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GUJARAT TECHNOLOGICAL UNIVERSITY
M.Pharm
SEMESTER: III
Subject Name: RESEARCH METHODOLOGY, BIOSTATISTICS AND IPR
Subject Code: MRM301T
Sr Course Contents Total Hrs
No
1 General Research Methodology 12
General Research Methodology: Research, objective, requirements, practical
difficulties, Review of literature: Use of Library, books and journals-
Medlines-Internet, and reprints of articles as a source for Literature survey.
Selecting a problem and preparing Research proposals.
The Research Report, Paper writing/ thesis writing, Different parts of the
Research paper/Thesis
Presentation oral/poster presentation) Importance, types, different skills,
content, format of model, Poster, Gestures, eye contact, facial expressions,
stage fright, volume- pitch, speed, pause & language, Visual aids & seating,
Questionnaire.
Sources for procurement research grants –National/ international agencies,
Government and private bodies
2 Experimental Design (15 hours) 15
Terminology and definitions related to experimental design
Study design, types of studies, strategies to eliminate errors/bias, controls,
randomization, crossover design, placebo, blinding techniques
Sampling Designs: Introduction, types of sample designs, steps, criteria of
selection, characteristics, random sampling, drop outs.
Advantage and disadvantage of conventional design over experimental
design.
Basic steps in experimental design.
Screening Designs:
Screening of factors, General properties for independent factor
selected for experimental design, Fractional factorial design(FFD):
Purpose advantage and disadvantage of fractional factorial design,
Concept of Aliased Effects and Design Aliasing Structure and
constructing FFD
Analysis of fractional factorial design: Concept of Design
Resolution for FFD Case study of factorial design
Plackett–Burman designs: Purpose advantage and disadvantage and
construction of matrix , Comparison between placket-Burman and FFD
design, Case study
Full factorial design
Optimization techniques and various method of optimization
Introduction to contour plots
Introduction of repose surface design: Classification
Characteristic of design
Matrix and analysis of design with case study
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Evolution of full and reduced mathematical models in experimental
designs
Central composite designs
Taguchi and mixture design
Application of experimental design in pharmacology for reduction of animal
3 Biostatistics 8
Definition, application, statistical tests of significance, type of significance
tests, parametric tests(students “t” test, ANOVA, Correlation coefficient,
regression), non-parametric tests (wilcoxan rank tests, analysis of variance,
correlation, chi square test, Kruskal Wallis test, Mann Whitney U test), null
hypothesis, P values, degree of freedom, interpretation of P values, post hoc
tests for parametric and non-parametric data (Dunnett’s test, Tukey’s test,
Dunn’s test)
4 Regulatory perspectives of Medical research 10
History of medical research (Nuremberg code, The declaration of Helsinki),
initiation of ICH-GCP guidelines, advantages of ICH-GCP, core principles
of ICH -GCP guidelines , Ethical Committee: Institutional Review Board,
Ethical Guidelines by ICMR for Biomedical Research and Human
Participants(ethical issues- informed consent process, confidentiality,
payments, conflict of interest, vulnerable participants), Schedule Y,
Preparation of clinical protocol, Investigator Brochure, Case Report Forms
5 CPCSEA guidelines for laboratory animal facility 5
Objective and functions of IAEC, background and process of evolution of
guidelines, statutory provisions regarding scientific experiments of animals,
CPCSEA guidelines for animal experimentation and laboratory animal
facility 2015, care and handling of animals, concept of 4 R, protocol
preparation for Preclinical studies (Form B)
6 IPR and Patents 10
Patents: Definition, Need for patenting, scope and importance of patents,
Types of Patents, Condition to be satisfied by an invention to be patentable,
Introduction to patent search and important websites, The essential elements
of patents, Guidelines for preparations of laboratory notebook, non-
obviousness in patents, Drafting of patent claims, important patent related
websites. Copyrights and Trademark: Brief introduction to trademark
protection and WTO patents, Introduction to “The Patents Act 1970” and
“The Patents Rule 2003”, with special emphasis on the forms to be submitted
along with a patent application
REFERENCES:
1. Research Methodology by C.R. Kothari
2. Compendium of CPCSEA 2018
3. Presentation skills – Michael Hallon- Indian Society for Institute education
4. Pharmaceutics Statistics by Sanford Bolton, Charles Bon
5. Patent laws , By P. Narayan. Eastern law house publications
6. Pharmaceutical Experimental Design By Gareth Lewis and Didier Mathieu
7. www. ipindia.nic.in, www.uspto.gov
8. www.cpcsea.nic.in
9. www.icmr.nic.in