Experimental studies, SPSS, R and MINITAB statistical software’s, analyzing the statistical data using Excel.
®
Know the operation of M.S. Excel, SPSS, R and MINITAB , DoE (Design of Experiment)
Know the various statistical techniques to solve statistical problems Appreciate statistical techniques in solving the problems.
- Pharmaceuticals examples
Sample, Population, large sample, small sample, Null hypothesis, alternative hypothesis, sampling, essence of sampling, types of sampling, Error-I type, Error-II type, Standard error of mean (SEM) - Pharmaceutical examples
Blocking and confounding system for Two-level factorials
®
Statistical Analysis Using Excel, SPSS, MINITAB , DESIGN OF EXPERIMENTS, R -
Online Statistical Software’s to Industrial and Clinical trial approach
Factorial Design: Definition, 22, 23design. Advantage of factorial design
Pharmaceutical statistics- Practical and clinical applications, Sanford Bolton, publisher Marcel Dekker Inc. NewYork.
Fundamental of Statistics – Himalaya Publishing House- S.C.Guptha
Design and Analysis of Experiments –PHI Learning Private Limited, R. Pannerselvam,
Design and Analysis of Experiments – Wiley Students Edition,
Douglas and C. Montgomery
The purpose of this course is to introduce to students a number of health issues and their challenges. This course also introduced a number of national health programmes. The roles of the pharmacist in these contexts are also discussed.
After the successful completion of this course, the student shall be able to:
Acquire high consciousness/realization of current issuesrelated to health and pharmaceutical problems within the country and worldwide.
Have a critical way of thinking based on current healthcare development. Evaluate alternative ways of solving problems related tohealth and pharmaceutical issues
programme for prevention and control of deafness, Universal immunization programme, National programme for control of blindness, Pulse polio programme.
National health intervention programme for mother and child, National family welfare programme, National tobacco control programme, National Malaria Prevention Program, National programme for the health care for the elderly, Social health programme; role of WHO in Indian national program
Community services in rural, urban and school health: Functions of PHC, Improvement in rural sanitation, national urban health mission, Health promotion and education in school.
Short Textbook of Preventive and Social Medicine, Prabhakara GN, 2nd Edition, 2010, ISBN: 9789380704104, JAYPEE Publications
Textbook of Preventive and Social Medicine (Mahajan and Gupta), Edited by Roy
th
Rabindra Nath, Saha Indranil, 4 Edition, 2013, ISBN: 9789350901878, JAYPEE Publications
Review of Preventive and Social Medicine (Including Biostatistics), Jain Vivek, 6th
Edition, 2014, ISBN: 9789351522331, JAYPEE Publications
Essentials of Community Medicine—A Practical Approach, Hiremath Lalita D, Hiremath Dhananjaya A, 2nd Edition, 2012, ISBN: 9789350250440, JAYPEE Publications
Park Textbook of Preventive and Social Medicine, K Park, 21st
Edition, 2011,
ISBN-14: 9788190128285, BANARSIDAS BHANOT PUBLISHERS.
Community Pharmacy Practice, Ramesh Adepu, BSP publishers, Hyderabad
1. Research in Social and Administrative Pharmacy, Elsevier, Ireland
The pharmaceutical industry not only needs highly qualified researchers, chemists and, technical people, but also requires skilled managers who can take the industry forward by managing and taking the complex decisions which are imperative for the growth of the industry. The Knowledge and Know-how of marketing management groom the people for taking a challenging role in Sales and Product management.
Definition, general concepts and scope of marketing; Distinction between marketing & selling; Marketing environment; Industry and competitive analysis; Analyzing consumer buying behavior; industrial buying behavior.
Quantitative and qualitative aspects; size and composition of the market; demographic descriptions and socio-psychological characteristics of the consumer; market segmentation& targeting.Consumer profile; Motivation and prescribing habits of the physician; patients' choice of physician and retail pharmacist.Analyzing the Market;Role of market research.
Classification, product line and product mix decisions, product life cycle,product portfolio analysis; product positioning; New product decisions; Product branding, packaging and labeling decisions, Product management in pharmaceutical industry.
Methods, determinants of promotional mix, promotional budget; An overview of personal selling, advertising, direct mail, journals, sampling, retailing, medical exhibition, public relations, online promotional techniques for OTC Products.
Designing channel, channel members, selecting the appropriate channel, conflict in channels, physical distribution management: Strategic importance, tasks in physical distribution management.
Duties of PSR, purpose of detailing, selection and training, supervising, norms for customer calls, motivating, evaluating, compensation and future prospects of the PSR.
Meaning, importance, objectives, determinants of price; pricing methods and strategies, issues in price management in pharmaceutical industry. An overview of DPCO (Drug Price Control Order)and NPPA (National Pharmaceutical Pricing Authority).
Vertical & Horizontal Marketing; RuralMarketing; Consumerism; Industrial Marketing; Global Marketing.
Philip Kotler and Kevin Lane Keller: Marketing Management, Prentice Hall of India, New Delhi
Walker, Boyd and Larreche : Marketing Strategy- Planning and Implementation, Tata MC GrawHill, New Delhi.
Dhruv Grewal and Michael Levy: Marketing, Tata MC Graw Hill
Arun Kumar and N Menakshi: Marketing Management, Vikas Publishing, India Rajan Saxena: Marketing Management; Tata MC Graw-Hill (India Edition) Ramaswamy, U.S & Nanakamari, S: Marketing Managemnt:Global Perspective, IndianContext,Macmilan India, New Delhi.
Shanker, Ravi: Service Marketing, Excell Books, New Delhi
Subba Rao Changanti, Pharmaceutical Marketing in India (GIFT – Excel series) Excel Publications.
know the regulatory approval process and their registration in Indian and international markets
appreciate EU and ICH guidelines for quality control of herbal drugs
Basic tests for drugs – Pharmaceutical substances, Medicinal plants materials and dosage forms
WHO guidelines for quality control of herbal drugs. Evaluation of commercial crude drugs intended for use
WHO Guidelines on current good manufacturing Practices (cGMP) for Herbal Medicines WHO Guidelines on GACP for Medicinal Plants.
EU and ICH guidelines for quality control of herbal drugs.
Research Guidelines for Evaluating the Safety and Efficacy of Herbal Medicines
Stability testing of herbal medicines.Application of various chromatographic techniques in standardization of herbal products.
Preparation of documents for new drug application and export registration GMP requirements and Drugs & Cosmetics Act provisions.
Regulatory requirements for herbal medicines.
WHO guidelines on safety monitoring of herbal medicines in pharmacovigilance systems Comparison of various Herbal Pharmacopoeias.
Role of chemical and biological markers in standardization of herbal products
Rangari, V.D., Text book of Pharmacognosy and Phytochemistry Vol. I , Carrier Pub., 2006.
Aggrawal, S.S., Herbal Drug Technology. Universities Press, 2002. EMEA. Guidelines on Quality of Herbal Medicinal Products/Traditional Medicinal Products,
Mukherjee, P.W. Quality Control of Herbal Drugs: An Approach to Evaluation of Botanicals. Business Horizons Publishers, New Delhi, India, 2002.
Shinde M.V., Dhalwal K., Potdar K., Mahadik K. Application of quality control principles to herbal drugs. International Journal of Phytomedicine 1(2009); p. 4-8. WHO. Quality Control Methods for Medicinal Plant Materials, World Health Organization, Geneva, 1998. WHO. Guidelines for the Appropriate Use of Herbal Medicines. WHO Regional Publications, Western Pacific Series No 3, WHO Regional office for the Western Pacific, Manila, 1998.
WHO. The International Pharmacopeia, Vol. 2: Quality Specifications, 3rd edn. World Health Organization, Geneva, 1981.
WHO. Quality Control Methods for Medicinal Plant Materials. World Health Organization, Geneva, 1999.
WHO. WHO Global Atlas of Traditional, Complementary and Alternative Medicine. 2 vol. set. Vol. 1 contains text and Vol. 2, maps. World Health Organization, Geneva, 2005.
WHO. Guidelines on Good Agricultural and Collection Practices (GACP) for Medicinal Plants. World Health Organization, Geneva, 2004.
Classification of cosmetic and cosmeceutical products
Definition of cosmetics as per Indian and EU regulations, Evolution of cosmeceuticals from cosmetics, cosmetics as quasi and OTC drugs
Face wash,
Moisturizing cream, Cold Cream, Vanishing cream and their advantages and disadvantages.Application of these products in formulation of cosmecuticals. Antiperspants & deodorants- Actives & mechanism of action.
Conditioning shampoo, Hair conditioner,anti-dandruff shampoo. Hair oils.
Chemistry and formulation of Para-phylene diamine based hair dye. Principles of formulation and building blocks of oral care products: Toothpaste for bleeding gums, sensitive teeth. Teeth whitening, Mouthwash.
Sun protection, Classification of Sunscreens and SPF.
Skin Care: Aloe and turmeric Hair care: Henna and amla.
Oral care: Neem and clove
Principles of Cosmetic Evaluation:Principles of sebumeter, corneometer. Measurement of TEWL, Skin Color, Hair tensile strength, Hair combing properties
Soaps,and syndet bars. Evolution and skin benfits.
Oily and dry skin, causes leading to dry skin, skin moisturisation. Basic understanding of the terms Comedogenic, dermatitis.
Cosmetic problems associated with Hair and scalp: Dandruff, Hair fall causes Cosmetic problems associated with skin: blemishes, wrinkles, acne, prickly heat and body odor.
Antiperspirants and Deodorants- Actives and mechanism of action
Harry’s Cosmeticology, Wilkinson, Moore, Seventh Edition, George Godwin. Cosmetics – Formulations, Manufacturing and Quality Control, P.P. Sharma, 4th Edition, Vandana Publications Pvt. Ltd., Delhi.
Text book of cosmelicology by Sanju Nanda & Roop K. Khar, Tata Publishers.
Upon completion of the course the student shall be able to,
Appreciate the applications of various commonly used laboratory animals.
Appreciate and demonstrate the various screening methods used in preclinical research
Appreciate and demonstrate the importance of biostatistics and researchmethodology Design and execute a research hypothesis independently
Study of CPCSEA and OECD guidelines for maintenance, breeding and conduct of experiments on laboratory animals, Common lab animals: Description and applications of different species and strains of animals. Popular transgenic and mutant animals.
Techniques for collection of blood and common routes of drug administration in laboratory animals, Techniques of blood collection and euthanasia.
a. Introduction: Dose selection, calculation and conversions, preparation of drug solution/suspensions, grouping of animals and importance of sham negative and positive control groups. Rationale for selection of animal species and sex for the study.
Diuretics, nootropics, anti-Parkinson’s,antiasthmatics, Preclinical screening models: for CNS activity- analgesic, antipyretic,anti-inflammatory, general anaesthetics, sedative and hypnotics, antipsychotic, antidepressant, antiepileptic, antiparkinsonism, alzheimer’s disease
Preclinical screening models for other important drugs like antiulcer, antidiabetic, anticancer and antiasthmatics.
Selection of research topic, review of literature, research hypothesis and study design
Pre-clinical data analysis and interpretation using Students ‘t’ test and One-way ANOVA. Graphical representation of data
Fundamentals of experimental Pharmacology-by M.N.Ghosh Hand book of Experimental Pharmacology-S.K.Kulakarni CPCSEA guidelines for laboratory animal facility.
Drug discovery and Evaluation by Vogel H.G.
Drug Screening Methods by Suresh Kumar Gupta and S. K. Gupta Introduction to biostatistics and research methods by PSS Sundar Rao and J Richard
understand the advanced instruments used and its applications in drug analysis understand the chromatographic separation and analysis of drugs.
understand the calibration of various analytical instruments know analysis of drugs using various analytical instruments.
Principles of H-NMR and C-NMR, chemical shift, factors affecting chemical shift, coupling constant, Spin - spin coupling, relaxation, instrumentation and applications
Crystallography, rotating crystal technique, single crystal diffraction,powder diffraction, structural elucidation and applications.
Electronic balance, UV-Visible spectrophotometer, IR spectrophotometer,
Fluorimeter, Flame Photometer, HPLC and GC
Instrumental Methods of Chemical Analysis by B.K Sharma Organic spectroscopy by Y.R Sharma
3. Text book of Pharmaceutical Analysis by Kenneth A. Connors Vogel’s Text book of Quantitative Chemical Analysis by A.I. Vogel Practical Pharmaceutical Chemistry by A.H. Beckett and J.B. Stenlake Organic Chemistry by I. L. Finar
Organic spectroscopy by William Kemp Quantitative Analysis of Drugs by D. C. Garrett
Quantitative Analysis of Drugs in Pharmaceutical Formulations by P. D. Sethi Spectrophotometric identification of Organic Compounds by Silver
Know the regulatory authorities and agencies governing the manufacture and sale of pharmaceuticals
Know the regulatory approval process and their registration in Indian and international markets
Stages of drug discovery, Drug development process, pre-clinical studies, non-clinical activities, clinical studies, Innovator and generics, Concept of generics, Generic drug product development.
Approval processes and timelines involved in Investigational New Drug (IND), New Drug Application (NDA), Abbreviated New Drug Application (ANDA). Changes to an approved NDA / ANDA.
Overview of regulatory authorities of India, United States, European Union, Australia, Japan, Canada (Organization structure and types of applications)
Procedure for export of pharmaceutical products, Technical documentation, Drug Master Files (DMF), Common Technical Document (CTD), electronic Common Technical
Document (eCTD), ASEAN Common Technical Document (ACTD)research.
Developing clinical trial protocols, Institutional Review Board / Independent Ethics committee - formation and working procedures, Informed consent process and procedures, GCP obligations of Investigators, sponsors & Monitors, Managing and Monitoring clinical trials, Pharmacovigilance - safety monitoring in clinical trials
Basic terminology, guidance, guidelines, regulations, Laws and Acts, Orange book, Federal Register, Code of Federal Regulatory, Purple book
Drug Regulatory Affairs by Sachin Itkar, Dr. N.S. Vyawahare, Nirali Prakashan. The Pharmaceutical Regulatory Process, Second Edition Edited by Ira R. Berry and Robert P. Martin, Drugs and the Pharmaceutical Sciences,Vol.185. Informa Health care Publishers.
New Drug Approval Process: Accelerating Global Registrations By Richard
th
A Guarino, MD, 5 edition, Drugs and the Pharmaceutical Sciences,Vol.190.
Guidebook for drug regulatory submissions / Sandy Weinberg. By John Wiley & Sons. Inc.
FDA Regulatory Affairs: a guide for prescription drugs, medical devices, and biologics /edited by Douglas J. Pisano, David Mantus.
Generic Drug Product Development, Solid Oral Dosage forms, Leon Shargel and Isader Kaufer, Marcel Dekker series, Vol.143
Clinical Trials and Human Research: A Practical Guide to Regulatory Compliance By Fay A. Rozovsky and Rodney K. Adams
Principles and Practices of Clinical Research, Second Edition Edited by John I. Gallin and Frederick P. Ognibene
Drugs: From Discovery to Approval, Second Edition By Rick
Scope: This paper will provide an opportunity for the student to learn about development of pharmacovigilance as a science, basic terminologies used in pharmacovigilance, global scenario of Pharmacovigilance, train students on establishing pharmacovigilance programme in an organization, various methods that can be used to generate safety data and signal detection. This paper also develops the skills of classifying drugs, diseases and adverse drug reactions.
Objectives:
At completion of this paper it is expected that students will be able to (know, do, and appreciate):
Why drug safety monitoring is important? History and development of pharmacovigilance
National and international scenario of pharmacovigilance Dictionaries, coding and terminologies used in pharmacovigilance Detection of new adverse drug reactions and their assessment International standards for classification of diseases and drugs
Adverse drug reaction reporting systems and communication in pharmacovigilance Methods to generate safety data during pre clinical, clinical and post approval phases of drugs’ life cycle
Drug safety evaluation in paediatrics, geriatrics, pregnancy and lactation Pharmacovigilance Program of India (PvPI) requirement for ADR reporting in India ICH guidelines for ICSR, PSUR, expedited reporting, pharmacovigilance planning CIOMS requirements for ADR reporting
Writing case narratives of adverse events and their quality.
Unit I
Introduction to Pharmacovigilance
History and development of Pharmacovigilance Importance of safety monitoring of Medicine WHO international drug monitoring programme Pharmacovigilance Program of India(PvPI)
Introduction to adverse drug reactions Definitions and classification of ADRs Detection and reporting
Methods in Causality assessment Severity and seriousness assessment
Predictability and preventability assessment Management of adverse drug reactions
Basic terminologies used in pharmacovigilance
Terminologies of adverse medication related events Regulatory terminologies
Unit II
Drug and disease classification
Anatomical, therapeutic and chemical classification of drugs International classification of diseases
Daily defined doses
International Non proprietary Names for drugs
Drug dictionaries and coding in pharmacovigilance WHO adverse reaction terminologies MedDRA and Standardised MedDRA queries WHO drug dictionary
Eudravigilance medicinal product dictionary
Information resources in pharmacovigilance Basic drug information resources Specialised resources for ADRs
Establishing pharmacovigilance programme
Establishing in a hospital
Establishment & operation of drug safety department in industry Contract Research Organisations (CROs)
Establishing a national programme
Unit III
Vaccine safety surveillance
Vaccine Pharmacovigilance Vaccination failure
Adverse events following immunization
Pharmacovigilance methods
Passive surveillance – Spontaneous reports and case series Stimulated reporting
Active surveillance – Sentinel sites, drug event monitoring and registries Comparative observational studies – Cross sectional study, case control study and cohort study
Targeted clinical investigations
Communication in pharmacovigilance
Effective communication in Pharmacovigilance Communication in Drug Safety Crisis management
Communicating with Regulatory Agencies, Business Partners, Healthcare facilities & Media
Unit IV
Safety data generation
1 Pre clinical phase
1 Clinical phase
1 Post approval phase (PMS)
ICH Guidelines for Pharmacovigilance
1 Organization and objectives of ICH
1 Expedited reporting
1 Individual case safety reports
1 Periodic safety update reports
1 Post approval expedited reporting
1 Pharmacovigilance planning
1 Good clinical practice in pharmacovigilance studie
Unit V
Pharmacogenomics of adverse drug reactions
Genetics related ADR with example focusing PK parameters.
Drug safety evaluation in special population
Paediatrics
Pregnancy and lactation Geriatrics
CIOMS
CIOMS Working Groups CIOMS Form
CDSCO (India) and Pharmacovigilance
D&C Act and Schedule Y
Differences in Indian and global pharmacovigilance requirements
Textbook of Pharmacovigilance: S K Gupta, Jaypee Brothers, Medical Publishers. Practical Drug Safety from A to Z By Barton Cobert, Pierre Biron, Jones and Bartlett Publishers.
Mann's Pharmacovigilance:Elizabeth B. Andrews, Nicholas, Wiley Publishers. Stephens' Detection of New Adverse Drug Reactions: John Talbot, Patrick Walle, Wiley Publishers.
An Introduction to Pharmacovigilance: Patrick Waller,Wiley Publishers. Cobert's Manual of Drug Safety and Pharmacovigilance: Barton Cobert,Jones& Bartlett Publishers.
Textbook of Pharmacoepidemiolog edited by Brian L. Strom, Stephen E Kimmel, Sean Hennessy,Wiley Publishers.
A Textbook of Clinical Pharmacy Practice -Essential Concepts and Skills:G. Parthasarathi, Karin NyfortHansen,Milap C. Nahata
National Formulary of India
Text Book of Medicine by Yashpal Munjal
Text book of Pharmacovigilance: concept and practice by GP Mohanta and PK Manna
Design and discovery of lead molecules
The role of drug design in drug discovery process The concept of QSAR and docking
Various strategies to develop new drug like molecules.
The design of new drug molecules using molecular modeling software
Stages of drug discovery and development
Rational approaches to lead discovery based on traditional medicine, Random screening, Non-random screening, serendipitous drug discovery, lead discovery based on drug metabolism, lead discovery based on clinical observation.
SAR versus QSAR, History and development of QSAR, Types of physicochemical parameters, experimental and theoretical approaches for the determination of physicochemical parameters such as Partition coefficient, Hammet’s substituent constant and Tafts steric constant. Hansch analysis, Free Wilson analysis, 3D-QSAR approaches like COMFA and COMSIA.
Molecular docking: Rigid docking, flexible docking, manual docking, Docking based screening. De novo drug design.
Introduction to Bioinformatics, chemoinformatics. ADME databases, chemical, biochemical and pharmaceutical databases.
Robert GCK, ed., “Drug Action at the Molecular Level” University Prak Press Baltimore.
Martin YC. “Quantitative Drug Design” Dekker, New York.
Delgado JN, Remers WA eds “Wilson & Gisvolds’s Text Book of Organic Medicinal & Pharmaceutical Chemistry” Lippincott, New York.
Foye WO “Principles of Medicinal chemistry ‘Lea & Febiger.
Koro lkovas A, Burckhalter JH. “Essentials of Medicinal Chemistry” Wiley Interscience.
Wolf ME, ed “The Basis of Medicinal Chemistry, Burger’s Medicinal Chemistry” John Wiley & Sons, New York.
Patrick Graham, L., An Introduction to Medicinal Chemistry, Oxford University Press.
Smith HJ, Williams H, eds, “Introduction to the principles of Drug Design” Wright Boston.
Silverman R.B. “The organic Chemistry of Drug Design and Drug Action” Academic Press New York.
Cell biology is a branch of biology that studies cells – their physiological properties, their structure, the organelles they contain, interactions with their environment, their life cycle, division, death and cell function.
This is done both on a microscopic and molecular level.
Cell biology research encompasses both the great diversity of single-celled organisms like bacteria and protozoa, as well as the many specialized cells in multi-cellular organismssuch as humans, plants, and sponges.
Summarize cellular functioning and composition. Describe the chemical foundations of cell biology. Summarize the DNA properties of cell biology.
Describe protein structure and function.
Describe cellular membrane structure and function. Describe basic molecular genetic mechanisms.
Summarize the Cell Cycle
Cell and Molecular Biology: Definitions theory and basics and Applications. Cell and Molecular Biology: History and Summation.
Properties of cells and cell membrane. Prokaryotic versus Eukaryotic Cellular Reproduction
Chemical Foundations – an Introduction and Reactions (Types)
DNA and the Flow of Molecular Information DNA Functioning
DNA and RNA Types of RNA
Transcription and Translation
Proteins: Defined and Amino Acids Protein Structure
Regularities in Protein Pathways Cellular Processes
Positive Control and significance of Protein Synthesis
Science of Genetics
Transgenics and Genomic Analysis Cell Cycle analysis
Mitosis and Meiosis
Cellular Activities and Checkpoints
Cell Signals: Introduction Receptors for Cell Signals Signaling Pathways: Overview
Misregulation of Signaling Pathways Protein-Kinases: Functioning
W.B. Hugo and A.D. Russel: Pharmaceutical Microbiology, Blackwell Scientific publications, Oxford London.
Prescott and Dunn., Industrial Microbiology, 4th edition, CBS Publishers
& Distributors, Delhi.
Pelczar, Chan Kreig, Microbiology, Tata McGraw Hill edn.
Malcolm Harris, Balliere Tindall and Cox: Pharmaceutical Microbiology. Rose: Industrial Microbiology.
Probisher, Hinsdill et al: Fundamentals of Microbiology, 9th ed. Japan Cooper and Gunn’s: Tutorial Pharmacy, CBS Publisher and Distribution. Peppler: Microbial Technology.
Edward: Fundamentals of Microbiology.
N.K.Jain: Pharmaceutical Microbiology, Vallabh Prakashan, Delhi
Bergeys manual of systematic bacteriology, Williams and Wilkins- A Waverly company
B.R. Glick and J.J. Pasternak: Molecular Biotechnology: Principles and Applications of RecombinantDNA: ASM Press Washington D.C.
RA Goldshy et. al., : Kuby Immunology.
This subject covers foundational topic that are important for understanding the need and requirements of dietary supplements among different groups in the population.
This module aims to provide an understanding of the concepts behind the theoretical applications of dietary supplements. By the end of the course, students should be able to :
Understand the need of supplements by the different group of people to maintain healthy life.
Understand the outcome of deficiencies in dietary supplements. Appreciate the components in dietary supplements and the application.
Appreciate the regulatory and commercial aspects of dietary supplements including health claims.
Definitions of Functional foods, Nutraceuticals and Dietary supplements. Classification of Nutraceuticals, Health problems and diseases that can be prevented or cured by Nutraceuticals i.e. weight control, diabetes, cancer, heart disease, stress, osteoarthritis, hypertension etc.
Public health nutrition, maternal and child nutrition, nutrition and ageing, nutrition education in community.
Source, Name of marker compounds and their chemical nature, Medicinal uses and
health benefits of following used as nutraceuticals/functional foods: Spirulina, Soyabean, Ginseng, Garlic, Broccoli, Gingko, Flaxseeds
Phytochemicals as nutraceuticals: Occurrence and characteristic features(chemical nature medicinal benefits) of following
Carotenoids- α and β-Carotene, Lycopene, Xanthophylls, leutin Sulfides: Diallyl sulfides, Allyl trisulfide.
Polyphenolics: Reservetrol
Flavonoids- Rutin , Naringin, Quercitin, Anthocyanidins, catechins, Flavones Prebiotics / Probiotics.: Fructo oligosaccharides, Lacto bacillum
Phyto estrogens : Isoflavones, daidzein, Geebustin, lignans Tocopherols
Proteins, vitamins, minerals, cereal, vegetables and beverages as functional foods: oats, wheat bran, rice bran, sea foods, coffee, tea and the like.
Introduction to free radicals: Free radicals, reactive oxygen species, production of free radicals in cells, damaging reactions of free radicals on lipids, proteins, Carbohydrates, nucleic acids.
b) Dietary fibres and complex carbohydrates as functional food ingredients..
Free radicals in Diabetes mellitus, Inflammation, Ischemic reperfusion injury, Cancer, Atherosclerosis, Free radicals in brain metabolism and pathology, kidney damage, muscle damage. Free radicals involvement in other disorders. Free radicals theory of ageing.
Antioxidants: Endogenous antioxidants – enzymatic and nonenzymatic antioxidant defence, Superoxide dismutase, catalase, Glutathione peroxidase, Glutathione Vitamin C, Vitamin E, α- Lipoic acid, melatonin
Synthetic antioxidants: Butylated hydroxy Toluene, Butylated hydroxy Anisole. Functional foods for chronic disease prevention
Effect of processing, storage and interactions of various environmental factors on the potential of nutraceuticals.
Regulatory Aspects; FSSAI, FDA, FPO, MPO, AGMARK. HACCP and GMPs on Food Safety. Adulteration of foods.
Pharmacopoeial Specifications for dietary supplements and nutraceuticals.
Dietetics by Sri Lakshmi
Role of dietary fibres and neutraceuticals in preventing diseases by K.T Agusti and P.Faizal: BSPunblication.
Advanced Nutritional Therapies by Cooper. K.A., (1996).
The Food Pharmacy by Jean Carper, Simon & Schuster, UK Ltd., (1988). Prescription for Nutritional Healing by James F.Balch and Phyllis A.Balch 2nd
Avery Publishing Group, NY (1997).
Edn.,
6. G. Gibson and C.williams Editors 2000 Functional foods Woodhead Publ.Co.London.
Goldberg, I. Functional Foods. 1994. Chapman and Hall, New York.
Labuza, T.P. 2000 Functional Foods and Dietary Supplements: Safety, Good Manufacturing Practice (GMPs) and Shelf Life Testing in Essentials of Functional Foods M.K. Sachmidl and T.P. Labuza eds. Aspen Press.
Handbook of Nutraceuticals and Functional Foods, Third Edition (Modern Nutrition)
Shils, ME, Olson, JA, Shike, M. 1994 Modern Nutrition in Health and Disease. Eighth edition. Lea and Febiger
Introduction to pharmaceutical product development, objectives, regulations related to preformulation, formulation development, stability assessment, manufacturing and quality control testing of different types of dosage forms
An advanced study of Pharmaceutical Excipients in pharmaceutical product development with a special reference to the following categories
Solvents and solubilizers Cyclodextrins and their applications
Non - ionic surfactants and their applications Polyethylene glycols and sorbitols Suspending and emulsifying agents
Semi solid excipients
An advanced study of Pharmaceutical Excipients in pharmaceutical product development with a special reference to the following categories
Tablet and capsule excipients Directly compressible vehicles Coat materials
Excipients in parenteral and aerosols products Excipients for formulation of NDDS
Selection and application of excipients in pharmaceutical formulations with specific industrial applications
Optimization techniques in pharmaceutical product development.A study of various optimization techniques for pharmaceutical product development with specific examples.Optimization by factorial designs and their applications.A study of QbD and its application in pharmaceutical product development.
Selection and quality control testing of packaging materials for pharmaceutical product development- regulatory considerations.
Pharmaceutical Statistics Practical and Clinical Applications by Stanford Bolton, CharlesBon; Marcel Dekker Inc.
Encyclopedia of Pharmaceutical Technology, edited by James swarbrick, Third Edition,Informa Healthcare publishers.
Pharmaceutical Dosage Forms, Tablets, Volume II, edited by Herbert A. Lieberman andLeon Lachman; Marcel Dekker, Inc.
The Theory and Practice of Industrial Pharmacy, Fourth Edition, edited by Roop kKhar, S P Vyas, Farhan J Ahmad, Gaurav K Jain; CBS Publishers and Distributors Pvt.Ltd. 2013.
Martin’s Physical Pharmacy and Pharmaceutical Sciences, Fifth Edition, edited by Patrick J. Sinko, BI Publications Pvt. Ltd.
Targeted and Controlled Drug Delivery, Novel Carrier Systems by S. P. Vyas and R. K.Khar, CBS Publishers and Distributors Pvt. Ltd, First Edition 2012. Pharmaceutical Dosage Forms and Drug Delivery Systems, Loyd V. Allen Jr., Nicholas B.Popovich, Howard C. Ansel, 9th Ed. 40
Aulton’s Pharmaceutics – The Design and Manufacture of Medicines, Michael E. Aulton,3rd Ed.
Remington – The Science and Practice of Pharmacy, 20th Ed.
Pharmaceutical Dosage Forms – Tablets Vol 1 to 3, A. Liberman, Leon Lachman andJoseph B. Schwartz
Pharmaceutical Dosage Forms – Disperse Systems Vol 1 to 3, H.A. Liberman, Martin, M.R and Gilbert S. Banker.
Pharmaceutical Dosage Forms – Parenteral Medication Vol 1 & 2, Kenneth E. Avis andH.A. Libermann.
Advanced Review Articles related to the topics.
Every candidate shall undergo practice school for a period of 150 hours evenly distributed throughout the semester. The student shall opt any one of the domains for practice school .
At the end of the practice school, every student shall submit a printed report (in triplicate) on the practice school he/she attended (not more than 25 pages). Along with the exams of semester VII, the report submitted by the student, knowledge and skills acquired by the student through practice school shall be evaluated by the subject experts at college level and grade point shall be awarded.
=======Experimental studies, SPSS, R and MINITAB statistical software’s, analyzing the statistical data using Excel.
®
Know the operation of M.S. Excel, SPSS, R and MINITAB , DoE (Design of Experiment)
Know the various statistical techniques to solve statistical problems Appreciate statistical techniques in solving the problems.
- Pharmaceuticals examples
Sample, Population, large sample, small sample, Null hypothesis, alternative hypothesis, sampling, essence of sampling, types of sampling, Error-I type, Error-II type, Standard error of mean (SEM) - Pharmaceutical examples
Blocking and confounding system for Two-level factorials
®
Statistical Analysis Using Excel, SPSS, MINITAB , DESIGN OF EXPERIMENTS, R -
Online Statistical Software’s to Industrial and Clinical trial approach
Factorial Design: Definition, 22, 23design. Advantage of factorial design
Pharmaceutical statistics- Practical and clinical applications, Sanford Bolton, publisher Marcel Dekker Inc. NewYork.
Fundamental of Statistics – Himalaya Publishing House- S.C.Guptha
Design and Analysis of Experiments –PHI Learning Private Limited, R. Pannerselvam,
Design and Analysis of Experiments – Wiley Students Edition,
Douglas and C. Montgomery
The purpose of this course is to introduce to students a number of health issues and their challenges. This course also introduced a number of national health programmes. The roles of the pharmacist in these contexts are also discussed.
After the successful completion of this course, the student shall be able to:
Acquire high consciousness/realization of current issuesrelated to health and pharmaceutical problems within the country and worldwide.
Have a critical way of thinking based on current healthcare development. Evaluate alternative ways of solving problems related tohealth and pharmaceutical issues
programme for prevention and control of deafness, Universal immunization programme, National programme for control of blindness, Pulse polio programme.
National health intervention programme for mother and child, National family welfare programme, National tobacco control programme, National Malaria Prevention Program, National programme for the health care for the elderly, Social health programme; role of WHO in Indian national program
Community services in rural, urban and school health: Functions of PHC, Improvement in rural sanitation, national urban health mission, Health promotion and education in school.
Short Textbook of Preventive and Social Medicine, Prabhakara GN, 2nd Edition, 2010, ISBN: 9789380704104, JAYPEE Publications
Textbook of Preventive and Social Medicine (Mahajan and Gupta), Edited by Roy
th
Rabindra Nath, Saha Indranil, 4 Edition, 2013, ISBN: 9789350901878, JAYPEE Publications
Review of Preventive and Social Medicine (Including Biostatistics), Jain Vivek, 6th
Edition, 2014, ISBN: 9789351522331, JAYPEE Publications
Essentials of Community Medicine—A Practical Approach, Hiremath Lalita D, Hiremath Dhananjaya A, 2nd Edition, 2012, ISBN: 9789350250440, JAYPEE Publications
Park Textbook of Preventive and Social Medicine, K Park, 21st
Edition, 2011,
ISBN-14: 9788190128285, BANARSIDAS BHANOT PUBLISHERS.
Community Pharmacy Practice, Ramesh Adepu, BSP publishers, Hyderabad
1. Research in Social and Administrative Pharmacy, Elsevier, Ireland
The pharmaceutical industry not only needs highly qualified researchers, chemists and, technical people, but also requires skilled managers who can take the industry forward by managing and taking the complex decisions which are imperative for the growth of the industry. The Knowledge and Know-how of marketing management groom the people for taking a challenging role in Sales and Product management.
Definition, general concepts and scope of marketing; Distinction between marketing & selling; Marketing environment; Industry and competitive analysis; Analyzing consumer buying behavior; industrial buying behavior.
Quantitative and qualitative aspects; size and composition of the market; demographic descriptions and socio-psychological characteristics of the consumer; market segmentation& targeting.Consumer profile; Motivation and prescribing habits of the physician; patients' choice of physician and retail pharmacist.Analyzing the Market;Role of market research.
Classification, product line and product mix decisions, product life cycle,product portfolio analysis; product positioning; New product decisions; Product branding, packaging and labeling decisions, Product management in pharmaceutical industry.
Methods, determinants of promotional mix, promotional budget; An overview of personal selling, advertising, direct mail, journals, sampling, retailing, medical exhibition, public relations, online promotional techniques for OTC Products.
Designing channel, channel members, selecting the appropriate channel, conflict in channels, physical distribution management: Strategic importance, tasks in physical distribution management.
Duties of PSR, purpose of detailing, selection and training, supervising, norms for customer calls, motivating, evaluating, compensation and future prospects of the PSR.
Meaning, importance, objectives, determinants of price; pricing methods and strategies, issues in price management in pharmaceutical industry. An overview of DPCO (Drug Price Control Order)and NPPA (National Pharmaceutical Pricing Authority).
Vertical & Horizontal Marketing; RuralMarketing; Consumerism; Industrial Marketing; Global Marketing.
Philip Kotler and Kevin Lane Keller: Marketing Management, Prentice Hall of India, New Delhi
Walker, Boyd and Larreche : Marketing Strategy- Planning and Implementation, Tata MC GrawHill, New Delhi.
Dhruv Grewal and Michael Levy: Marketing, Tata MC Graw Hill
Arun Kumar and N Menakshi: Marketing Management, Vikas Publishing, India Rajan Saxena: Marketing Management; Tata MC Graw-Hill (India Edition) Ramaswamy, U.S & Nanakamari, S: Marketing Managemnt:Global Perspective, IndianContext,Macmilan India, New Delhi.
Shanker, Ravi: Service Marketing, Excell Books, New Delhi
Subba Rao Changanti, Pharmaceutical Marketing in India (GIFT – Excel series) Excel Publications.
know the regulatory approval process and their registration in Indian and international markets
appreciate EU and ICH guidelines for quality control of herbal drugs
Basic tests for drugs – Pharmaceutical substances, Medicinal plants materials and dosage forms
WHO guidelines for quality control of herbal drugs. Evaluation of commercial crude drugs intended for use
WHO Guidelines on current good manufacturing Practices (cGMP) for Herbal Medicines WHO Guidelines on GACP for Medicinal Plants.
EU and ICH guidelines for quality control of herbal drugs.
Research Guidelines for Evaluating the Safety and Efficacy of Herbal Medicines
Stability testing of herbal medicines.Application of various chromatographic techniques in standardization of herbal products.
Preparation of documents for new drug application and export registration GMP requirements and Drugs & Cosmetics Act provisions.
Regulatory requirements for herbal medicines.
WHO guidelines on safety monitoring of herbal medicines in pharmacovigilance systems Comparison of various Herbal Pharmacopoeias.
Role of chemical and biological markers in standardization of herbal products
Rangari, V.D., Text book of Pharmacognosy and Phytochemistry Vol. I , Carrier Pub., 2006.
Aggrawal, S.S., Herbal Drug Technology. Universities Press, 2002. EMEA. Guidelines on Quality of Herbal Medicinal Products/Traditional Medicinal Products,
Mukherjee, P.W. Quality Control of Herbal Drugs: An Approach to Evaluation of Botanicals. Business Horizons Publishers, New Delhi, India, 2002.
Shinde M.V., Dhalwal K., Potdar K., Mahadik K. Application of quality control principles to herbal drugs. International Journal of Phytomedicine 1(2009); p. 4-8. WHO. Quality Control Methods for Medicinal Plant Materials, World Health Organization, Geneva, 1998. WHO. Guidelines for the Appropriate Use of Herbal Medicines. WHO Regional Publications, Western Pacific Series No 3, WHO Regional office for the Western Pacific, Manila, 1998.
WHO. The International Pharmacopeia, Vol. 2: Quality Specifications, 3rd edn. World Health Organization, Geneva, 1981.
WHO. Quality Control Methods for Medicinal Plant Materials. World Health Organization, Geneva, 1999.
WHO. WHO Global Atlas of Traditional, Complementary and Alternative Medicine. 2 vol. set. Vol. 1 contains text and Vol. 2, maps. World Health Organization, Geneva, 2005.
WHO. Guidelines on Good Agricultural and Collection Practices (GACP) for Medicinal Plants. World Health Organization, Geneva, 2004.
Classification of cosmetic and cosmeceutical products
Definition of cosmetics as per Indian and EU regulations, Evolution of cosmeceuticals from cosmetics, cosmetics as quasi and OTC drugs
Face wash,
Moisturizing cream, Cold Cream, Vanishing cream and their advantages and disadvantages.Application of these products in formulation of cosmecuticals. Antiperspants & deodorants- Actives & mechanism of action.
Conditioning shampoo, Hair conditioner,anti-dandruff shampoo. Hair oils.
Chemistry and formulation of Para-phylene diamine based hair dye. Principles of formulation and building blocks of oral care products: Toothpaste for bleeding gums, sensitive teeth. Teeth whitening, Mouthwash.
Sun protection, Classification of Sunscreens and SPF.
Skin Care: Aloe and turmeric Hair care: Henna and amla.
Oral care: Neem and clove
Principles of Cosmetic Evaluation:Principles of sebumeter, corneometer. Measurement of TEWL, Skin Color, Hair tensile strength, Hair combing properties
Soaps,and syndet bars. Evolution and skin benfits.
Oily and dry skin, causes leading to dry skin, skin moisturisation. Basic understanding of the terms Comedogenic, dermatitis.
Cosmetic problems associated with Hair and scalp: Dandruff, Hair fall causes Cosmetic problems associated with skin: blemishes, wrinkles, acne, prickly heat and body odor.
Antiperspirants and Deodorants- Actives and mechanism of action
Harry’s Cosmeticology, Wilkinson, Moore, Seventh Edition, George Godwin. Cosmetics – Formulations, Manufacturing and Quality Control, P.P. Sharma, 4th Edition, Vandana Publications Pvt. Ltd., Delhi.
Text book of cosmelicology by Sanju Nanda & Roop K. Khar, Tata Publishers.
Upon completion of the course the student shall be able to,
Appreciate the applications of various commonly used laboratory animals.
Appreciate and demonstrate the various screening methods used in preclinical research
Appreciate and demonstrate the importance of biostatistics and researchmethodology Design and execute a research hypothesis independently
Study of CPCSEA and OECD guidelines for maintenance, breeding and conduct of experiments on laboratory animals, Common lab animals: Description and applications of different species and strains of animals. Popular transgenic and mutant animals.
Techniques for collection of blood and common routes of drug administration in laboratory animals, Techniques of blood collection and euthanasia.
a. Introduction: Dose selection, calculation and conversions, preparation of drug solution/suspensions, grouping of animals and importance of sham negative and positive control groups. Rationale for selection of animal species and sex for the study.
Diuretics, nootropics, anti-Parkinson’s,antiasthmatics, Preclinical screening models: for CNS activity- analgesic, antipyretic,anti-inflammatory, general anaesthetics, sedative and hypnotics, antipsychotic, antidepressant, antiepileptic, antiparkinsonism, alzheimer’s disease
Preclinical screening models for other important drugs like antiulcer, antidiabetic, anticancer and antiasthmatics.
Selection of research topic, review of literature, research hypothesis and study design
Pre-clinical data analysis and interpretation using Students ‘t’ test and One-way ANOVA. Graphical representation of data
Fundamentals of experimental Pharmacology-by M.N.Ghosh Hand book of Experimental Pharmacology-S.K.Kulakarni CPCSEA guidelines for laboratory animal facility.
Drug discovery and Evaluation by Vogel H.G.
Drug Screening Methods by Suresh Kumar Gupta and S. K. Gupta Introduction to biostatistics and research methods by PSS Sundar Rao and J Richard
understand the advanced instruments used and its applications in drug analysis understand the chromatographic separation and analysis of drugs.
understand the calibration of various analytical instruments know analysis of drugs using various analytical instruments.
Principles of H-NMR and C-NMR, chemical shift, factors affecting chemical shift, coupling constant, Spin - spin coupling, relaxation, instrumentation and applications
Crystallography, rotating crystal technique, single crystal diffraction,powder diffraction, structural elucidation and applications.
Electronic balance, UV-Visible spectrophotometer, IR spectrophotometer,
Fluorimeter, Flame Photometer, HPLC and GC
Instrumental Methods of Chemical Analysis by B.K Sharma Organic spectroscopy by Y.R Sharma
3. Text book of Pharmaceutical Analysis by Kenneth A. Connors Vogel’s Text book of Quantitative Chemical Analysis by A.I. Vogel Practical Pharmaceutical Chemistry by A.H. Beckett and J.B. Stenlake Organic Chemistry by I. L. Finar
Organic spectroscopy by William Kemp Quantitative Analysis of Drugs by D. C. Garrett
Quantitative Analysis of Drugs in Pharmaceutical Formulations by P. D. Sethi Spectrophotometric identification of Organic Compounds by Silver
Know the regulatory authorities and agencies governing the manufacture and sale of pharmaceuticals
Know the regulatory approval process and their registration in Indian and international markets
Stages of drug discovery, Drug development process, pre-clinical studies, non-clinical activities, clinical studies, Innovator and generics, Concept of generics, Generic drug product development.
Approval processes and timelines involved in Investigational New Drug (IND), New Drug Application (NDA), Abbreviated New Drug Application (ANDA). Changes to an approved NDA / ANDA.
Overview of regulatory authorities of India, United States, European Union, Australia, Japan, Canada (Organization structure and types of applications)
Procedure for export of pharmaceutical products, Technical documentation, Drug Master Files (DMF), Common Technical Document (CTD), electronic Common Technical
Document (eCTD), ASEAN Common Technical Document (ACTD)research.
Developing clinical trial protocols, Institutional Review Board / Independent Ethics committee - formation and working procedures, Informed consent process and procedures, GCP obligations of Investigators, sponsors & Monitors, Managing and Monitoring clinical trials, Pharmacovigilance - safety monitoring in clinical trials
Basic terminology, guidance, guidelines, regulations, Laws and Acts, Orange book, Federal Register, Code of Federal Regulatory, Purple book
Drug Regulatory Affairs by Sachin Itkar, Dr. N.S. Vyawahare, Nirali Prakashan. The Pharmaceutical Regulatory Process, Second Edition Edited by Ira R. Berry and Robert P. Martin, Drugs and the Pharmaceutical Sciences,Vol.185. Informa Health care Publishers.
New Drug Approval Process: Accelerating Global Registrations By Richard
th
A Guarino, MD, 5 edition, Drugs and the Pharmaceutical Sciences,Vol.190.
Guidebook for drug regulatory submissions / Sandy Weinberg. By John Wiley & Sons. Inc.
FDA Regulatory Affairs: a guide for prescription drugs, medical devices, and biologics /edited by Douglas J. Pisano, David Mantus.
Generic Drug Product Development, Solid Oral Dosage forms, Leon Shargel and Isader Kaufer, Marcel Dekker series, Vol.143
Clinical Trials and Human Research: A Practical Guide to Regulatory Compliance By Fay A. Rozovsky and Rodney K. Adams
Principles and Practices of Clinical Research, Second Edition Edited by John I. Gallin and Frederick P. Ognibene
Drugs: From Discovery to Approval, Second Edition By Rick
Scope: This paper will provide an opportunity for the student to learn about development of pharmacovigilance as a science, basic terminologies used in pharmacovigilance, global scenario of Pharmacovigilance, train students on establishing pharmacovigilance programme in an organization, various methods that can be used to generate safety data and signal detection. This paper also develops the skills of classifying drugs, diseases and adverse drug reactions.
Objectives:
At completion of this paper it is expected that students will be able to (know, do, and appreciate):
Why drug safety monitoring is important? History and development of pharmacovigilance
National and international scenario of pharmacovigilance Dictionaries, coding and terminologies used in pharmacovigilance Detection of new adverse drug reactions and their assessment International standards for classification of diseases and drugs
Adverse drug reaction reporting systems and communication in pharmacovigilance Methods to generate safety data during pre clinical, clinical and post approval phases of drugs’ life cycle
Drug safety evaluation in paediatrics, geriatrics, pregnancy and lactation Pharmacovigilance Program of India (PvPI) requirement for ADR reporting in India ICH guidelines for ICSR, PSUR, expedited reporting, pharmacovigilance planning CIOMS requirements for ADR reporting
Writing case narratives of adverse events and their quality.
Unit I
Introduction to Pharmacovigilance
History and development of Pharmacovigilance Importance of safety monitoring of Medicine WHO international drug monitoring programme Pharmacovigilance Program of India(PvPI)
Introduction to adverse drug reactions Definitions and classification of ADRs Detection and reporting
Methods in Causality assessment Severity and seriousness assessment
Predictability and preventability assessment Management of adverse drug reactions
Basic terminologies used in pharmacovigilance
Terminologies of adverse medication related events Regulatory terminologies
Unit II
Drug and disease classification
Anatomical, therapeutic and chemical classification of drugs International classification of diseases
Daily defined doses
International Non proprietary Names for drugs
Drug dictionaries and coding in pharmacovigilance WHO adverse reaction terminologies MedDRA and Standardised MedDRA queries WHO drug dictionary
Eudravigilance medicinal product dictionary
Information resources in pharmacovigilance Basic drug information resources Specialised resources for ADRs
Establishing pharmacovigilance programme
Establishing in a hospital
Establishment & operation of drug safety department in industry Contract Research Organisations (CROs)
Establishing a national programme
Unit III
Vaccine safety surveillance
Vaccine Pharmacovigilance Vaccination failure
Adverse events following immunization
Pharmacovigilance methods
Passive surveillance – Spontaneous reports and case series Stimulated reporting
Active surveillance – Sentinel sites, drug event monitoring and registries Comparative observational studies – Cross sectional study, case control study and cohort study
Targeted clinical investigations
Communication in pharmacovigilance
Effective communication in Pharmacovigilance Communication in Drug Safety Crisis management
Communicating with Regulatory Agencies, Business Partners, Healthcare facilities & Media
Unit IV
Safety data generation
1 Pre clinical phase
1 Clinical phase
1 Post approval phase (PMS)
ICH Guidelines for Pharmacovigilance
1 Organization and objectives of ICH
1 Expedited reporting
1 Individual case safety reports
1 Periodic safety update reports
1 Post approval expedited reporting
1 Pharmacovigilance planning
1 Good clinical practice in pharmacovigilance studie
Unit V
Pharmacogenomics of adverse drug reactions
Genetics related ADR with example focusing PK parameters.
Drug safety evaluation in special population
Paediatrics
Pregnancy and lactation Geriatrics
CIOMS
CIOMS Working Groups CIOMS Form
CDSCO (India) and Pharmacovigilance
D&C Act and Schedule Y
Differences in Indian and global pharmacovigilance requirements
Textbook of Pharmacovigilance: S K Gupta, Jaypee Brothers, Medical Publishers. Practical Drug Safety from A to Z By Barton Cobert, Pierre Biron, Jones and Bartlett Publishers.
Mann's Pharmacovigilance:Elizabeth B. Andrews, Nicholas, Wiley Publishers. Stephens' Detection of New Adverse Drug Reactions: John Talbot, Patrick Walle, Wiley Publishers.
An Introduction to Pharmacovigilance: Patrick Waller,Wiley Publishers. Cobert's Manual of Drug Safety and Pharmacovigilance: Barton Cobert,Jones& Bartlett Publishers.
Textbook of Pharmacoepidemiolog edited by Brian L. Strom, Stephen E Kimmel, Sean Hennessy,Wiley Publishers.
A Textbook of Clinical Pharmacy Practice -Essential Concepts and Skills:G. Parthasarathi, Karin NyfortHansen,Milap C. Nahata
National Formulary of India
Text Book of Medicine by Yashpal Munjal
Text book of Pharmacovigilance: concept and practice by GP Mohanta and PK Manna
Design and discovery of lead molecules
The role of drug design in drug discovery process The concept of QSAR and docking
Various strategies to develop new drug like molecules.
The design of new drug molecules using molecular modeling software
Stages of drug discovery and development
Rational approaches to lead discovery based on traditional medicine, Random screening, Non-random screening, serendipitous drug discovery, lead discovery based on drug metabolism, lead discovery based on clinical observation.
SAR versus QSAR, History and development of QSAR, Types of physicochemical parameters, experimental and theoretical approaches for the determination of physicochemical parameters such as Partition coefficient, Hammet’s substituent constant and Tafts steric constant. Hansch analysis, Free Wilson analysis, 3D-QSAR approaches like COMFA and COMSIA.
Molecular docking: Rigid docking, flexible docking, manual docking, Docking based screening. De novo drug design.
Introduction to Bioinformatics, chemoinformatics. ADME databases, chemical, biochemical and pharmaceutical databases.
Robert GCK, ed., “Drug Action at the Molecular Level” University Prak Press Baltimore.
Martin YC. “Quantitative Drug Design” Dekker, New York.
Delgado JN, Remers WA eds “Wilson & Gisvolds’s Text Book of Organic Medicinal & Pharmaceutical Chemistry” Lippincott, New York.
Foye WO “Principles of Medicinal chemistry ‘Lea & Febiger.
Koro lkovas A, Burckhalter JH. “Essentials of Medicinal Chemistry” Wiley Interscience.
Wolf ME, ed “The Basis of Medicinal Chemistry, Burger’s Medicinal Chemistry” John Wiley & Sons, New York.
Patrick Graham, L., An Introduction to Medicinal Chemistry, Oxford University Press.
Smith HJ, Williams H, eds, “Introduction to the principles of Drug Design” Wright Boston.
Silverman R.B. “The organic Chemistry of Drug Design and Drug Action” Academic Press New York.
Cell biology is a branch of biology that studies cells – their physiological properties, their structure, the organelles they contain, interactions with their environment, their life cycle, division, death and cell function.
This is done both on a microscopic and molecular level.
Cell biology research encompasses both the great diversity of single-celled organisms like bacteria and protozoa, as well as the many specialized cells in multi-cellular organismssuch as humans, plants, and sponges.
Summarize cellular functioning and composition. Describe the chemical foundations of cell biology. Summarize the DNA properties of cell biology.
Describe protein structure and function.
Describe cellular membrane structure and function. Describe basic molecular genetic mechanisms.
Summarize the Cell Cycle
Cell and Molecular Biology: Definitions theory and basics and Applications. Cell and Molecular Biology: History and Summation.
Properties of cells and cell membrane. Prokaryotic versus Eukaryotic Cellular Reproduction
Chemical Foundations – an Introduction and Reactions (Types)
DNA and the Flow of Molecular Information DNA Functioning
DNA and RNA Types of RNA
Transcription and Translation
Proteins: Defined and Amino Acids Protein Structure
Regularities in Protein Pathways Cellular Processes
Positive Control and significance of Protein Synthesis
Science of Genetics
Transgenics and Genomic Analysis Cell Cycle analysis
Mitosis and Meiosis
Cellular Activities and Checkpoints
Cell Signals: Introduction Receptors for Cell Signals Signaling Pathways: Overview
Misregulation of Signaling Pathways Protein-Kinases: Functioning
W.B. Hugo and A.D. Russel: Pharmaceutical Microbiology, Blackwell Scientific publications, Oxford London.
Prescott and Dunn., Industrial Microbiology, 4th edition, CBS Publishers
& Distributors, Delhi.
Pelczar, Chan Kreig, Microbiology, Tata McGraw Hill edn.
Malcolm Harris, Balliere Tindall and Cox: Pharmaceutical Microbiology. Rose: Industrial Microbiology.
Probisher, Hinsdill et al: Fundamentals of Microbiology, 9th ed. Japan Cooper and Gunn’s: Tutorial Pharmacy, CBS Publisher and Distribution. Peppler: Microbial Technology.
Edward: Fundamentals of Microbiology.
N.K.Jain: Pharmaceutical Microbiology, Vallabh Prakashan, Delhi
Bergeys manual of systematic bacteriology, Williams and Wilkins- A Waverly company
B.R. Glick and J.J. Pasternak: Molecular Biotechnology: Principles and Applications of RecombinantDNA: ASM Press Washington D.C.
RA Goldshy et. al., : Kuby Immunology.
This subject covers foundational topic that are important for understanding the need and requirements of dietary supplements among different groups in the population.
This module aims to provide an understanding of the concepts behind the theoretical applications of dietary supplements. By the end of the course, students should be able to :
Understand the need of supplements by the different group of people to maintain healthy life.
Understand the outcome of deficiencies in dietary supplements. Appreciate the components in dietary supplements and the application.
Appreciate the regulatory and commercial aspects of dietary supplements including health claims.
Definitions of Functional foods, Nutraceuticals and Dietary supplements. Classification of Nutraceuticals, Health problems and diseases that can be prevented or cured by Nutraceuticals i.e. weight control, diabetes, cancer, heart disease, stress, osteoarthritis, hypertension etc.
Public health nutrition, maternal and child nutrition, nutrition and ageing, nutrition education in community.
Source, Name of marker compounds and their chemical nature, Medicinal uses and
health benefits of following used as nutraceuticals/functional foods: Spirulina, Soyabean, Ginseng, Garlic, Broccoli, Gingko, Flaxseeds
Phytochemicals as nutraceuticals: Occurrence and characteristic features(chemical nature medicinal benefits) of following
Carotenoids- α and β-Carotene, Lycopene, Xanthophylls, leutin Sulfides: Diallyl sulfides, Allyl trisulfide.
Polyphenolics: Reservetrol
Flavonoids- Rutin , Naringin, Quercitin, Anthocyanidins, catechins, Flavones Prebiotics / Probiotics.: Fructo oligosaccharides, Lacto bacillum
Phyto estrogens : Isoflavones, daidzein, Geebustin, lignans Tocopherols
Proteins, vitamins, minerals, cereal, vegetables and beverages as functional foods: oats, wheat bran, rice bran, sea foods, coffee, tea and the like.
Introduction to free radicals: Free radicals, reactive oxygen species, production of free radicals in cells, damaging reactions of free radicals on lipids, proteins, Carbohydrates, nucleic acids.
b) Dietary fibres and complex carbohydrates as functional food ingredients..
Free radicals in Diabetes mellitus, Inflammation, Ischemic reperfusion injury, Cancer, Atherosclerosis, Free radicals in brain metabolism and pathology, kidney damage, muscle damage. Free radicals involvement in other disorders. Free radicals theory of ageing.
Antioxidants: Endogenous antioxidants – enzymatic and nonenzymatic antioxidant defence, Superoxide dismutase, catalase, Glutathione peroxidase, Glutathione Vitamin C, Vitamin E, α- Lipoic acid, melatonin
Synthetic antioxidants: Butylated hydroxy Toluene, Butylated hydroxy Anisole. Functional foods for chronic disease prevention
Effect of processing, storage and interactions of various environmental factors on the potential of nutraceuticals.
Regulatory Aspects; FSSAI, FDA, FPO, MPO, AGMARK. HACCP and GMPs on Food Safety. Adulteration of foods.
Pharmacopoeial Specifications for dietary supplements and nutraceuticals.
Dietetics by Sri Lakshmi
Role of dietary fibres and neutraceuticals in preventing diseases by K.T Agusti and P.Faizal: BSPunblication.
Advanced Nutritional Therapies by Cooper. K.A., (1996).
The Food Pharmacy by Jean Carper, Simon & Schuster, UK Ltd., (1988). Prescription for Nutritional Healing by James F.Balch and Phyllis A.Balch 2nd
Avery Publishing Group, NY (1997).
Edn.,
6. G. Gibson and C.williams Editors 2000 Functional foods Woodhead Publ.Co.London.
Goldberg, I. Functional Foods. 1994. Chapman and Hall, New York.
Labuza, T.P. 2000 Functional Foods and Dietary Supplements: Safety, Good Manufacturing Practice (GMPs) and Shelf Life Testing in Essentials of Functional Foods M.K. Sachmidl and T.P. Labuza eds. Aspen Press.
Handbook of Nutraceuticals and Functional Foods, Third Edition (Modern Nutrition)
Shils, ME, Olson, JA, Shike, M. 1994 Modern Nutrition in Health and Disease. Eighth edition. Lea and Febiger
Introduction to pharmaceutical product development, objectives, regulations related to preformulation, formulation development, stability assessment, manufacturing and quality control testing of different types of dosage forms
An advanced study of Pharmaceutical Excipients in pharmaceutical product development with a special reference to the following categories
Solvents and solubilizers Cyclodextrins and their applications
Non - ionic surfactants and their applications Polyethylene glycols and sorbitols Suspending and emulsifying agents
Semi solid excipients
An advanced study of Pharmaceutical Excipients in pharmaceutical product development with a special reference to the following categories
Tablet and capsule excipients Directly compressible vehicles Coat materials
Excipients in parenteral and aerosols products Excipients for formulation of NDDS
Selection and application of excipients in pharmaceutical formulations with specific industrial applications
Optimization techniques in pharmaceutical product development.A study of various optimization techniques for pharmaceutical product development with specific examples.Optimization by factorial designs and their applications.A study of QbD and its application in pharmaceutical product development.
Selection and quality control testing of packaging materials for pharmaceutical product development- regulatory considerations.
Pharmaceutical Statistics Practical and Clinical Applications by Stanford Bolton, CharlesBon; Marcel Dekker Inc.
Encyclopedia of Pharmaceutical Technology, edited by James swarbrick, Third Edition,Informa Healthcare publishers.
Pharmaceutical Dosage Forms, Tablets, Volume II, edited by Herbert A. Lieberman andLeon Lachman; Marcel Dekker, Inc.
The Theory and Practice of Industrial Pharmacy, Fourth Edition, edited by Roop kKhar, S P Vyas, Farhan J Ahmad, Gaurav K Jain; CBS Publishers and Distributors Pvt.Ltd. 2013.
Martin’s Physical Pharmacy and Pharmaceutical Sciences, Fifth Edition, edited by Patrick J. Sinko, BI Publications Pvt. Ltd.
Targeted and Controlled Drug Delivery, Novel Carrier Systems by S. P. Vyas and R. K.Khar, CBS Publishers and Distributors Pvt. Ltd, First Edition 2012. Pharmaceutical Dosage Forms and Drug Delivery Systems, Loyd V. Allen Jr., Nicholas B.Popovich, Howard C. Ansel, 9th Ed. 40
Aulton’s Pharmaceutics – The Design and Manufacture of Medicines, Michael E. Aulton,3rd Ed.
Remington – The Science and Practice of Pharmacy, 20th Ed.
Pharmaceutical Dosage Forms – Tablets Vol 1 to 3, A. Liberman, Leon Lachman andJoseph B. Schwartz
Pharmaceutical Dosage Forms – Disperse Systems Vol 1 to 3, H.A. Liberman, Martin, M.R and Gilbert S. Banker.
Pharmaceutical Dosage Forms – Parenteral Medication Vol 1 & 2, Kenneth E. Avis andH.A. Libermann.
Advanced Review Articles related to the topics.
Every candidate shall undergo practice school for a period of 150 hours evenly distributed throughout the semester. The student shall opt any one of the domains for practice school .
At the end of the practice school, every student shall submit a printed report (in triplicate) on the practice school he/she attended (not more than 25 pages). Along with the exams of semester VII, the report submitted by the student, knowledge and skills acquired by the student through practice school shall be evaluated by the subject experts at college level and grade point shall be awarded.
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