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BPHARMASyllabus SEM 8
BPHARMASyllabus SEM 8
BPHARMASyllabus SEM 8
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.
Course content:
Unit-I 10 Hours
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, 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 8 Hours
Unit-V 7Hours
Hours: 45
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: 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
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.
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.
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
Rabindra Nath, Saha Indranil, 4th 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
Recommended Journals:
130
BP803ET. PHARMACEUTICAL MARKETING (Theory)
45 Hours
Scope:
The pharmaceutical industry not only needs highly qualified researchers, chemist,
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. Sales & Marketing which grooms the people for taking a challenging role in
Sales and Product management.The career in product management starts from having
hands on experience in sales and marketing only.
Unit I 10 Hours
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 10 Hours
Product decision:
Meaning, Classification, product line and product mix decisions, product life
cycle,product portfolio analysis; product positioning; New product decisions; Product
branding, packagingand labeling decisions, Product management in pharmaceutical
industry.
131
Unit IV 10 Hours Pharmaceutical marketing channels:
Unit V 10 Hours
Pricing:
132
BP804 ET: PHARMACEUTICAL REGULATORY SCIENCE (Theory)
45Hours
Scope: This course is designed to impart the fundamental knowledge on the regulatory
requirements for approval of new drugs, drug products in regulated countries like US,
EU, Japan, Australia and Canada. It prepares the students to learn in detail on the
regulatory requirements, documentation requirements, and registration procedures for
marketing the drug products in regulated countries.
Unit I 10Hours
Unit II 10Hours
133
Procedure for export of pharmaceutical products, Technical documentation, Drug Master
Files (DMF), Common Technical Document (CTD), electronic Common Technical
134
Document (eCTD), ASEAN Common Technical Document (ACTD)research.
Unit IV 08Hours
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 07Hours
Regulatory Concepts
Basic terminologies, guidance, guidelines, regulations, laws and acts, Orange book,
Federal Register, Code of Federal Regulatory, Purple book
135
BP 805T: PHARMACOVIGILANCE (Theory)
45 hours
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):
ICH guidelines for ICSR, PSUR, expedited reporting, pharmacovigilance planning CIOMS
requirements for ADR reporting
Course Content
Unit I Introducti
o
Introduction to Pharmacovigilance n
History and development of
t
Pharmacovigilance Importance of safety
o
monitoring of Medicine WHO international drug
monitoring programme Pharmacovigilance
a
Program of India(PvPI)
d
136
verse drug reactions Definitions and 10 Hours
classification of ADRs Detection and
reporting
137
Terminologies of adverse medication related
events Regulatory terminologies
Unit II 10 hours
Establishing in a hospital
Vaccine Pharmacovigilance
Vaccination failure
Pharmacovigilance methods
Unit IV 8 Hours
139
Safety data generation
Unit V 7 hours
Paediatrics
Pregnancy and
lactation Geriatrics
CIOMS
CIOMS Working Groups
CIOMS Form
141
http://www.whoumc.org/DynPage.aspx?id=105825&mn1=7347&mn2=7259&mn
3=7297
http://www.ich.org/
http://www.cioms.ch/
http://cdsco.nic.in/
http://www.who.int/vaccine_safety/en/
http://www.ipc.gov.in/PvPI/pv_home.html
142
BP 806 ET. 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.
Unit I 10 hours
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 10 hours
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 II I 10 hours
EU and ICH guidelines for quality control of herbal drugs.
Research Guidelines for Evaluating the Safety and Efficacy of Herbal Medicines
Unit IV 08 hours
141
BP 807 ET. COMPUTER AIDED DRUG DESIGN (Theory)
45 Hours
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 10 Hours
142
UNIT-IV 08 Hours Informatics & Methods in drug design
UNIT-V 07 Hours
Robert GCK, ed., “Drug Action at the Molecular Level” University Prak Press Baltimore.
143
BP808ET: CELL AND MOLECULAR BIOLOGY (Elective subject)
45 Hours
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.
Cell and Molecular Biology: Definitions theory and basics and Applications.
Cell and Molecular Biology: History and Summation.
Theory of the Cell? Properties of cells and cell membrane.
Prokaryotic versus Eukaryotic
Cellular Reproduction
Chemical Foundations – an Introduction and Reactions (Types)
Unit II 10 Hours
144
Regularities in Protein Pathways
Cellular Processes
Positive Control and significance of Protein Synthesis
Unit IV 08 Hours
Science of Genetics
Transgenics and Genomic Analysis
Cell Cycle analysis
Mitosis and Meiosis
Cellular Activities and Checkpoints
Unit V 07 Hours
145
BP809ET. COSMETIC SCIENCE(Theory)
45Hours
UNIT II 10 Hours
Analytical cosmetics: BIS specification and analytical methods for shampoo, skin-
cream and toothpaste.
UNIT IV 08 Hours
147
UNIT V 07 Hours
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.
Cosmetics – Formulations, Manufacturing and Quality Control, P.P. Sharma, 4th
Edition, Vandana Publications Pvt. Ltd., Delhi.
148
BP810 ET.EXPERIMENTAL PHARMACOLOGY
45 Hours
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
Unit –I 08 Hours
Laboratory Animals:
149
Unit –III
Preclinical screening models: for ANS activity, sympathomimetics,
Unit –IV
150
BP 811 ET. ADVANCED INSTRUMENTATION TECHNIQUES
45 Hours
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.
Course Content:
UNIT-I 10 Hours
UNIT-II 10 Hours
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
UNIT-III 10 Hours
Calibration and validation-as per ICH and USFDA guidelines
UNIT-IV 08 Hours
UNIT-V 07 Hours
151
Semester VIII – Elective course on Pharmaceutical Product Development
Unit-II 10 Hours
Unit-III 10 Hours
Unit-IV 08 Hours
Unit-V 07 Hours
Selection and quality control testing of packaging materials for pharmaceutical product
development- regulatory considerations.
152
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.
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