B.PHARM.

SEMESTER- VIII

Radha raman college of pharmacy bhopal mp

 B.PHARM. SEMESTER- VIII
BP 801T BIOSTATISITCS AND RESEARCH METHODOLOGY (Theory)

Scope: To understand the applications of Biostatics in Pharmacy. This subject deals with
descriptive statistics, Graphics, Correlation, Regression, logistic regression Probability
theory, Sampling technique, Parametric tests, Non Parametric tests, ANOVA, Introduction
to Design of Experiments, Phases of Clinical trials and Observational and
Experimental studies, SPSS, R and MINITAB statistical software’s, analyzing the
statistical data using Excel.

Objectives: Upon completion of the course the student shall be able to

®
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.

Course content:
Unit-I
Introduction: Statistics, Biostatistics, Frequency distribution
Measures of central tendency: Mean, Median, Mode- Pharmaceutical examples
Measures of dispersion: Dispersion, Range, standard deviation, Pharmaceutical
problems
Correlation: Definition, Karl Pearson’s coefficient of correlation, Multiple correlation
- Pharmaceuticals examples

Unit-II
Regression: Curve fitting by the method of least squares, fitting the lines y= a + bx and
x = a + by, Multiple regression, standard error of regression– Pharmaceutical Examples
Probability:Definition of probability, Binomial distribution, Normal distribution,
Poisson’s distribution, properties - problems
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
Parametric test: t-test(Sample, Pooled or Unpaired and Paired) , ANOVA, (One way
and Two way), Least Significance difference

Unit-III
Non Parametric tests: Wilcoxon Rank Sum Test, Mann-Whitney U test, Kruskal-
Wallis test, Friedman Test
Introduction to Research: Need for research, Need for design of
Experiments, Experiential Design Technique, plagiarism
Graphs: Histogram, Pie Chart, Cubic Graph, response surface plot, Counter Plot graph
Designing the methodology: Sample size determination and Power of a study, Report
writing and presentation of data, Protocol, Cohorts studies, Observational studies,
Experimental studies, Designing clinical trial, various phases.

Unit-IV
Blocking and confounding system for Two-level factorials
Regression modeling: Hypothesis testing in Simple and Multiple regressionmodels
Introduction to Practical components of Industrial and Clinical Trials Problems:
®
Statistical Analysis Using Excel, SPSS, MINITAB , DESIGN OF EXPERIMENTS, R -
Online Statistical Software’s to Industrial and Clinical trial approach

Unit-V
Design and Analysis of experiments:
2 3
Factorial Design: Definition, 2 , 2 design. Advantage of factorial design
Response Surface methodology: Central composite design, Historical
design, Optimization Techniques

Recommended Books (Latest edition):

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
 BP- 802T SOCIAL AND PREVENTIVE PHARMACY(Theory)

Scope:
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.

Objectives:
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
Course content:

Unit I:
Concept of health and disease: Definition, concepts and evaluation of public health.
Understanding the concept of prevention and control of disease, social causes of diseases
and social problems of the sick.

Social and health education: Food in relation to nutrition and health, Balanced diet,
Nutritional deficiencies, Vitamin deficiencies, Malnutrition and its prevention.

Sociology and health: Socio cultural factors related to health and disease, Impact of
urbanization on health and disease, Poverty and health

Hygiene and health: personal hygiene and health care; avoidable habits

Unit II:
Preventive medicine: General principles of prevention and control of diseases such as
cholera, SARS, Ebola virus, influenza, acute respiratory infections, malaria, chicken
guinea, dengue, lymphatic filariasis, pneumonia, hypertension, diabetes mellitus, cancer,
drug addiction-drug substance abuse

Unit III:
National health programs, its objectives, functioning and outcome of the following:
HIV AND AIDS control programme, TB, Integrated disease surveillance program
(IDSP), National leprosy control programme, National mental health program, National
programme for prevention and control of deafness, Universal immunization programme,
National programme for control of blindness, Pulse polio programme.

Unit IV:
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

Unit V:
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.

Recommended Books (Latest edition):

nd
Short Textbook of Preventive and Social Medicine, Prabhakara GN, 2 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
th
Review of Preventive and Social Medicine (Including Biostatistics), Jain Vivek, 6
Edition, 2014, ISBN: 9789351522331, JAYPEE Publications
Essentials of Community Medicine—A Practical Approach, Hiremath Lalita D,
nd
Hiremath Dhananjaya A, 2 Edition, 2012, ISBN: 9789350250440, JAYPEE
Publications
st
Park Textbook of Preventive and Social Medicine, K Park, 21 Edition, 2011,
ISBN-14: 9788190128285, BANARSIDAS BHANOT PUBLISHERS.
Community Pharmacy Practice, Ramesh Adepu, BSP publishers, Hyderabad

Recommended Journals:

1. Research in Social and Administrative Pharmacy, Elsevier, Ireland

 BP-803T (A) PHARMACEUTICAL MARKETING MANAGEMENT (Theory)

Scope:
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.

Course Objective: The course aims to provide an understanding of marketing concepts

and techniques and their applications in the pharmaceutical industry.

Unit I
Marketing:

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

Pharmaceutical market:
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.

Unit II
Product decision:
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.

Unit III
Promotion:
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.
Unit IV
Pharmaceutical marketing channels:
Designing channel, channel members, selecting the appropriate channel, conflict in
channels, physical distribution management: Strategic importance, tasks in physical
distribution management.

Professional sales representative (PSR):

Duties of PSR, purpose of detailing, selection and training, supervising, norms for
customer calls, motivating, evaluating, compensation and future prospects of the PSR.

Unit V
Pricing:
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).

Emerging concepts in marketing:

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

Recommended Books: (Latest Editions)

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.
BP-803T(B) QUALITY CONTROL AND STANDARDIZATION OF HERBALS
(Theory)

Scope: In this subject the student learns about the various methods and guidelines for
evaluation and standardization of herbs and herbal drugs. The subject also provides an
opportunity for the student to learn cGMP, GAP and GLP in traditional system of
medicines.

Objectives: Upon completion of the subject student shall be able to;

know WHO guidelines for quality control of herbal drugs
know Quality assurance in herbal drug industry
know the regulatory approval process and their registration in Indian
and international markets
appreciate EU and ICH guidelines for quality control of herbal drugs

Unit I
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

Unit II
Quality assurance in herbal drug industry of cGMP, GAP, GMP and GLP in
traditional system of medicine.

WHO Guidelines on current good manufacturing Practices (cGMP) for Herbal

Medicines WHO Guidelines on GACP for Medicinal Plants.

Unit III
EU and ICH guidelines for quality control of herbal drugs.
Research Guidelines for Evaluating the Safety and Efficacy of Herbal Medicines

Unit IV
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.
Unit V
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

Recommended Books: (Latest Editions

Pharmacognosy by Trease and Evans
Pharmacognosy by Kokate, Purohit and Gokhale
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.
 BP-803T(C) COSMETIC SCIENCE (Theory)

UNIT I
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
Cosmetic excipients: Surfactants, rheology modifiers, humectants,
emollients, preservatives. Classification and application Skin: Basic structure
and function of skin.
Hair: Basic structure of hair. Hair growth cycle.
Oral Cavity: Common problem associated with teeth and gums.

UNIT II
Principles of formulation and building blocks of skin care products:
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.
Principles of formulation and building blocks of Hair care products:
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.

UNIT III
Sun protection, Classification of Sunscreens and SPF.
Role of herbs in cosmetics:
Skin Care: Aloe and turmeric
Hair care: Henna and amla.
Oral care: Neem and clove
Analytical cosmetics: BIS specification and analytical methods for shampoo, skin-
cream and toothpaste.

UNIT IV
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.
UNIT V
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

References
Harry’s Cosmeticology, Wilkinson, Moore, Seventh Edition, George Godwin.
th
Cosmetics – Formulations, Manufacturing and Quality Control, P.P. Sharma, 4
Edition, Vandana Publications Pvt. Ltd., Delhi.
Text book of cosmelicology by Sanju Nanda & Roop K. Khar, Tata Publishers.
 BP-803T(D) PHARMACOLOGICAL SCREENING METHODS

Scope:This subject is designed to impart the basic knowledge of preclinical studies in

experimental animals including design, conduct and interpretations of results.

Objectives
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

Unit –I
Laboratory Animals:
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.
Unit –II

Preclinical screening models

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.
Study of screening animal models for
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
Unit –III

Preclinical screening models: for ANS activity, sympathomimetics,

sympatholytics, parasympathomimetics, parasympatholytics, skeletal
muscle relaxants, drugs acting on eye, local anaethetics

Unit –IV

Preclinical screening models: for CVS activity- antihypertensives,

diuretics, antiarrhythmic, antidyslepidemic, anti aggregatory,
coagulants, and anticoagulants
Preclinical screening models for other important drugs like antiulcer,
antidiabetic, anticancer and antiasthmatics.

Research methodology and Bio-statistics

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
Recommended Books (latest edition):

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
 BP- 803T (E) ADVANCED INSTRUMENTATION TECHNIQUES (Theory)

Scope: This subject deals with the application of instrumental methods in qualitative and
quantitative analysis of drugs. This subject is designed to impart advanced knowledge on
the principles and instrumentation of spectroscopic and chromatographic hyphenated
techniques. This also emphasizes on theoretical and practical knowledge on modern
analytical instruments that are used for drug testing.

Objectives:Upon completion of the course the student shall be able to

 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.

Course Content:
UNIT-I
Nuclear Magnetic Resonance spectroscopy
Principles of H-NMR and C-NMR, chemical shift, factors affecting chemical
shift, coupling constant, Spin - spin coupling, relaxation, instrumentation and
applications
Mass Spectrometry- Principles, Fragmentation, Ionization techniques –
Electron impact, chemical ionization, MALDI, FAB, Analyzers-Time of
flight and Quadrupole, instrumentation, applications

UNIT-II
Thermal Methods of Analysis: Principles, instrumentation and applications of
ThermogravimetricAnalysis (TGA), Differential Thermal Analysis (DTA),
Differential Scanning Calorimetry (DSC)
X-Ray Diffraction Methods: Origin of X-rays, basic aspects of crystals, X
ray
Crystallography, rotating crystal technique, single crystal diffraction,powder
diffraction, structural elucidation and applications.

UNIT-III
Calibration and validation-as per ICH and USFDA
guidelines Calibration of following Instruments
Electronic balance, UV-Visible spectrophotometer, IR spectrophotometer,
Fluorimeter, Flame Photometer, HPLC and GC

UNIT-IV
Radio immune assay:Importance, various components, Principle, different
methods, Limitation and Applications of Radio immuno assay
Extraction techniques:General principle and procedure involved in the solid
phase extraction and liquid-liquid extraction

UNIT-V
Hyphenated techniques-LC-MS/MS, GC-MS/MS, HPTLC-MS.

Recommended Books (Latest Editions)

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
 BP-804T (A): PHARMACEUTICAL REGULATORY SCIENCE (Theory)

Scope: This course is designed to impart the fundamental knowledge on the regulatory
requirements for approval of new drugs, and drug products in regulated markets of India &
other countries like US, EU, Japan, Australia,UK etc. It prepares the students to learn in
detail on the regulatory requirements, documentation requirements, and registration
procedures for marketing the drug products.

Objectives: Upon completion of the subject student shall be able to;

Know about the process of drug discovery and development
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
Course content:

Unit I

New Drug Discovery and development

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.

Unit II

Regulatory Approval Process

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.
Regulatory authorities and agencies
Overview of regulatory authorities of India, United States, European Union, Australia,
Japan, Canada (Organization structure and types of applications)

Unit III

Registration of Indian drug product in overseas market

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.

Unit IV

Clinical trials
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

Unit V

Regulatory Concepts
Basic terminology, guidance, guidelines, regulations, Laws and Acts, Orange book,
Federal Register, Code of Federal Regulatory, Purple book

Recommended books (Latest edition):

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
 BP- 804T(B): PHARMACOVIGILANCE (Theory)

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.

Course Content

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

Pre clinical phase
Clinical phase
Post approval phase (PMS)
ICH Guidelines for Pharmacovigilance
Organization and objectives of ICH
Expedited reporting
Individual case safety reports
Periodic safety update reports
Post approval expedited reporting
Pharmacovigilance planning
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

Recommended Books (Latest edition):

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
 BP- 804T(C) COMPUTER AIDED DRUG DESIGN (Theory)

Scope: This subject is designed to provide detailed knowledge of rational drug design
process and various techniques used in rational drug design process.
Objectives: Upon completion of the course, the student shall be able to understand
 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

Course Content:
UNIT-I
Introduction to Drug Discovery and Development
Stages of drug discovery and development
Lead discovery and Analog Based Drug Design
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.
Analog Based Drug Design:Bioisosterism, Classification, Bioisosteric
replacement. Any three case studies

UNIT-II
Quantitative Structure Activity Relationship (QSAR)
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.

UNIT-III
Molecular Modeling and virtual screening techniques
Virtual Screening techniques: Drug likeness screening, Concept of
pharmacophore mapping and pharmacophore based Screening,
Molecular docking: Rigid docking, flexible docking, manual docking,
Docking based screening. De novo drug design.
UNIT-IV
Informatics & Methods in drug design
Introduction to Bioinformatics, chemoinformatics. ADME databases,
chemical, biochemical and pharmaceutical databases.

UNIT-V
Molecular Modeling: Introduction to molecular mechanics and quantum
mechanics.Energy Minimization methods and Conformational Analysis,
global conformational minima determination.

Recommended Books (Latest Editions)

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.
 BP-804T (D) : CELL AND MOLECULAR BIOLOGY (Theory)

Scope:
 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.

Objectives: Upon completion of the subject student shall be able to;

 Summarize cell and molecular biology history. 
 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
Course content:
Unit I
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)

Unit II
DNA and the Flow of Molecular Information
DNA Functioning
DNA and RNA
Types of RNA
Transcription and Translation

Unit III
Proteins: Defined and Amino Acids
Protein Structure
 Regularities in Protein Pathways
Cellular Processes
Positive Control and significance of Protein Synthesis
Unit IV
Science of Genetics
Transgenics and Genomic Analysis
Cell Cycle analysis
Mitosis and Meiosis
Cellular Activities and Checkpoints

Unit V
Cell Signals: Introduction
Receptors for Cell Signals
Signaling Pathways: Overview
Misregulation of Signaling Pathways
Protein-Kinases: Functioning

Recommended Books (latest edition):

W.B. Hugo and A.D. Russel: Pharmaceutical Microbiology, Blackwell
Scientific publications, Oxford London.
th
Prescott and Dunn., Industrial Microbiology, 4 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.
 BP- 804T( E). DIETARY SUPPLEMENTS AND NUTRACEUTICALS(Theory)

Scope :

This subject covers foundational topic that are important for understanding the need
and requirements of dietary supplements among different groups in the population.

Objective:

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.
UNIT I

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
UNIT II

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.
UNIT III

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..
UNIT IV

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

UNIT V

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.

References:

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).
nd
Prescription for Nutritional Healing by James F.Balch and Phyllis A.Balch 2 Edn.,
Avery Publishing Group, NY (1997).
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
 BP-804T (F) PHARMACEUTICAL PRODUCT DEVELOPMENT (Theory)

Unit-I
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

Unit-II
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

Unit-III
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

Unit-IV
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.

Unit-V
Selection and quality control testing of packaging materials for pharmaceutical product
development- regulatory considerations.
Recommended Books (Latest editions)
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.
 BP-805(P) PRACTICE SCHOOL (Practical)

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.