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rgpv syllabus BPharm(PCI) Grading System 7th Semester Microsoft Word - B. Pharm Sem. VII Syllabus
SEMESTER VII
BP701T.INSTRUMENTALMETHODSOFANALYSIS(Theory)
45Hours
Scope: This subject deals with the application of instrumental methods in qualitative andquantitativeanalysisofdrugs.Thissubjectisdesignedtoimpartafundamentalknowledge on the principles and instrumentation of spectroscopic and chromatographictechnique.Thisalsoemphasizesontheoreticalandpracticalknowledgeonmod ernanalyticalinstruments that areusedfordrugtesting.
Theory, Concepts of singlet, doublet and triplet electronic states, internal and externalconversions,factorsaffectingfluorescence,quenching,instrumentationandapplica tions
Regulatory affairs: Introduction, Historical overview of Regulatory Affairs, Regulatoryauthorities, Role of Regulatory affairs department, Responsibility of Regulatory AffairsProfessionals
Regulatory requirements for drug approval: Drug Development Teams, Non- ClinicalDrugDevelopment,Pharmacology,DrugMetabolismandToxicology,Generalconside rations of Investigational New Drug (IND) Application, Investigator’s Brochure(IB) and New Drug Application (NDA), Clinical research / BE studies, Clinical ResearchProtocols, Biostatistics in Pharmaceutical Product Development, Data Presentation forFDASubmissions,Management ofClinicalStudies.
Scope: In the changing scenario of pharmacy practice in India, for successful practice ofHospital Pharmacy, the students are required to learn various skills like drug distribution,druginformation,andtherapeuticdrugmonitoringforimprovedpatientcare.Incom munity pharmacy,studentswillbelearningvariousskillssuchasdispensingofdrugs,respondingtominor ailmentsbyprovidingsuitablesafemedication,patientcounsellingfor improvedpatient carein thecommunityset up.
Definition,Classificationofhospital- Primary,SecondaryandTertiaryhospitals,Classification based on clinical and non- clinical basis, Organization Structure of aHospital,andMedicalstaffs involvedinthehospitalandtheirfunctions.
Hospitalpharmacyanditsorganization
Definition, functions of hospital pharmacy, Organization structure, Location, Layoutandstaffrequirements,andResponsibilitiesandfunctionsofhospitalpharmacists.
drug interactions, spontaneous case reports and record linkage studies, and Adversedrugreactionreportingand management.
Community Pharmacy
Organization and structure of retail and wholesale drug store, types and design, Legalrequirementsforestablishmentandmaintenanceofadrugstore,Dispensingofproprieta ryproducts, maintenanceof records ofretailandwholesaledrugstore.
Definition, contents of hospital formulary, Differentiation of hospital formulary andDrug list, preparation and revision, and addition and deletion of drug from hospitalformulary.
Educationandtrainingprogramin thehospital Roleofpharmacistintheeducationandtrainingprogram,Internalandexternaltraining program, Services to the nursing homes/clinics, Code of ethics for communitypharmacy,andRoleofpharmacistintheinterdepartmentalcommunicationandco mmunityhealth education.
Organisation of drug store, types of materials stocked and storage conditions, Purchaseand inventory control:principles, purchase procedure, purchase order,procurementand stocking, Economic order quantity, Reorder quantity level, and Methods used fortheanalysisofthedrugexpenditure
To understand various approachesfordevelopmentofnovel drugdeliverysystems.
To understand the criteria for selection of drugs and polymers for the development ofNovel drugdeliverysystems, theirformulation and evaluation
Coursecontent:
Unit-I 10Hours
Controlled drug delivery systems: Introduction, terminology/definitions and rationale,advantages, disadvantages, selection of drug candidates.Approaches to design controlledreleaseformulationsbasedondiffusion,dissolutionandionexchangeprinciples.Phys icochemicalandbiologicalpropertiesofdrugsrelevanttocontrolledreleaseformulations
Transdermal Drug Delivery Systems:Introduction, Permeation through skin, factorsaffecting permeation,permeationenhancers,basic componentsof TDDS,formulationapproaches
Gastroretentivedrugdeliverysystems:Introduction,advantages,disadvantages,approaches for GRDDS – Floating, high density systems, inflatable and gastroadhesivesystemsandtheirapplications
Nasopulmonary drug delivery system: Introduction to Nasal and Pulmonary routes ofdrug delivery,FormulationofInhalers(dry powder andmetereddose),nasalsprays,nebulizers
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rgpv syllabus BPharm(PCI) Grading System 7th Semester Microsoft Word - B. Pharm Sem. VII Syllabus
SEMESTER VII
BP701T.INSTRUMENTALMETHODSOFANALYSIS(Theory)
45Hours
Scope: This subject deals with the application of instrumental methods in qualitative andquantitativeanalysisofdrugs.Thissubjectisdesignedtoimpartafundamentalknowledge on the principles and instrumentation of spectroscopic and chromatographictechnique.Thisalsoemphasizesontheoreticalandpracticalknowledgeonmod ernanalyticalinstruments that areusedfordrugtesting.
Theory, Concepts of singlet, doublet and triplet electronic states, internal and externalconversions,factorsaffectingfluorescence,quenching,instrumentationandapplica tions
Regulatory affairs: Introduction, Historical overview of Regulatory Affairs, Regulatoryauthorities, Role of Regulatory affairs department, Responsibility of Regulatory AffairsProfessionals
Regulatory requirements for drug approval: Drug Development Teams, Non- ClinicalDrugDevelopment,Pharmacology,DrugMetabolismandToxicology,Generalconside rations of Investigational New Drug (IND) Application, Investigator’s Brochure(IB) and New Drug Application (NDA), Clinical research / BE studies, Clinical ResearchProtocols, Biostatistics in Pharmaceutical Product Development, Data Presentation forFDASubmissions,Management ofClinicalStudies.
Scope: In the changing scenario of pharmacy practice in India, for successful practice ofHospital Pharmacy, the students are required to learn various skills like drug distribution,druginformation,andtherapeuticdrugmonitoringforimprovedpatientcare.Incom munity pharmacy,studentswillbelearningvariousskillssuchasdispensingofdrugs,respondingtominor ailmentsbyprovidingsuitablesafemedication,patientcounsellingfor improvedpatient carein thecommunityset up.
Definition,Classificationofhospital- Primary,SecondaryandTertiaryhospitals,Classification based on clinical and non- clinical basis, Organization Structure of aHospital,andMedicalstaffs involvedinthehospitalandtheirfunctions.
Hospitalpharmacyanditsorganization
Definition, functions of hospital pharmacy, Organization structure, Location, Layoutandstaffrequirements,andResponsibilitiesandfunctionsofhospitalpharmacists.
drug interactions, spontaneous case reports and record linkage studies, and Adversedrugreactionreportingand management.
Community Pharmacy
Organization and structure of retail and wholesale drug store, types and design, Legalrequirementsforestablishmentandmaintenanceofadrugstore,Dispensingofproprieta ryproducts, maintenanceof records ofretailandwholesaledrugstore.
Definition, contents of hospital formulary, Differentiation of hospital formulary andDrug list, preparation and revision, and addition and deletion of drug from hospitalformulary.
Educationandtrainingprogramin thehospital Roleofpharmacistintheeducationandtrainingprogram,Internalandexternaltraining program, Services to the nursing homes/clinics, Code of ethics for communitypharmacy,andRoleofpharmacistintheinterdepartmentalcommunicationandco mmunityhealth education.
Organisation of drug store, types of materials stocked and storage conditions, Purchaseand inventory control:principles, purchase procedure, purchase order,procurementand stocking, Economic order quantity, Reorder quantity level, and Methods used fortheanalysisofthedrugexpenditure
To understand various approachesfordevelopmentofnovel drugdeliverysystems.
To understand the criteria for selection of drugs and polymers for the development ofNovel drugdeliverysystems, theirformulation and evaluation
Coursecontent:
Unit-I 10Hours
Controlled drug delivery systems: Introduction, terminology/definitions and rationale,advantages, disadvantages, selection of drug candidates.Approaches to design controlledreleaseformulationsbasedondiffusion,dissolutionandionexchangeprinciples.Phys icochemicalandbiologicalpropertiesofdrugsrelevanttocontrolledreleaseformulations
Transdermal Drug Delivery Systems:Introduction, Permeation through skin, factorsaffecting permeation,permeationenhancers,basic componentsof TDDS,formulationapproaches
Gastroretentivedrugdeliverysystems:Introduction,advantages,disadvantages,approaches for GRDDS – Floating, high density systems, inflatable and gastroadhesivesystemsandtheirapplications
Nasopulmonary drug delivery system: Introduction to Nasal and Pulmonary routes ofdrug delivery,FormulationofInhalers(dry powder andmetereddose),nasalsprays,nebulizers