquality.

       
       

       CourseContent

       
       

       UnitI 10Hours

       IntroductiontoPharmacovigilance

       • HistoryanddevelopmentofPharmacovigilance

       • ImportanceofsafetymonitoringofMedicine

       • WHOinternationaldrugmonitoringprogramme

       • PharmacovigilanceProgramofIndia(PvPI)

         Introductiontoadversedrugreactions

       • DefinitionsandclassificationofADRs

       • Detectionandreporting

       • MethodsinCausalityassessment

       • Severityandseriousnessassessment

       • Predictabilityandpreventabilityassessment

       • Managementofadversedrugreactions

         Basicterminologiesusedinpharmacovigilance

         
         

         164

       • Terminologiesofadversemedicationrelatedevents

       • Regulatoryterminologies

         Unit II 10hours

         Druganddiseaseclassification

       • Anatomical,therapeuticandchemicalclassificationofdrugs

       • Internationalclassificationofdiseases

       • Dailydefineddoses

       • InternationalNonproprietaryNamesfordrugs

         Drugdictionariesandcodinginpharmacovigilance

       • WHOadversereactionterminologies

       • MedDRAandStandardisedMedDRAqueries

       • WHOdrugdictionary

       • Eudravigilancemedicinalproductdictionary

         Informationresourcesinpharmacovigilance

       • Basicdruginformationresources

       • SpecialisedresourcesforADRs

         Establishingpharmacovigilanceprogramme

       • Establishinginahospital

       • Establishment &operationofdrugsafetydepartment inindustry

       • ContractResearchOrganisations(CROs)

       • Establishinganationalprogramme

         
         

         Unit III 10Hours

         Vaccinesafetysurveillance

       • VaccinePharmacovigilance

       • Vaccinationfailure

       • Adverseeventsfollowingimmunization

         Pharmacovigilancemethods

       • Passivesurveillance–Spontaneousreportsandcaseseries

       • Stimulatedreporting

       • Activesurveillance–Sentinelsites,drugeventmonitoringandregistries

       • Comparativeobservationalstudies– Crosssectionalstudy,casecontrolstudyandcohort study

       • Targetedclinicalinvestigations

         Communicationinpharmacovigilance

       • EffectivecommunicationinPharmacovigilance

       • CommunicationinDrugSafetyCrisismanagement

       • CommunicatingwithRegulatoryAgencies,BusinessPartners,Healthcarefacilities&Me dia

         
         

         165

         UnitIV 8Hours

         
         

         Safetydatageneration

       • Preclinicalphase

       • Clinicalphase

       • Postapprovalphase(PMS)

         ICHGuidelinesforPharmacovigilance

       • OrganizationandobjectivesofICH

       • Expeditedreporting

       • Individualcasesafetyreports

       • Periodicsafetyupdatereports

       • Postapprovalexpeditedreporting

       • Pharmacovigilanceplanning

       • Goodclinicalpracticeinpharmacovigilancestudies

         
         

         UnitV 7hours

         Pharmacogenomicsofadversedrugreactions

       • GeneticsrelatedADRwithexamplefocusingPKparameters.

         Drugsafetyevaluationinspecialpopulation

       • Paediatrics

       • Pregnancyandlactation

       • Geriatrics

         CIOMS

       • CIOMSWorkingGroups

       • CIOMSForm

         CDSCO(India)andPharmacovigilance

       • D&CActandScheduleY

       • DifferencesinIndianandglobalpharmacovigilancerequirements

RecommendedBooks(Latestedition):

1. TextbookofPharmacovigilance:SKGupta,JaypeeBrothers,Medical Publishers.

2. PracticalDrugSafetyfromAtoZByBartonCobert,PierreBiron,JonesandBartlettPubli shers.

3. Mann'sPharmacovigilance:ElizabethB.Andrews,Nicholas,WileyPublishers.

4. Stephens'DetectionofNewAdverseDrug Reactions:JohnTalbot,PatrickWalle,WileyPublishers.

5. AnIntroductiontoPharmacovigilance:PatrickWaller,WileyPublishers.

6. Cobert'sManualofDrugSafetyandPharmacovigilance:BartonCobert,Jones&Bartlett Publishers.

7. TextbookofPharmacoepidemiologeditedbyBrianL.Strom,StephenEKimmel,SeanH ennessy,WileyPublishers.

8. ATextbookofClinicalPharmacyPractice- EssentialConceptsandSkills:G.Parthasarathi,Karin NyfortHansen,MilapC.Nahata

9. NationalFormularyofIndia

10. TextBookofMedicinebyYashpal Munjal

11. TextbookofPharmacovigilance:conceptandpracticebyGPMohantaandPKManna

12. http://www.whoumc.org/DynPage.aspx?id=105825&mn1=7347&mn2=7259&mn

    3=7297

13. http://www.ich.org/

14. http://www.cioms.ch/

15. http://cdsco.nic.in/

16. http://www.who.int/vaccine_safety/en/

17. http://www.ipc.gov.in/PvPI/pv_home.html

BP806ET.QUALITYCONTROLANDSTANDARDIZATIONOFHERBALS

(Theory)

Scope: In this subject the student learns about the various methods and guidelines forevaluation and standardization of herbs and herbal drugs. The subject also provides anopportunity forthestudenttolearncGMP,GAPandGLPintraditionalsystemofmedicines.

Objectives:Upon completionofthesubjectstudentshallbeableto;

1. knowWHO guidelines forqualitycontrol ofherbal drugs

2. knowQualityassurance in herbaldrugindustry

3. knowtheregulatoryapprovalprocessandtheirregistrationinIndianandintern ationalmarkets

4. appreciateEUandICH guidelinesforqualitycontrolofherbaldrugs

UnitI 10 hours

Basictestsfordrugs–Pharmaceuticalsubstances,Medicinalplantsmaterialsanddosageforms WHO guidelines for quality control of herbal drugs.Evaluationofcommercialcrudedrugsintended

foruse

UnitII 10 hours

QualityassuranceinherbaldrugindustryofcGMP,GAP,GMPandGLPintraditional system of medicine.

WHOGuidelinesoncurrentgoodmanufacturingPractices(cGMP)forHerbalMedicinesWHO Guidelines onGACPforMedicinal Plants.

UnitIII 10 hours

EU andICHguidelinesfor qualitycontrol ofherbal drugs. ResearchGuidelinesforEvaluatingtheSafetyand EfficacyofHerbal Medicines

UnitIV 08hours

Stabilitytestingofherbalmedicines.Applicationofvariouschromatographictechniquesinstand ardizationof herbal products.

PreparationofdocumentsfornewdrugapplicationandexportregistrationGMP requirementsandDrugs&CosmeticsAct provisions.

UnitV 07 hours

Regulatoryrequirements forherbalmedicines. WHOguidelinesonsafetymonitoringofherbalmedicinesinpharmacovigilancesystemsComparisonofv arious HerbalPharmacopoeias.

Roleofchemical andbiologicalmarkersinstandardizationofherbalproducts

Recommended Books:(LatestEditions

1. PharmacognosybyTreaseandEvans

2. PharmacognosybyKokate,PurohitandGokhale

3. Rangari,V.D.,Text bookofPharmacognosyandPhytochemistryVol.I,CarrierPub.,2006.

4. Aggrawal,S.S.,HerbalDrugTechnology.UniversitiesPress,2002.

5. EMEA. Guidelines on Quality of Herbal Medicinal Products/Traditional MedicinalProducts,

6. Mukherjee, P.W. Quality Control of Herbal Drugs: An Approach to Evaluation ofBotanicals.BusinessHorizonsPublishers,NewDelhi,India,2002.

7. Shinde M.V., Dhalwal K., Potdar K., Mahadik K. Application of quality controlprinciplestoherbaldrugs.InternationalJournalofPhytomedicine1(2009);p.4- 8.

8. WHO. Quality Control Methods for Medicinal Plant Materials, World HealthOrganization,Geneva,1998.WHO.GuidelinesfortheAppropriateUseofHerba lMedicines. WHO Regional Publications, Western Pacific Series No 3, WHORegional officefortheWesternPacific,Manila,1998.

9. WHO. TheInternationalPharmacopeia,Vol. 2:QualitySpecifications, 3rdedn.WorldHealthOrganization,Geneva,1981.

10. WHO. Quality Control Methods for Medicinal Plant Materials. World HealthOrganization,Geneva, 1999.

11. WHO. WHO Global Atlas of Traditional, Complementary and AlternativeMedicine. 2 vol. set. Vol. 1 contains text and Vol. 2, maps. World HealthOrganization,Geneva, 2005.

12. WHO.GuidelinesonGoodAgriculturalandCollectionPractices(GACP)forMedi cinalPlants.WorldHealthOrganization,Geneva,2004.

    BP807ET.COMPUTERAIDEDDRUGDESIGN(Theory)

    
    

    45HoursS cope: This subject is designed to provide detailed knowledge of rational drug designprocessand varioustechniques usedinrational drugdesign process.

    Objectives:Upon completionofthecourse,thestudentshallbeabletounderstand

    • Design anddiscoveryofleadmolecules

    • The role ofdrugdesignin drugdiscoveryprocess

    • TheconceptofQSAR anddocking

    • Variousstrategiestodevelopnewdruglikemolecules.

    • Thedesign ofnewdrugmolecules usingmolecularmodelingsoftware

CourseContent:

UNIT-I 10Hours

IntroductiontoDrugDiscoveryandDevelopment Stages ofdrugdiscoveryanddevelopment LeaddiscoveryandAnalogBased DrugDesign

Rationalapproachestoleaddiscovery basedontraditionalmedicine,Random

screening, Non-random screening, serendipitous drug discovery,leaddiscoverybasedondrugmetabolism,leaddiscoverybasedoncli nicalobservation.

Analog BasedDrug

Design:Bioisosterism,Classification,Bioisostericreplacement. Anythreecasestudies

UNIT-II 10Hours

QuantitativeStructureActivityRelationship(QSAR) SARversusQSAR,HistoryanddevelopmentofQSAR,Typesofphysicochemi cal parameters, experimental and theoretical approaches forthe

determination ofphysicochemical parameters such as Partitioncoefficient,

Hammet’ssubstituent constant and Tafts steric constant.Hanschanalysis,FreeWilsonanalysis,3D- QSARapproacheslikeCOMFAandCOMSIA.

UNIT-III 10Hours

MolecularModelingandvirtualscreeningtechniques VirtualScreeningtechniques:Druglikenessscreening,Conceptofpharm acophoremappingandpharmacophorebasedScreening,

Moleculardocking:Rigiddocking,flexibledocking,manualdocking,Docking based screening.Denovo drugdesign.

UNIT-IV 08Hours

Informatics&Methodsindrugdesign IntroductiontoBioinformatics,chemoinformatics.ADMEdatabases,chemic al,biochemicalandpharmaceuticaldatabases.

UNIT-V 07Hours

Molecular Modeling: Introduction to molecular mechanics and quantummechanics.Energy Minimization methods and Conformational Analysis,global conformational minimadetermination.

Recommended Books(LatestEditions)

1. RobertGCK, ed.,“DrugAction at theMolecularLevel”UniversityPrak PressBaltimore.

2. MartinYC.“QuantitativeDrugDesign”Dekker,NewYork.

3. DelgadoJN,RemersWAeds“Wilson&Gisvolds’sTextBookofOrganicMedicinal&P harmaceuticalChemistry”Lippincott,NewYork.

4. Foye WO“Principles ofMedicinalchemistry‘Lea&Febiger.

5. KorolkovasA,BurckhalterJH.“EssentialsofMedicinalChemistry”WileyInterscience

   .

6. Wolf ME, ed “The Basis of Medicinal Chemistry, Burger’s Medicinal Chemistry”JohnWiley&Sons,NewYork.

7. PatrickGraham,L.,AnIntroductiontoMedicinalChemistry,OxfordUniversityPress.

8. SmithHJ,WilliamsH,eds,“IntroductiontotheprinciplesofDrugDesign”WrightBosto n.

9. SilvermanR.B.“TheorganicChemistryofDrugDesignandDrugAction”AcademicPre ss NewYork.

   BP808ET:CELLANDMOLECULARBIOLOGY(Elective subject)

   45Hours

   
   

   Scope:

   • Cellbiology isabranchof biology thatstudies cells –their physiologicalproperties,theirstructure,the organelles theycontain,interactionswiththeirenvironment,theirlifecycle,division,deathand cellfunction.

   • Thisisdonebothonamicroscopicandmolecularlevel.

   • Cell biologyresearchencompassesboththegreatdiversityofsingle- celledorganismslike bacteria and protozoa,aswellasthemany specializedcellsinmulti-cellularorganismssuchas humans,plants,andsponges.

     
     

     Objectives:Upon completionofthesubjectstudentshallbeableto;

   • Summarize cellandmolecularbiologyhistory.

   • Summarizecellularfunctioningandcomposition.

   • Describethechemicalfoundationsofcellbiology.

   • SummarizetheDNApropertiesofcellbiology.

   • Describeproteinstructureandfunction.

   • Describecellularmembranestructureandfunction.

   • Describebasicmoleculargeneticmechanisms.

   • SummarizetheCellCycle

Coursecontent:

UnitI 10Hours

1. CellandMolecularBiology:DefinitionstheoryandbasicsandApplications.

2. CellandMolecular Biology:HistoryandSummation.

3. Propertiesofcellsandcellmembrane.

4. ProkaryoticversusEukaryotic

5. CellularReproduction

6. ChemicalFoundations–anIntroductionandReactions(Types)

UnitII 10Hours

1. DNA andtheFlowofMolecularInformation

2. DNAFunctioning

3. DNAandRNA

4. TypesofRNA

5. TranscriptionandTranslation

UnitIII 10Hours

1. Proteins: DefinedandAminoAcids

2. ProteinStructure

3. RegularitiesinProteinPathways

4. CellularProcesses

5. PositiveControlandsignificanceofProteinSynthesis

UnitIV 08Hours

1. ScienceofGenetics

2. TransgenicsandGenomicAnalysis

3. CellCycleanalysis

4. MitosisandMeiosis

5. CellularActivitiesandCheckpoints

UnitV 07Hours

1. CellSignals:Introduction

2. ReceptorsforCellSignals

3. SignalingPathways:Overview

4. MisregulationofSignalingPathways

5. Protein-Kinases:Functioning

RecommendedBooks(latestedition):

1. W.B.HugoandA.D.Russel:PharmaceuticalMicrobiology,BlackwellScientificpubl ications,OxfordLondon.

2. PrescottandDunn.,IndustrialMicrobiology,4thedition,CBSPublishers&Distr ibutors,Delhi.

3. Pelczar,ChanKreig,Microbiology,TataMcGrawHilledn.

4. MalcolmHarris,BalliereTindallandCox:PharmaceuticalMicrobiology.

5. Rose:IndustrialMicrobiology.

6. Probisher,Hinsdilletal:FundamentalsofMicrobiology,9thed.Japan

7. CooperandGunn’s:TutorialPharmacy,CBSPublisherandDistribution.

8. Peppler:MicrobialTechnology.

9. Edward:FundamentalsofMicrobiology.

10. N.K.Jain:PharmaceuticalMicrobiology,VallabhPrakashan,Delhi

11. Bergeys manual of systematic bacteriology, Williams and Wilkins- A Waverlycompany

12. B.R. Glick and J.J. Pasternak: Molecular Biotechnology: Principles andApplicationsofRecombinantDNA: ASMPress WashingtonD.C.

13. RAGoldshyet.al.,:KubyImmunology.

BP809ET.COSMETICSCIENCE(Theory)

45Hours

UNITI 10Hours

Classificationofcosmeticandcosmeceuticalproducts DefinitionofcosmeticsasperIndianandEUregulations,Evolutionofcosmeceuticalsfromcosm etics,cosmetics as quasiandOTC drugs

Cosmetic excipients: Surfactants, rheology modifiers, humectants, emollients,preservatives.Classification andapplication Skin:Basicstructureandfunctionofskin.

Hair:Basicstructureofhair.Hairgrowthcycle. OralCavity:Commonproblemassociatedwithteethandgums.

UNITII 10Hours

Principlesof formulationandbuildingblocksofskincareproducts:

Facewash, Moisturizingcream,ColdCream,Vanishingcreamandtheiradvantagesanddisadvantages.Appl ication of these products in formulation of cosmecuticals.Antiperspants&deodorants- Actives&mechanismofaction.

Principlesof formulationandbuildingblocksofHaircareproducts: Conditioningshampoo,Hairconditioner,anti- dandruffshampoo.Hairoils.

Chemistry and formulation of Para-phylene diamine based hair dye.Principles of formulation and building blocks of oral care products:Toothpasteforbleedinggums,sensitiveteeth.Teethwhitening,Mouthw ash.

UNITIII 10Hours

Sunprotection,ClassificationofSunscreens andSPF.

Roleofherbsin cosmetics:

Skin Care:Aloe and turmericHaircare:Hennaand amla.

Oralcare:Neemandclove

Analyticalcosmetics:BIS specificationandanalyticalmethodsforshampoo,skin- creamandtoothpaste.

UNITIV 08Hours.

PrinciplesofCosmeticEvaluation:Principlesofsebumeter,corneometer.MeasurementofTEW L,Skin Color,Hairtensilestrength,Haircombingproperties Soaps,andsyndetbars.Evolutionandskinbenfits.

UNITV 07Hours

Oilyand dryskin,causesleadingtodryskin, skinmoisturisation.Basic understandingoftheterms Comedogenic,dermatitis.

Cosmetic problems associated with Hair and scalp: Dandruff, Hair fall causesCosmeticproblemsassociatedwithskin:blemishes,wrinkles,acne,pricklyheatandb odyodor.

AntiperspirantsandDeodorants-Activesandmechanismofaction

References

1. Harry’sCosmeticology,Wilkinson,Moore,SeventhEdition,George Godwin.

2. Cosmetics– Formulations,ManufacturingandQualityControl,P.P.Sharma,4thEdition,VandanaPub lications Pvt.Ltd., Delhi.

3. Text bookof cosmelicologybySanju Nanda&RoopK. Khar, TataPublishers.

   BP810ET.EXPERIMENTAL PHARMACOLOGY (PHARMACOLOGICALSCREENINGMETHODS)

   45Hours

   
   

   Scope:Thissubjectisdesignedtoimpartthebasicknowledgeofpreclinicalstudiesinexperimentalanimals includingdesign,conductandinterpretationsofresults.

   
   

   Objectives

   Uponcompletionofthecoursethestudentshallbeableto,

   • Appreciatetheapplications ofvarious commonlyusedlaboratoryanimals.

   • Appreciateanddemonstrate

     thevariousscreeningmethodsusedinpreclinicalresearc

     h

   • Appreciateanddemonstratetheimportanceofbiostatisticsandresearchmethodology

   • Designandexecutearesearch hypothesisindependently

RecommendedBooks(latestedition):

1. FundamentalsofexperimentalPharmacology-byM.N.Ghosh

2. HandbookofExperimentalPharmacology-S.K.Kulakarni

3. CPCSEAguidelinesforlaboratoryanimalfacility.

4. DrugdiscoveryandEvaluationbyVogelH.G.

5. DrugScreeningMethodsbySureshKumar GuptaandS. K. Gupta

6. IntroductiontobiostatisticsandresearchmethodsbyPSSSundarRaoandJRichard

   BP811ET. ADVANCEDINSTRUMENTATIONTECHNIQUES

   45Hours

   
   

   Scope: This subject deals with the application of instrumental methods in qualitative andquantitative analysis of drugs. This subject is designed to impart advanced knowledge ontheprinciplesandinstrumentationofspectroscopicandchromatographichyphenatedtechniq ues.Thisalsoemphasizesontheoreticalandpracticalknowledgeonmodernanalyticalinstrument s that areusedfordrugtesting.

   
   

   Objectives:Upon completionofthecoursethestudentshallbeableto

   • understandtheadvancedinstrumentsusedanditsapplicationsindruganalysis

   • understandthechromatographicseparationandanalysisofdrugs.

   • understandthecalibrationofvariousanalyticalinstruments

   • knowanalysisof drugsusingvariousanalyticalinstruments.

CourseContent:

UNIT-I 10Hours

NuclearMagneticResonancespectroscopy

Principles of H-NMR and C-NMR, chemical shift, factors affecting chemicalshift, coupling constant, Spin - spin coupling, relaxation, instrumentation andapplications

MassSpectrometry-Principles,Fragmentation,Ionizationtechniques– Electronimpact,chemicalionization,MALDI,FAB,Analyzers- TimeofflightandQuadrupole,instrumentation, applications

UNIT-II 10Hours

ThermalMethods ofAnalysis: Principles, instrumentationand applicationsof ThermogravimetricAnalysis (TGA), Differential Thermal Analysis (DTA),Differential ScanningCalorimetry(DSC)

1. Ray Diffraction Methods: Origin of X-rays, basic aspects of crystals, X- ray

   Crystallography, rotating crystal technique, single crystal diffraction,powderdiffraction,structural elucidationandapplications.

   
   

   UNIT-III 10Hours

   Calibrationandvalidation-asperICHandUSFDAguidelines CalibrationoffollowingInstruments

   
   

   Electronicbalance,UV-Visiblespectrophotometer,IRspectrophotometer,

   Fluorimeter,FlamePhotometer,HPLCandGC

   
   

   UNIT-IV 08Hours

   Radio immune assay:Importance, various components, Principle, differentmethods,Limitation andApplicationsofRadioimmuno assay Extractiontechniques:Generalprincipleandprocedureinvolvedinthesolidphaseextr action andliquid-liquidextraction

   
   

   UNIT-V 07Hours

   Hyphenatedtechniques-LC-MS/MS,GC-MS/MS,HPTLC-MS.

   
   

   RecommendedBooks(LatestEditions)

   1. InstrumentalMethodsofChemicalAnalysis byB.KSharma

   2. Organic spectroscopybyY.RSharma

   3. TextbookofPharmaceutical Analysis byKennethA.Connors

   4. Vogel’sTextbookofQuantitativeChemicalAnalysisbyA.I.Vogel

   5. Practical PharmaceuticalChemistrybyA.H.BeckettandJ.B.Stenlake

   6. OrganicChemistrybyI.L.Finar

   7. Organic spectroscopybyWilliamKemp

   8. QuantitativeAnalysisofDrugsbyD.C.Garrett

   9. Quantitative Analysisof Drugs in PharmaceuticalFormulationsbyP.D. Sethi

   10. Spectrophotometric identification of OrganicCompoundsbySilverstein

BP812ET.DIETARYSUPPLEMENTSANDNUTRACEUTICALS

No.ofhours:3 Tutorial:1 Credit point:4Scope:

Thissubjectcoversfoundationaltopicthatareimportantforunderstandingtheneedandrequirementso fdietarysupplementsamongdifferent groupsinthepopulation.

Objective:

This module aims to provide an understanding of the concepts behind the theoreticalapplicationsofdietarysupplements.Bytheendofthecourse,studentsshouldbe ableto:

1. Understandtheneedofsupplementsbythedifferentgroupofpeopletomaintainhealthy life.

2. Understandtheoutcomeofdeficienciesindietarysupplements.

3. Appreciatethecomponentsindietarysupplementsandtheapplication.

4. Appreciatetheregulatoryand commercialaspectsofdietarysupplementsincludinghealthclaims.

   UNITI 07 hours

   1. Definitions of Functional foods, Nutraceuticals and Dietary supplements. Classificationof Nutraceuticals, Health problems and diseases that can be prevented or cured byNutraceuticals i.e. weight control, diabetes, cancer, heart disease, stress, osteoarthritis,hypertensionetc.

   2. Public health nutrition, maternal and child nutrition, nutrition and ageing, nutritioneducationincommunity.

   3. Source, Name of marker compounds and their chemical nature, Medicinal uses andhealthbenefitsoffollowingusedasnutraceuticals/functionalfoods:Spirulina,Soyabean, Ginseng, Garlic, Broccoli,Gingko,Flaxseeds

UNITII 15 hours

Phytochemicalsasnutraceuticals:Occurrenceandcharacteristicfeatures(chemicalnaturemedicinal benefits)offollowing

1. Carotenoids-αandβ-Carotene,Lycopene,Xanthophylls,leutin

2. Sulfides:Diallylsulfides,Allyltrisulfide.

3. Polyphenolics:Reservetrol

4. Flavonoids-Rutin,Naringin,Quercitin,Anthocyanidins,catechins,Flavones

5. Prebiotics/Probiotics.:Fructooligosaccharides,Lactobacillum

6. Phytoestrogens:Isoflavones,daidzein,Geebustin,lignans

7. Tocopherols

8. Proteins,vitamins, minerals,cereal, vegetablesandbeveragesasfunctionalfoods: oats,wheatbran,ricebran, sea foods, coffee,teaandthelike.

UNITIII 07 hours

1. Introduction to free radicals: Free radicals, reactive oxygen species, production of freeradicalsincells,damagingreactionsoffreeradicalsonlipids,proteins,Carbohydrates,nu cleicacids.

2. Dietaryfibresandcomplexcarbohydrates asfunctionalfoodingredients..

UNITIV 10 hours

1. FreeradicalsinDiabetesmellitus, Inflammation, Ischemicreperfusioninjury,Cancer,Atherosclerosis, Free radicals in brain metabolism and pathology, kidney damage,muscle damage. Free radicals involvement in other disorders. Free radicals theory ofageing.

2. Antioxidants: Endogenous antioxidants – enzymatic and nonenzymatic antioxidantdefence,Superoxidedismutase,catalase,Glutathioneperoxidase,GlutathioneV itaminC,VitaminE,α-Lipoicacid,melatonin Syntheticantioxidants:ButylatedhydroxyToluene,ButylatedhydroxyAnisole.

3. Functionalfoodsforchronicdiseaseprevention

UNITV 06 hours

1. Effectofprocessing,storageandinteractionsofvariousenvironmentalfactorsonthepotentialofnut raceuticals.

2. RegulatoryAspects;FSSAI,FDA,FPO,MPO,AGMARK.HACCPandGMPsonFoodSafety.Ad ulterationoffoods.

   
   

3. PharmacopoeialSpecificationsfordietarysupplementsandnutraceuticals.

   
   

   References:

   
   

   1. DieteticsbySriLakshmi

   2. RoleofdietaryfibresandneutraceuticalsinpreventingdiseasesbyK.TAgustiandP.Faizal:BS Punblication.

   3. Advanced NutritionalTherapiesbyCooper.K.A., (1996).

   4. TheFoodPharmacybyJeanCarper,Simon&Schuster,UKLtd.,(1988).

   5. PrescriptionforNutritionalHealingbyJamesF.BalchandPhyllisA.Balch2ndEdn.,AveryPubl ishingGroup,NY(1997).

   6. G.GibsonandC.williamsEditors 2000FunctionalfoodsWoodheadPubl.Co.London.

   7. Goldberg,I.FunctionalFoods.1994.ChapmanandHall,New York.

   8. Labuza,T.P.2000FunctionalFoodsandDietarySupplements:Safety,GoodManufacturing Practice(GMPs) and Shelf Life Testing inEssentials of FunctionalFoods M.K.Sachmidland T.P.Labuzaeds.AspenPress.

   9. HandbookofNutraceuticalsandFunctionalFoods,ThirdEdition(ModernNutrition)

   10. Shils, ME, Olson, JA, Shike, M. 1994 Modern Nutrition in Health and Disease.Eighthedition.LeaandFebiger

       SemesterVIII–Elective course on PharmaceuticalProductDevelopmentNoofHours:3 Tutorial:1

       Creditpoints:4

       Unit-I 10Hours

       Introduction to pharmaceutical product development, objectives, regulations related topreformulation,formulationdevelopment,stabilityassessment,manufacturingandqual itycontroltestingofdifferent types ofdosageforms

       
       

       Unit-II 10Hours

       Anadvancedstudy ofPharmaceuticalExcipientsinpharmaceuticalproductdevelopmentwithaspecialreferenceto thefollowingcategories

       1. Solventsandsolubilizers

       2. Cyclodextrinsandtheirapplications

       3. Non-ionicsurfactantsandtheirapplications

       4. Polyethyleneglycolsandsorbitols

       5. Suspendingandemulsifyingagents

       6. Semisolidexcipients

Unit-III 10Hours

AnadvancedstudyofPharmaceuticalExcipientsinpharmaceuticalproductdevelopmentw ithaspecial referencetothefollowingcategories

1. Tabletandcapsuleexcipients

2. Directlycompressiblevehicles

3. Coatmaterials

4. Excipientsinparenteralandaerosolsproducts

5. ExcipientsforformulationofNDDS Selectionandapplicationofexcipientsinpharmaceuticalformulationswithspecificindustr ialapplications

Unit-IV 08Hours

Optimizationtechniquesinpharmaceuticalproductdevelopment.Astudy ofvariousoptimizationtechniquesforpharmaceuticalproductdevelopmentwithspecifice xamples.Optimization by factorial designs and their applications.A study of QbD and itsapplicationinpharmaceutical productdevelopment.

Unit-V 07Hours

Selectionandqualitycontroltestingofpackagingmaterialsforpharmaceuticalproductdev elopment-regulatoryconsiderations.

SEMESTERVIII

BP801T.BIOSTATISITCSANDRESEARCHMETHODOLOGY(Theory)

45Hours

Scope: To understand the applications of Biostatics in Pharmacy. This subject deals withdescriptive statistics,Graphics, Correlation,Regression, logistic regression Probabilitytheory,Samplingtechnique,Parametrictests,NonParametrictests,ANOVA,Introd uction to Design of Experiments, Phases of Clinical trials and Observational andExperimentalstudies,SPSS,RandMINITABstatisticalsoftware’s,analyzingthestatistical datausingExcel.

Objectives:Upon completionofthecoursethestudentshallbeableto

• KnowtheoperationofM.S.Excel,SPSS,RandMINITAB®, DoE(DesignofExperiment)

• Knowthevariousstatisticaltechniquestosolvestatisticalproblems

• Appreciatestatisticaltechniquesinsolvingtheproblems.

Coursecontent:

Unit-I 10Hours

Introduction:Statistics,Biostatistics,Frequencydistribution

Measures of central tendency:Mean, Median, Mode- Pharmaceutical examplesMeasures of dispersion: Dispersion, Range, standard deviation,Pharmaceuticalproblems

Correlation: Definition, Karl Pearson’s coefficient of correlation, Multiple correlation - Pharmaceuticalsexamples

Unit-II 10Hours

Regression: Curve fittingbythe methodof leastsquares, fittingthelines y=a+bxandx

=a+by,Multipleregression,standarderrorofregression– PharmaceuticalExamplesProbability:Definition of probability, Binomial distribution, Normal distribution,Poisson’sdistribution,properties -problems Sample,Population,largesample,smallsample, Nullhypothesis,alternativehypothesis,sampling, essence of sampling, types of sampling, Error-I type,Error-II type, Standarderrorofmean(SEM)-Pharmaceutical examples Parametric test: t-test(Sample, Pooled or Unpaired and Paired) , ANOVA, (One wayandTwoway),Least Significancedifference

Unit-III 10Hours

Non Parametric tests: Wilcoxon Rank Sum Test, Mann-Whitney U test, Kruskal- Wallistest,FriedmanTest

Introduction to Research: Need for research, Need for design of Experiments,ExperientialDesign Technique,plagiarism

Graphs: Histogram, Pie Chart, Cubic Graph, response surface plot, Counter Plot graphDesigningthemethodology:SamplesizedeterminationandPowerofastudy,Reportw ritingandpresentationofdata,Protocol,Cohorts studies, Observational studies,Experimental studies,Designingclinical trial,various phases.

Unit-IV 8Hours

Blockingandconfoundingsystem forTwo-level factorials

Regression modeling: Hypothesis testing in Simple and Multiple regressionmodelsIntroductiontoPracticalcomponentsofIndustrialandClinicalTrialsPr oblems:StatisticalAnalysisUsingExcel,SPSS,MINITAB®,DESIGNOFEXPERIMENTS,R- OnlineStatisticalSoftware’stoIndustrialandClinical trialapproach

Unit-V 7Hours

Design andAnalysisofexperiments:

Factorial Design: Definition, 22, 23design. Advantage of factorial designResponseSurfacemethodology:Centralcompositedesign,Historicaldesign, OptimizationTechniques

RecommendedBooks(Latestedition):

1. Pharmaceuticalstatistics- Practicalandclinicalapplications,SanfordBolton,publisherMarcel DekkerInc.NewYork.

2. FundamentalofStatistics –HimalayaPublishingHouse-S.C.Guptha

3. DesignandAnalysisofExperiments–PHI LearningPrivateLimited,

   R.Pannerselvam,

4. Design and AnalysisofExperiments– WileyStudentsEdition,DouglasandC.Montgomery

Scope:

BP802TSOCIALAND PREVENTIVEPHARMACY (Theory)

Hours:45

The purpose of this course is to introduce to students a number of health issues and theirchallenges. This course also introduced a number of national health programmes. Therolesofthe pharmacistinthesecontextsarealso discussed.

Objectives:

Afterthesuccessfulcompletionofthiscourse,thestudentshallbeableto:

• Acquirehighconsciousness/realizationofcurrentissuesrelatedtohealthandpharmace uticalproblemswithinthe countryandworldwide.

• Have a critical wayofthinkingbasedon current healthcaredevelopment.

• Evaluate alternative ways of solving problems related tohealth andpharmaceuticalissues

Coursecontent:

UnitI: 10Hours

Concept of health and disease: Definition, concepts and evaluation of public health.Understanding the concept of prevention and control of disease, social causes of diseasesandsocial problems of thesick.

Social and health education: Food in relation to nutrition and health, Balanced diet,Nutritionaldeficiencies,Vitamindeficiencies,Malnutrition anditsprevention.

Sociology and health: Socio cultural factors related to health and disease, Impact ofurbanization onhealth anddisease, Povertyand health

Hygieneandhealth:personalhygieneandhealthcare; avoidablehabits

UnitII: 10Hours

Preventive medicine: General principles of prevention and control of diseases such ascholera,SARS,Ebolavirus,influenza,acuterespiratory infections,malaria,chickenguinea, dengue, lymphatic filariasis, pneumonia, hypertension, diabetes mellitus, cancer,drugaddiction-drugsubstanceabuse

UnitIII: 10Hours

National health programs, its objectives, functioning and outcome of the following:HIVANDAIDScontrolprogramme,TB,Integrateddiseasesurveillanceprogram(I DSP),Nationalleprosycontrolprogramme,Nationalmentalhealthprogram,National

programme for prevention and control of deafness, Universal immunization programme,Nationalprogrammeforcontrolofblindness,Pulsepolioprogramme.

UnitIV: 08Hours

National health intervention programme for mother and child, National family welfareprogramme, National tobacco control programme, National Malaria Prevention Program,National programme for the health care for the elderly, Social health programme; role ofWHOinIndian nationalprogram

UnitV: 07Hours

Community services in rural, urban and school health: Functions of PHC,Improvementin rural sanitation, national urban health mission, Health promotion and education inschool.

RecommendedBooks(Latestedition):

1. Short Textbook of Preventive and Social Medicine, Prabhakara GN, 2nd Edition,2010,ISBN: 9789380704104, JAYPEEPublications

2. Textbook of Preventive and Social Medicine (Mahajan and Gupta), Edited by RoyRabindra Nath, Saha Indranil, 4thEdition, 2013, ISBN: 9789350901878, JAYPEEPublications

3. Review of Preventive and Social Medicine (Including Biostatistics), Jain Vivek, 6thEdition,2014,ISBN: 9789351522331, JAYPEEPublications

4. EssentialsofCommunity Medicine—

   APracticalApproach,HiremathLalitaD,HiremathDhananjayaA,2ndEdition,2012,ISBN

   :9789350250440,JAYPEEPublications

5. ParkTextbook ofPreventiveandSocialMedicine,KPark,21stEdition,2011,ISBN- 14:9788190128285,BANARSIDASBHANOTPUBLISHERS.

6. CommunityPharmacyPractice,RameshAdepu,BSPpublishers, Hyderabad

Recommended Journals:

1. ResearchinSocialandAdministrativePharmacy,Elsevier,Ireland

BP803ET. Pharmaceutical Marketing Management (Theory)

45Hours

Scope:

The pharmaceutical industry not only needs highly qualified researchers, chemists and,technicalpeople, butalsorequires skilled managers who cantake the industry forwardby managing and taking the complex decisions which are imperative for the growth of theindustry. The KnowledgeandKnow-how ofmarketing managementgroomthe peoplefortakingachallenging rolein Sales and Productmanagement.

Course Objective: The course aims to provide an understanding of marketing conceptsandtechniques andtheirapplicationsinthepharmaceuticalindustry.

UnitI 10Hours

Marketing:

Definition, general concepts and scope of marketing; Distinction between marketing &selling; Marketing environment; Industry and competitive analysis; Analyzing consumerbuyingbehavior; industrial buyingbehavior.

Pharmaceuticalmarket:

Quantitative and qualitative aspects; size and composition of the market; demographicdescriptionsandsocio- psychologicalcharacteristicsoftheconsumer;marketsegmentation&targeting.Consumerprofi le;Motivationandprescribinghabitsofthephysician;patients' choice of physicianand retailpharmacist.Analyzing the Market;Roleofmarket research.

UnitII 10Hours

Productdecision:

Classification, product line and product mix decisions, product lifecycle,productportfolioanalysis;productpositioning;New productdecisions;Productbranding,packagingandlabelingdecisions,Productmanagementinp harmaceuticalindustry.

UnitIII 10Hours

Promotion:

Methods,determinantsofpromotionalmix,promotionalbudget;Anoverviewofpersonalselling

,advertising,directmail,journals,sampling,retailing, medicalexhibition,publicrelations,onlinepromotionaltechniques forOTCProducts.

160

UnitIV 10Hours

Pharmaceuticalmarketingchannels: Designingchannel,channelmembers,selectingtheappropriatechannel,conflictinchannels,phy sicaldistributionmanagement:Strategicimportance,tasksinphysicaldistributionmanagement.

Professionalsalesrepresentative(PSR): DutiesofPSR,purposeofdetailing,selectionandtraining,supervising,normsforcustomercalls, motivating,evaluating,compensationandfutureprospectsofthePSR.

UnitV 10Hours

Pricing:

Meaning, importance, objectives, determinants of price; pricing methods and strategies,issuesinpricemanagementinpharmaceuticalindustry.AnoverviewofDPCO(DrugP riceControlOrder)andNPPA(NationalPharmaceuticalPricingAuthority).

Emergingconceptsinmarketing:

Vertical & Horizontal Marketing; RuralMarketing; Consumerism; Industrial Marketing;GlobalMarketing.

Recommended Books:(LatestEditions)

1. PhilipKotlerandKevinLaneKeller:MarketingManagement,PrenticeHallofIndia,NewDel hi

2. Walker,BoydandLarreche:MarketingStrategy-PlanningandImplementation,TataMC GrawHill,NewDelhi.

3. DhruvGrewalandMichaelLevy:Marketing,TataMCGrawHill

4. ArunKumarandNMenakshi:MarketingManagement,VikasPublishing,India

5. RajanSaxena:MarketingManagement; TataMC Graw-Hill(IndiaEdition)

6. Ramaswamy,U.S&Nanakamari,S:MarketingManagemnt:GlobalPerspective,IndianCon text,MacmilanIndia,NewDelhi.

7. Shanker,Ravi:ServiceMarketing,ExcellBooks,NewDelhi

8. SubbaRaoChanganti,PharmaceuticalMarketinginIndia(GIFT– Excelseries)ExcelPublications.

   
   

   161

   BP804ET:PHARMACEUTICALREGULATORYSCIENCE(Theory)

   
   

   45Hours

   
   

   Scope: This course is designed to impart the fundamental knowledge on the regulatoryrequirementsforapprovalofnewdrugs, anddrugproductsinregulatedmarkets ofIndia & other countries like US, EU,Japan,Australia,UK etc.Itpreparesthestudentstolearnindetailonthe regulatoryrequirements,documentationrequirements,andregistrationprocedures formarketingthedrugproducts.

   
   

   Objectives:Upon completionofthesubjectstudentshallbeableto;

   1. Know about the processof drugdiscoveryanddevelopment

   2. Knowtheregulatoryauthoritiesandagenciesgoverningthemanufactureandsaleofpha rmaceuticals

   3. KnowtheregulatoryapprovalprocessandtheirregistrationinIndianandintern ationalmarkets

Coursecontent:

UnitI 10Hours

NewDrugDiscoveryanddevelopment

Stages of drug discovery, Drug development process, pre-clinical studies, non- clinicalactivities, clinical studies,Innovator andgenerics, Concept of generics, Generic drugproductdevelopment.

UnitII 10Hours

RegulatoryApprovalProcess

Approvalprocessesandtimelines involved inInvestigationalNew Drug (IND),NewDrug Application (NDA), Abbreviated New Drug Application (ANDA). Changes to anapprovedNDA/ ANDA.

Regulatoryauthorities andagencies

Overview of regulatory authorities of India, United States, European Union,Australia,Japan,Canada(Organizationstructureand typesofapplications)

UnitIII 10Hours

RegistrationofIndiandrugproductinoverseas market

Procedure for export of pharmaceutical products, Technical documentation, Drug MasterFiles(DMF),CommonTechnicalDocument(CTD),electronicCommonTechnical

162

Document(eCTD),ASEANCommonTechnicalDocument(ACTD)research.

UnitIV 08Hours

Clinicaltrials

Developingclinicaltrialprotocols,InstitutionalReviewBoard/IndependentEthicscommittee- formationandworkingprocedures,Informedconsentprocessandprocedures,GCPobligationso fInvestigators,sponsors&Monitors,Managing andMonitoringclinical trials,Pharmacovigilance-safetymonitoringinclinical trials

UnitV 07Hours

RegulatoryConcepts

Basicterminology,guidance,guidelines,regulations,LawsandActs,Orangebook,FederalReg ister,CodeofFederalRegulatory, Purplebook

Recommended books(Latestedition):

1. DrugRegulatoryAffairsbySachinItkar,Dr.N.S.Vyawahare,Nirali Prakashan.

2. The Pharmaceutical Regulatory Process, Second Edition Edited by Ira R. Berry andRobertP. Martin, Drugs and the Pharmaceutical Sciences,Vol.185. Informa HealthcarePublishers.

3. NewDrugApprovalProcess:AcceleratingGlobalRegistrationsByRichardAGuar ino,MD,5thedition,DrugsandthePharmaceuticalSciences,Vol.190.

4. Guidebookfordrugregulatorysubmissions/SandyWeinberg.ByJohnWiley&Sons.I nc.

5. FDARegulatoryAffairs:aguideforprescriptiondrugs,medicaldevices,andbiolo gics/edited byDouglas J. Pisano,David Mantus.

6. GenericDrugProductDevelopment,SolidOralDosageforms,LeonShargelandIsader Kaufer,Marcel Dekkerseries,Vol.143

7. ClinicalTrialsandHumanResearch:APracticalGuidetoRegulatoryComplianceByFay A.RozovskyandRodneyK.Adams

8. PrinciplesandPracticesof ClinicalResearch, SecondEditionEditedby JohnI.GallinandFrederick P.Ognibene

9. Drugs:FromDiscoveryto Approval,SecondEditionByRickNg

   
   

   163

   BP805T:PHARMACOVIGILANCE(Theory)

   45hours

   
   

   Scope: This paper will provide an opportunity for the student to learn about development ofpharmacovigilanceasa science, basic terminologies used inpharmacovigilance, globalscenarioofPharmacovigilance,trainstudentsonestablishingpharmacovigilanceprogrammeinan organization, various methods that can be used to generate safety data and signal detection. Thispaperalsodevelopstheskillsof classifyingdrugs,diseasesandadversedrugreactions.

   
   

   Objectives:

   
   

   At completion of this paper it is expected that students will be able to (know, do, andappreciate):

   1. Whydrugsafetymonitoringisimportant?

   2. Historyanddevelopmentofpharmacovigilance

   3. Nationalandinternationalscenarioofpharmacovigilance

   4. Dictionaries,codingandterminologiesusedinpharmacovigilance

   5. Detectionofnewadversedrugreactionsandtheirassessment

   6. Internationalstandardsforclassificationofdiseasesanddrugs

   7. Adversedrugreactionreportingsystemsandcommunicationinpharmacovigilance

   8. Methodstogeneratesafetydataduringpreclinical,clinicalandpostapprovalphasesofdrugs’ life cycle

   9. Drugsafetyevaluationinpaediatrics,geriatrics,pregnancyandlactation

   10. PharmacovigilanceProgramofIndia(PvPI)requirement for ADRreportinginIndia

   11. ICHguidelinesforICSR,PSUR,expeditedreporting,pharmacovigilanceplanning

   12. CIOMSrequirementsforADRreporting

   13. Writingcasenarrativesofadverseeventsandtheirquality.

       
       

       CourseContent

       
       

       UnitI 10Hours

       IntroductiontoPharmacovigilance

       • HistoryanddevelopmentofPharmacovigilance

       • ImportanceofsafetymonitoringofMedicine

       • WHOinternationaldrugmonitoringprogramme

       • PharmacovigilanceProgramofIndia(PvPI)

         Introductiontoadversedrugreactions

       • DefinitionsandclassificationofADRs

       • Detectionandreporting

       • MethodsinCausalityassessment

       • Severityandseriousnessassessment

       • Predictabilityandpreventabilityassessment

       • Managementofadversedrugreactions

         Basicterminologiesusedinpharmacovigilance

         
         

         164

       • Terminologiesofadversemedicationrelatedevents

       • Regulatoryterminologies

         Unit II 10hours

         Druganddiseaseclassification

       • Anatomical,therapeuticandchemicalclassificationofdrugs

       • Internationalclassificationofdiseases

       • Dailydefineddoses

       • InternationalNonproprietaryNamesfordrugs

         Drugdictionariesandcodinginpharmacovigilance

       • WHOadversereactionterminologies

       • MedDRAandStandardisedMedDRAqueries

       • WHOdrugdictionary

       • Eudravigilancemedicinalproductdictionary

         Informationresourcesinpharmacovigilance

       • Basicdruginformationresources

       • SpecialisedresourcesforADRs

         Establishingpharmacovigilanceprogramme

       • Establishinginahospital

       • Establishment &operationofdrugsafetydepartment inindustry

       • ContractResearchOrganisations(CROs)

       • Establishinganationalprogramme

         
         

         Unit III 10Hours

         Vaccinesafetysurveillance

       • VaccinePharmacovigilance

       • Vaccinationfailure

       • Adverseeventsfollowingimmunization

         Pharmacovigilancemethods

       • Passivesurveillance–Spontaneousreportsandcaseseries

       • Stimulatedreporting

       • Activesurveillance–Sentinelsites,drugeventmonitoringandregistries

       • Comparativeobservationalstudies– Crosssectionalstudy,casecontrolstudyandcohort study

       • Targetedclinicalinvestigations

         Communicationinpharmacovigilance

       • EffectivecommunicationinPharmacovigilance

       • CommunicationinDrugSafetyCrisismanagement

       • CommunicatingwithRegulatoryAgencies,BusinessPartners,Healthcarefacilities&Me dia

         
         

         165

         UnitIV 8Hours

         
         

         Safetydatageneration

       • Preclinicalphase

       • Clinicalphase

       • Postapprovalphase(PMS)

         ICHGuidelinesforPharmacovigilance

       • OrganizationandobjectivesofICH

       • Expeditedreporting

       • Individualcasesafetyreports

       • Periodicsafetyupdatereports

       • Postapprovalexpeditedreporting

       • Pharmacovigilanceplanning

       • Goodclinicalpracticeinpharmacovigilancestudies

         
         

         UnitV 7hours

         Pharmacogenomicsofadversedrugreactions

       • GeneticsrelatedADRwithexamplefocusingPKparameters.

         Drugsafetyevaluationinspecialpopulation

       • Paediatrics

       • Pregnancyandlactation

       • Geriatrics

         CIOMS

       • CIOMSWorkingGroups

       • CIOMSForm

         CDSCO(India)andPharmacovigilance

       • D&CActandScheduleY

       • DifferencesinIndianandglobalpharmacovigilancerequirements

RecommendedBooks(Latestedition):

1. TextbookofPharmacovigilance:SKGupta,JaypeeBrothers,Medical Publishers.

2. PracticalDrugSafetyfromAtoZByBartonCobert,PierreBiron,JonesandBartlettPubli shers.

3. Mann'sPharmacovigilance:ElizabethB.Andrews,Nicholas,WileyPublishers.

4. Stephens'DetectionofNewAdverseDrug Reactions:JohnTalbot,PatrickWalle,WileyPublishers.

5. AnIntroductiontoPharmacovigilance:PatrickWaller,WileyPublishers.

6. Cobert'sManualofDrugSafetyandPharmacovigilance:BartonCobert,Jones&Bartlett Publishers.

7. TextbookofPharmacoepidemiologeditedbyBrianL.Strom,StephenEKimmel,SeanH ennessy,WileyPublishers.

8. ATextbookofClinicalPharmacyPractice- EssentialConceptsandSkills:G.Parthasarathi,Karin NyfortHansen,MilapC.Nahata

9. NationalFormularyofIndia

10. TextBookofMedicinebyYashpal Munjal

11. TextbookofPharmacovigilance:conceptandpracticebyGPMohantaandPKManna

12. http://www.whoumc.org/DynPage.aspx?id=105825&mn1=7347&mn2=7259&mn

    3=7297

13. http://www.ich.org/

14. http://www.cioms.ch/

15. http://cdsco.nic.in/

16. http://www.who.int/vaccine_safety/en/

17. http://www.ipc.gov.in/PvPI/pv_home.html

BP806ET.QUALITYCONTROLANDSTANDARDIZATIONOFHERBALS

(Theory)

Scope: In this subject the student learns about the various methods and guidelines forevaluation and standardization of herbs and herbal drugs. The subject also provides anopportunity forthestudenttolearncGMP,GAPandGLPintraditionalsystemofmedicines.

Objectives:Upon completionofthesubjectstudentshallbeableto;

1. knowWHO guidelines forqualitycontrol ofherbal drugs

2. knowQualityassurance in herbaldrugindustry

3. knowtheregulatoryapprovalprocessandtheirregistrationinIndianandintern ationalmarkets

4. appreciateEUandICH guidelinesforqualitycontrolofherbaldrugs

UnitI 10 hours

Basictestsfordrugs–Pharmaceuticalsubstances,Medicinalplantsmaterialsanddosageforms WHO guidelines for quality control of herbal drugs.Evaluationofcommercialcrudedrugsintended

foruse

UnitII 10 hours

QualityassuranceinherbaldrugindustryofcGMP,GAP,GMPandGLPintraditional system of medicine.

WHOGuidelinesoncurrentgoodmanufacturingPractices(cGMP)forHerbalMedicinesWHO Guidelines onGACPforMedicinal Plants.

UnitIII 10 hours

EU andICHguidelinesfor qualitycontrol ofherbal drugs. ResearchGuidelinesforEvaluatingtheSafetyand EfficacyofHerbal Medicines

UnitIV 08hours

Stabilitytestingofherbalmedicines.Applicationofvariouschromatographictechniquesinstand ardizationof herbal products.

PreparationofdocumentsfornewdrugapplicationandexportregistrationGMP requirementsandDrugs&CosmeticsAct provisions.

UnitV 07 hours

Regulatoryrequirements forherbalmedicines. WHOguidelinesonsafetymonitoringofherbalmedicinesinpharmacovigilancesystemsComparisonofv arious HerbalPharmacopoeias.

Roleofchemical andbiologicalmarkersinstandardizationofherbalproducts

Recommended Books:(LatestEditions

1. PharmacognosybyTreaseandEvans

2. PharmacognosybyKokate,PurohitandGokhale

3. Rangari,V.D.,Text bookofPharmacognosyandPhytochemistryVol.I,CarrierPub.,2006.

4. Aggrawal,S.S.,HerbalDrugTechnology.UniversitiesPress,2002.

5. EMEA. Guidelines on Quality of Herbal Medicinal Products/Traditional MedicinalProducts,

6. Mukherjee, P.W. Quality Control of Herbal Drugs: An Approach to Evaluation ofBotanicals.BusinessHorizonsPublishers,NewDelhi,India,2002.

7. Shinde M.V., Dhalwal K., Potdar K., Mahadik K. Application of quality controlprinciplestoherbaldrugs.InternationalJournalofPhytomedicine1(2009);p.4- 8.

8. WHO. Quality Control Methods for Medicinal Plant Materials, World HealthOrganization,Geneva,1998.WHO.GuidelinesfortheAppropriateUseofHerba lMedicines. WHO Regional Publications, Western Pacific Series No 3, WHORegional officefortheWesternPacific,Manila,1998.

9. WHO. TheInternationalPharmacopeia,Vol. 2:QualitySpecifications, 3rdedn.WorldHealthOrganization,Geneva,1981.

10. WHO. Quality Control Methods for Medicinal Plant Materials. World HealthOrganization,Geneva, 1999.

11. WHO. WHO Global Atlas of Traditional, Complementary and AlternativeMedicine. 2 vol. set. Vol. 1 contains text and Vol. 2, maps. World HealthOrganization,Geneva, 2005.

12. WHO.GuidelinesonGoodAgriculturalandCollectionPractices(GACP)forMedi cinalPlants.WorldHealthOrganization,Geneva,2004.

    BP807ET.COMPUTERAIDEDDRUGDESIGN(Theory)

    
    

    45HoursS cope: This subject is designed to provide detailed knowledge of rational drug designprocessand varioustechniques usedinrational drugdesign process.

    Objectives:Upon completionofthecourse,thestudentshallbeabletounderstand

    • Design anddiscoveryofleadmolecules

    • The role ofdrugdesignin drugdiscoveryprocess

    • TheconceptofQSAR anddocking

    • Variousstrategiestodevelopnewdruglikemolecules.

    • Thedesign ofnewdrugmolecules usingmolecularmodelingsoftware

CourseContent:

UNIT-I 10Hours

IntroductiontoDrugDiscoveryandDevelopment Stages ofdrugdiscoveryanddevelopment LeaddiscoveryandAnalogBased DrugDesign

Rationalapproachestoleaddiscovery basedontraditionalmedicine,Random

screening, Non-random screening, serendipitous drug discovery,leaddiscoverybasedondrugmetabolism,leaddiscoverybasedoncli nicalobservation.

Analog BasedDrug

Design:Bioisosterism,Classification,Bioisostericreplacement. Anythreecasestudies

UNIT-II 10Hours

QuantitativeStructureActivityRelationship(QSAR) SARversusQSAR,HistoryanddevelopmentofQSAR,Typesofphysicochemi cal parameters, experimental and theoretical approaches forthe

determination ofphysicochemical parameters such as Partitioncoefficient,

Hammet’ssubstituent constant and Tafts steric constant.Hanschanalysis,FreeWilsonanalysis,3D- QSARapproacheslikeCOMFAandCOMSIA.

UNIT-III 10Hours

MolecularModelingandvirtualscreeningtechniques VirtualScreeningtechniques:Druglikenessscreening,Conceptofpharm acophoremappingandpharmacophorebasedScreening,

Moleculardocking:Rigiddocking,flexibledocking,manualdocking,Docking based screening.Denovo drugdesign.

UNIT-IV 08Hours

Informatics&Methodsindrugdesign IntroductiontoBioinformatics,chemoinformatics.ADMEdatabases,chemic al,biochemicalandpharmaceuticaldatabases.

UNIT-V 07Hours

Molecular Modeling: Introduction to molecular mechanics and quantummechanics.Energy Minimization methods and Conformational Analysis,global conformational minimadetermination.

Recommended Books(LatestEditions)

1. RobertGCK, ed.,“DrugAction at theMolecularLevel”UniversityPrak PressBaltimore.

2. MartinYC.“QuantitativeDrugDesign”Dekker,NewYork.

3. DelgadoJN,RemersWAeds“Wilson&Gisvolds’sTextBookofOrganicMedicinal&P harmaceuticalChemistry”Lippincott,NewYork.

4. Foye WO“Principles ofMedicinalchemistry‘Lea&Febiger.

5. KorolkovasA,BurckhalterJH.“EssentialsofMedicinalChemistry”WileyInterscience

   .

6. Wolf ME, ed “The Basis of Medicinal Chemistry, Burger’s Medicinal Chemistry”JohnWiley&Sons,NewYork.

7. PatrickGraham,L.,AnIntroductiontoMedicinalChemistry,OxfordUniversityPress.

8. SmithHJ,WilliamsH,eds,“IntroductiontotheprinciplesofDrugDesign”WrightBosto n.

9. SilvermanR.B.“TheorganicChemistryofDrugDesignandDrugAction”AcademicPre ss NewYork.

   BP808ET:CELLANDMOLECULARBIOLOGY(Elective subject)

   45Hours

   
   

   Scope:

   • Cellbiology isabranchof biology thatstudies cells –their physiologicalproperties,theirstructure,the organelles theycontain,interactionswiththeirenvironment,theirlifecycle,division,deathand cellfunction.

   • Thisisdonebothonamicroscopicandmolecularlevel.

   • Cell biologyresearchencompassesboththegreatdiversityofsingle- celledorganismslike bacteria and protozoa,aswellasthemany specializedcellsinmulti-cellularorganismssuchas humans,plants,andsponges.

     
     

     Objectives:Upon completionofthesubjectstudentshallbeableto;

   • Summarize cellandmolecularbiologyhistory.

   • Summarizecellularfunctioningandcomposition.

   • Describethechemicalfoundationsofcellbiology.

   • SummarizetheDNApropertiesofcellbiology.

   • Describeproteinstructureandfunction.

   • Describecellularmembranestructureandfunction.

   • Describebasicmoleculargeneticmechanisms.

   • SummarizetheCellCycle

Coursecontent:

UnitI 10Hours

1. CellandMolecularBiology:DefinitionstheoryandbasicsandApplications.

2. CellandMolecular Biology:HistoryandSummation.

3. Propertiesofcellsandcellmembrane.

4. ProkaryoticversusEukaryotic

5. CellularReproduction

6. ChemicalFoundations–anIntroductionandReactions(Types)

UnitII 10Hours

1. DNA andtheFlowofMolecularInformation

2. DNAFunctioning

3. DNAandRNA

4. TypesofRNA

5. TranscriptionandTranslation

UnitIII 10Hours

1. Proteins: DefinedandAminoAcids

2. ProteinStructure

3. RegularitiesinProteinPathways

4. CellularProcesses

5. PositiveControlandsignificanceofProteinSynthesis

UnitIV 08Hours

1. ScienceofGenetics

2. TransgenicsandGenomicAnalysis

3. CellCycleanalysis

4. MitosisandMeiosis

5. CellularActivitiesandCheckpoints

UnitV 07Hours

1. CellSignals:Introduction

2. ReceptorsforCellSignals

3. SignalingPathways:Overview

4. MisregulationofSignalingPathways

5. Protein-Kinases:Functioning

RecommendedBooks(latestedition):

1. W.B.HugoandA.D.Russel:PharmaceuticalMicrobiology,BlackwellScientificpubl ications,OxfordLondon.

2. PrescottandDunn.,IndustrialMicrobiology,4thedition,CBSPublishers&Distr ibutors,Delhi.

3. Pelczar,ChanKreig,Microbiology,TataMcGrawHilledn.

4. MalcolmHarris,BalliereTindallandCox:PharmaceuticalMicrobiology.

5. Rose:IndustrialMicrobiology.

6. Probisher,Hinsdilletal:FundamentalsofMicrobiology,9thed.Japan

7. CooperandGunn’s:TutorialPharmacy,CBSPublisherandDistribution.

8. Peppler:MicrobialTechnology.

9. Edward:FundamentalsofMicrobiology.

10. N.K.Jain:PharmaceuticalMicrobiology,VallabhPrakashan,Delhi

11. Bergeys manual of systematic bacteriology, Williams and Wilkins- A Waverlycompany

12. B.R. Glick and J.J. Pasternak: Molecular Biotechnology: Principles andApplicationsofRecombinantDNA: ASMPress WashingtonD.C.

13. RAGoldshyet.al.,:KubyImmunology.

BP809ET.COSMETICSCIENCE(Theory)

45Hours

UNITI 10Hours

Classificationofcosmeticandcosmeceuticalproducts DefinitionofcosmeticsasperIndianandEUregulations,Evolutionofcosmeceuticalsfromcosm etics,cosmetics as quasiandOTC drugs

Cosmetic excipients: Surfactants, rheology modifiers, humectants, emollients,preservatives.Classification andapplication Skin:Basicstructureandfunctionofskin.

Hair:Basicstructureofhair.Hairgrowthcycle. OralCavity:Commonproblemassociatedwithteethandgums.

UNITII 10Hours

Principlesof formulationandbuildingblocksofskincareproducts:

Facewash, Moisturizingcream,ColdCream,Vanishingcreamandtheiradvantagesanddisadvantages.Appl ication of these products in formulation of cosmecuticals.Antiperspants&deodorants- Actives&mechanismofaction.

Principlesof formulationandbuildingblocksofHaircareproducts: Conditioningshampoo,Hairconditioner,anti- dandruffshampoo.Hairoils.

Chemistry and formulation of Para-phylene diamine based hair dye.Principles of formulation and building blocks of oral care products:Toothpasteforbleedinggums,sensitiveteeth.Teethwhitening,Mouthw ash.

UNITIII 10Hours

Sunprotection,ClassificationofSunscreens andSPF.

Roleofherbsin cosmetics:

Skin Care:Aloe and turmericHaircare:Hennaand amla.

Oralcare:Neemandclove

Analyticalcosmetics:BIS specificationandanalyticalmethodsforshampoo,skin- creamandtoothpaste.

UNITIV 08Hours.

PrinciplesofCosmeticEvaluation:Principlesofsebumeter,corneometer.MeasurementofTEW L,Skin Color,Hairtensilestrength,Haircombingproperties Soaps,andsyndetbars.Evolutionandskinbenfits.

UNITV 07Hours

Oilyand dryskin,causesleadingtodryskin, skinmoisturisation.Basic understandingoftheterms Comedogenic,dermatitis.

Cosmetic problems associated with Hair and scalp: Dandruff, Hair fall causesCosmeticproblemsassociatedwithskin:blemishes,wrinkles,acne,pricklyheatandb odyodor.

AntiperspirantsandDeodorants-Activesandmechanismofaction

References

1. Harry’sCosmeticology,Wilkinson,Moore,SeventhEdition,George Godwin.

2. Cosmetics– Formulations,ManufacturingandQualityControl,P.P.Sharma,4thEdition,VandanaPub lications Pvt.Ltd., Delhi.

3. Text bookof cosmelicologybySanju Nanda&RoopK. Khar, TataPublishers.

   BP810ET.EXPERIMENTAL PHARMACOLOGY (PHARMACOLOGICALSCREENINGMETHODS)

   45Hours

   
   

   Scope:Thissubjectisdesignedtoimpartthebasicknowledgeofpreclinicalstudiesinexperimentalanimals includingdesign,conductandinterpretationsofresults.

   
   

   Objectives

   Uponcompletionofthecoursethestudentshallbeableto,

   • Appreciatetheapplications ofvarious commonlyusedlaboratoryanimals.

   • Appreciateanddemonstrate

     thevariousscreeningmethodsusedinpreclinicalresearc

     h

   • Appreciateanddemonstratetheimportanceofbiostatisticsandresearchmethodology

   • Designandexecutearesearch hypothesisindependently

RecommendedBooks(latestedition):

1. FundamentalsofexperimentalPharmacology-byM.N.Ghosh

2. HandbookofExperimentalPharmacology-S.K.Kulakarni

3. CPCSEAguidelinesforlaboratoryanimalfacility.

4. DrugdiscoveryandEvaluationbyVogelH.G.

5. DrugScreeningMethodsbySureshKumar GuptaandS. K. Gupta

6. IntroductiontobiostatisticsandresearchmethodsbyPSSSundarRaoandJRichard

   BP811ET. ADVANCEDINSTRUMENTATIONTECHNIQUES

   45Hours

   
   

   Scope: This subject deals with the application of instrumental methods in qualitative andquantitative analysis of drugs. This subject is designed to impart advanced knowledge ontheprinciplesandinstrumentationofspectroscopicandchromatographichyphenatedtechniq ues.Thisalsoemphasizesontheoreticalandpracticalknowledgeonmodernanalyticalinstrument s that areusedfordrugtesting.

   
   

   Objectives:Upon completionofthecoursethestudentshallbeableto

   • understandtheadvancedinstrumentsusedanditsapplicationsindruganalysis

   • understandthechromatographicseparationandanalysisofdrugs.

   • understandthecalibrationofvariousanalyticalinstruments

   • knowanalysisof drugsusingvariousanalyticalinstruments.

CourseContent:

UNIT-I 10Hours

NuclearMagneticResonancespectroscopy

Principles of H-NMR and C-NMR, chemical shift, factors affecting chemicalshift, coupling constant, Spin - spin coupling, relaxation, instrumentation andapplications

MassSpectrometry-Principles,Fragmentation,Ionizationtechniques– Electronimpact,chemicalionization,MALDI,FAB,Analyzers- TimeofflightandQuadrupole,instrumentation, applications

UNIT-II 10Hours

ThermalMethods ofAnalysis: Principles, instrumentationand applicationsof ThermogravimetricAnalysis (TGA), Differential Thermal Analysis (DTA),Differential ScanningCalorimetry(DSC)

1. Ray Diffraction Methods: Origin of X-rays, basic aspects of crystals, X- ray

   Crystallography, rotating crystal technique, single crystal diffraction,powderdiffraction,structural elucidationandapplications.

   
   

   UNIT-III 10Hours

   Calibrationandvalidation-asperICHandUSFDAguidelines CalibrationoffollowingInstruments

   
   

   Electronicbalance,UV-Visiblespectrophotometer,IRspectrophotometer,

   Fluorimeter,FlamePhotometer,HPLCandGC

   
   

   UNIT-IV 08Hours

   Radio immune assay:Importance, various components, Principle, differentmethods,Limitation andApplicationsofRadioimmuno assay Extractiontechniques:Generalprincipleandprocedureinvolvedinthesolidphaseextr action andliquid-liquidextraction

   
   

   UNIT-V 07Hours

   Hyphenatedtechniques-LC-MS/MS,GC-MS/MS,HPTLC-MS.

   
   

   RecommendedBooks(LatestEditions)

   1. InstrumentalMethodsofChemicalAnalysis byB.KSharma

   2. Organic spectroscopybyY.RSharma

   3. TextbookofPharmaceutical Analysis byKennethA.Connors

   4. Vogel’sTextbookofQuantitativeChemicalAnalysisbyA.I.Vogel

   5. Practical PharmaceuticalChemistrybyA.H.BeckettandJ.B.Stenlake

   6. OrganicChemistrybyI.L.Finar

   7. Organic spectroscopybyWilliamKemp

   8. QuantitativeAnalysisofDrugsbyD.C.Garrett

   9. Quantitative Analysisof Drugs in PharmaceuticalFormulationsbyP.D. Sethi

   10. Spectrophotometric identification of OrganicCompoundsbySilverstein

BP812ET.DIETARYSUPPLEMENTSANDNUTRACEUTICALS

No.ofhours:3 Tutorial:1 Credit point:4Scope:

Thissubjectcoversfoundationaltopicthatareimportantforunderstandingtheneedandrequirementso fdietarysupplementsamongdifferent groupsinthepopulation.

Objective:

This module aims to provide an understanding of the concepts behind the theoreticalapplicationsofdietarysupplements.Bytheendofthecourse,studentsshouldbe ableto:

1. Understandtheneedofsupplementsbythedifferentgroupofpeopletomaintainhealthy life.

2. Understandtheoutcomeofdeficienciesindietarysupplements.

3. Appreciatethecomponentsindietarysupplementsandtheapplication.

4. Appreciatetheregulatoryand commercialaspectsofdietarysupplementsincludinghealthclaims.

   UNITI 07 hours

   1. Definitions of Functional foods, Nutraceuticals and Dietary supplements. Classificationof Nutraceuticals, Health problems and diseases that can be prevented or cured byNutraceuticals i.e. weight control, diabetes, cancer, heart disease, stress, osteoarthritis,hypertensionetc.

   2. Public health nutrition, maternal and child nutrition, nutrition and ageing, nutritioneducationincommunity.

   3. Source, Name of marker compounds and their chemical nature, Medicinal uses andhealthbenefitsoffollowingusedasnutraceuticals/functionalfoods:Spirulina,Soyabean, Ginseng, Garlic, Broccoli,Gingko,Flaxseeds

UNITII 15 hours

Phytochemicalsasnutraceuticals:Occurrenceandcharacteristicfeatures(chemicalnaturemedicinal benefits)offollowing

1. Carotenoids-αandβ-Carotene,Lycopene,Xanthophylls,leutin

2. Sulfides:Diallylsulfides,Allyltrisulfide.

3. Polyphenolics:Reservetrol

4. Flavonoids-Rutin,Naringin,Quercitin,Anthocyanidins,catechins,Flavones

5. Prebiotics/Probiotics.:Fructooligosaccharides,Lactobacillum

6. Phytoestrogens:Isoflavones,daidzein,Geebustin,lignans

7. Tocopherols

8. Proteins,vitamins, minerals,cereal, vegetablesandbeveragesasfunctionalfoods: oats,wheatbran,ricebran, sea foods, coffee,teaandthelike.

UNITIII 07 hours

1. Introduction to free radicals: Free radicals, reactive oxygen species, production of freeradicalsincells,damagingreactionsoffreeradicalsonlipids,proteins,Carbohydrates,nu cleicacids.

2. Dietaryfibresandcomplexcarbohydrates asfunctionalfoodingredients..

UNITIV 10 hours

1. FreeradicalsinDiabetesmellitus, Inflammation, Ischemicreperfusioninjury,Cancer,Atherosclerosis, Free radicals in brain metabolism and pathology, kidney damage,muscle damage. Free radicals involvement in other disorders. Free radicals theory ofageing.

2. Antioxidants: Endogenous antioxidants – enzymatic and nonenzymatic antioxidantdefence,Superoxidedismutase,catalase,Glutathioneperoxidase,GlutathioneV itaminC,VitaminE,α-Lipoicacid,melatonin Syntheticantioxidants:ButylatedhydroxyToluene,ButylatedhydroxyAnisole.

3. Functionalfoodsforchronicdiseaseprevention

UNITV 06 hours

1. Effectofprocessing,storageandinteractionsofvariousenvironmentalfactorsonthepotentialofnut raceuticals.

2. RegulatoryAspects;FSSAI,FDA,FPO,MPO,AGMARK.HACCPandGMPsonFoodSafety.Ad ulterationoffoods.

   
   

3. PharmacopoeialSpecificationsfordietarysupplementsandnutraceuticals.

   
   

   References:

   
   

   1. DieteticsbySriLakshmi

   2. RoleofdietaryfibresandneutraceuticalsinpreventingdiseasesbyK.TAgustiandP.Faizal:BS Punblication.

   3. Advanced NutritionalTherapiesbyCooper.K.A., (1996).

   4. TheFoodPharmacybyJeanCarper,Simon&Schuster,UKLtd.,(1988).

   5. PrescriptionforNutritionalHealingbyJamesF.BalchandPhyllisA.Balch2ndEdn.,AveryPubl ishingGroup,NY(1997).

   6. G.GibsonandC.williamsEditors 2000FunctionalfoodsWoodheadPubl.Co.London.

   7. Goldberg,I.FunctionalFoods.1994.ChapmanandHall,New York.

   8. Labuza,T.P.2000FunctionalFoodsandDietarySupplements:Safety,GoodManufacturing Practice(GMPs) and Shelf Life Testing inEssentials of FunctionalFoods M.K.Sachmidland T.P.Labuzaeds.AspenPress.

   9. HandbookofNutraceuticalsandFunctionalFoods,ThirdEdition(ModernNutrition)

   10. Shils, ME, Olson, JA, Shike, M. 1994 Modern Nutrition in Health and Disease.Eighthedition.LeaandFebiger

       SemesterVIII–Elective course on PharmaceuticalProductDevelopmentNoofHours:3 Tutorial:1

       Creditpoints:4

       Unit-I 10Hours

       Introduction to pharmaceutical product development, objectives, regulations related topreformulation,formulationdevelopment,stabilityassessment,manufacturingandqual itycontroltestingofdifferent types ofdosageforms

       
       

       Unit-II 10Hours

       Anadvancedstudy ofPharmaceuticalExcipientsinpharmaceuticalproductdevelopmentwithaspecialreferenceto thefollowingcategories

       1. Solventsandsolubilizers

       2. Cyclodextrinsandtheirapplications

       3. Non-ionicsurfactantsandtheirapplications

       4. Polyethyleneglycolsandsorbitols

       5. Suspendingandemulsifyingagents

       6. Semisolidexcipients

Unit-III 10Hours

AnadvancedstudyofPharmaceuticalExcipientsinpharmaceuticalproductdevelopmentw ithaspecial referencetothefollowingcategories

1. Tabletandcapsuleexcipients

2. Directlycompressiblevehicles

3. Coatmaterials

4. Excipientsinparenteralandaerosolsproducts

5. ExcipientsforformulationofNDDS Selectionandapplicationofexcipientsinpharmaceuticalformulationswithspecificindustr ialapplications

Unit-IV 08Hours

Optimizationtechniquesinpharmaceuticalproductdevelopment.Astudy ofvariousoptimizationtechniquesforpharmaceuticalproductdevelopmentwithspecifice xamples.Optimization by factorial designs and their applications.A study of QbD and itsapplicationinpharmaceutical productdevelopment.

Unit-V 07Hours

Selectionandqualitycontroltestingofpackagingmaterialsforpharmaceuticalproductdev elopment-regulatoryconsiderations.