SEMESTER VIII

BP801T. BIOSTATISITCS AND RESEARCH METHODOLOGY (Theory)

45 Hours

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 10 Hours
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 10 Hours
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, the 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 10 Hours
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 08 Hours
Blocking and confounding system for Two-level factorials
Regression modelling: Hypothesis testing in Simple and Multiple regression models
Introduction to Practical components of Industrial and Clinical Trials Problems: Statistical Analysis
Using Excel, SPSS, MINITAB®, DESIGN OF EXPERIMENTS, R - Online Statistical Software to Industrial
and Clinical trial approach

Unit-V 07 Hours
Design and Analysis of experiments:
Factorial Design: Definition, 22, 23design. Advantage of factorial design
Response Surface methodology: Central composite design, Historical design, Optimization Techniques
 BIOSTATISITCS AND RESEARCH METHODOLOGY
Recommended Books (Latest edition):
1. Pharmaceutical statistics- Practical and clinical applications, Sanford Bolton,
publisher Marcel Dekker Inc. NewYork.
2. Fundamental of Statistics – Himalaya Publishing House- [Link]
3. Design and Analysis of Experiments –PHI Learning Private Limited, R.
Pannerselvam,
4. Design and Analysis of Experiments – Wiley Students Edition,
Douglas and C. Montgomery
 SEMESTER VIII

BP 802T SOCIAL AND PREVENTIVE PHARMACY

45 Hours

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 issues related 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 to health and pharmaceutical issues.

Course content

Unit-I 10 Hours
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 10 Hours
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 10 Hours
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 08 Hours
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 07 Hours
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.
 SOCIAL AND PREVENTIVE PHARMACY
Recommended Books (Latest edition):
1. Short Textbook of Preventive and Social Medicine, Prabhakara GN, 2nd Edition, 2010, ISBN:
9789380704104, JAYPEE Publications
2. Textbook of Preventive and Social Medicine (Mahajan and Gupta), Edited by Roy Rabindra Nath, Saha
Indranil, 4th Edition, 2013, ISBN: 9789350901878, JAYPEE Publications
3. Review of Preventive and Social Medicine (Including Biostatistics), Jain Vivek, 6th Edition, 2014, ISBN:
9789351522331, JAYPEE Publications
4. Essentials of Community Medicine—A Practical Approach, Hiremath Lalita D, Hiremath Dhananjaya A,
2nd
Edition, 2012, ISBN: 9789350250440, JAYPEE Publications
5. Park Textbook of Preventive and Social Medicine, K Park, 21st Edition, 2011, SBN-14: 9788190128285,
BANARSIDAS BHANOT PUBLISHERS.
6. Community Pharmacy Practice, Ramesh Adepu, BSP publishers, Hyderabad
Recommended Journals:
1. Research in Social and Administrative Pharmacy, Elsevier, Ireland
 SEMESTER VIII

BP804 ET. PHARMACEUTICAL REGULATORY SCIENCE (Theory)

45 Hours

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;

1. Know about the process of drug discovery and development
2. Know the regulatory authorities and agencies governing the manufacture and sale of pharmaceuticals
3. Know the regulatory approval process and their registration in Indian and international markets

Course content:

Unit-I 10 Hours
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 10 Hours
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 10 Hours
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 08 Hours
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 07 Hours
Regulatory Concepts
Basic terminology, guidance, guidelines, regulations, Laws and Acts, Orange book, Federal Register, Code of
Federal Regulatory, Purple book
 PHARMACEUTICAL REGULATORY SCIENCE
Recommended books (Latest edition):
1. Drug Regulatory Affairs by Sachin Itkar, Dr. N.S. Vyawahare, Nirali Prakashan.
2. 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.
3. New Drug Approval Process: Accelerating Global Registrations By Richard A Guarino, MD, 5th edition,
Drugs and the Pharmaceutical Sciences,Vol.190.
4. Guidebook for drug regulatory submissions / Sandy Weinberg. By John Wiley & Sons. Inc.
5. FDA Regulatory Affairs: a guide for prescription drugs, medical devices, and biologics /edited by Douglas J.
Pisano, David Mantus.
6. Generic Drug Product Development, Solid Oral Dosage forms, Leon Shargel and Isader Kaufer, Marcel
Dekker series, Vol.143
7. Clinical Trials and Human Research: A Practical Guide to Regulatory Compliance By Fay A. Rozovsky and
Rodney K. Adams
8. Principles and Practices of Clinical Research, Second Edition Edited by John I. Gallin and Frederick P.
Ognibene
9. Drugs: From Discovery to Approval, Second Edition By Rick Ng
 SEMESTER VIII

Elective course on PHARMACEUTICAL PRODUCT DEVELOPMENT

No of Hours: 3 Tutorial:1 Credit points:4

Unit-I 10 Hours
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 10 Hours
An advanced study of Pharmaceutical Excipients in pharmaceutical product development with a special
reference to the following categories
i. Solvents and solubilizers
ii. Cyclodextrins and their applications
iii. Non - ionic surfactants and their applications
iv. Polyethylene glycols and sorbitols
v. Suspending and emulsifying agents
vi. Semi solid excipients

Unit-III 10 Hours
An advanced study of Pharmaceutical Excipients in pharmaceutical product development with a special
reference to the following categories
i. Tablet and capsule excipients
ii. Directly compressible vehicles
iii. Coat materials
iv. Excipients in parenteral and aerosols products
v. Excipients for formulation of NDDS
Selection and application of excipients in pharmaceutical formulations with specific industrial applications

Unit-IV 08 Hours
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 07 Hours
Selection and quality control testing of packaging materials for pharmaceutical product development regulatory
considerations.
 PHARMACEUTICAL PRODUCT DEVELOPMENT
Recommended Books (Latest editions)
1. Pharmaceutical Statistics Practical and Clinical Applications by Stanford Bolton, Charles Bon; Marcel
Dekker Inc.
2. Encyclopaedia of Pharmaceutical Technology, edited by James swarbrick, Third Edition,Informa Healthcare
publishers.
3. Pharmaceutical Dosage Forms, Tablets, Volume II, edited by Herbert A. Lieberman and Leon Lachman;
Marcel Dekker, Inc.
4. 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 [Link]. 2013.
5. Martin’s Physical Pharmacy and Pharmaceutical Sciences, Fifth Edition, edited by Patrick J. Sinko, BI
Publications Pvt. Ltd.
6. Targeted and Controlled Drug Delivery, Novel Carrier Systems by S. P. Vyas and R. [Link], CBS
Publishers and Distributors Pvt. Ltd, First Edition 2012.
7. Pharmaceutical Dosage Forms and Drug Delivery Systems, Loyd V. Allen Jr., Nicholas [Link], Howard
C. Ansel, 9th Ed. 40
8. Aulton’s Pharmaceutics – The Design and Manufacture of Medicines, Michael E. Aulton,3rd Ed.
9. Remington – The Science and Practice of Pharmacy, 20th Ed.
10. Pharmaceutical Dosage Forms – Tablets Vol 1 to 3, A. Liberman, Leon Lachman and Joseph B. Schwartz
11. Pharmaceutical Dosage Forms – Disperse Systems Vol 1 to 3, H.A. Liberman, Martin, M.R and Gilbert S.
Banker.
12. Pharmaceutical Dosage Forms – Parenteral Medication Vol 1 & 2, Kenneth E. Avis and H.A. Libermann.
13. Advanced Review Articles related to the topics.