About the Book:

“Pharmaceutical Research Methodology and Bio-Statistics: Theory and Practice” is aimed in understanding the fundamental concepts of developing a research bent of mind by careful planning, execution, collection of data and analyzing for statistical significance. The book is aimed at B. Pharm, Pharm D, Pharm D (PB), M. Pharm, allied course students, researchers at the academic and industry levels, Ph. D scholars, policy makers, regulators etc.

Key Features:

            ·      Exclusively relating to pharmaceuticals

            ·      Conventional English

            ·      Distinguishing statistics and bio-statistics

            ·      How to identify a problem, plan for research and execute the idea

            ·      Chemical abstract literature search

            ·      Anatomy of a research paper

            ·      Compare and contrast of research proposal, research report, research paper, patent document, synopsis

            ·      Concept of meta-analysis to resolve research ambiguities

            ·      Classification of clinical study designs

            ·      Approaches of developing a research methodology

            ·      Abstract scaling concepts and techniques for developing questionnaire

            ·      Data collection, cleansing, presenting

            ·      How to overcome missing data

            ·      Introduction to Probability, Permutations and Combinations

            ·      Parametric distributions - binomial, poisson, normal, chi-square, student 't', F distributions

            ·      Extra information on Bernoulli Distribution and Chebyshev’s Theorem

            ·      Role of Type I and Type II errors, Power, sample size, confidence level, confidence interval, confidence limits

            ·      How to judge whether data upon analysis is statistical significant or not

            ·      Developing hypothesis as null, alternate and how to draw conclusion after conducting suitable statistical test

            ·      Non-parametric statistical test - Run, Sign, Wilcoxon Signed rank, Wilcoxon rank sum tests

            ·      Parametric, Non-parametric ANOVAs (1-way with multiple comparisons, 2-way, cross over, 3-way)

            ·      Step wise Parametric and non-parametric problem solving

            ·      Statistical softwares like SPSS, SAS, Minitab, Epi-info with screenshots

            ·      Applications of linear regression and correlation coef ficient relating to pharmaceuticals

            ·      Appended with Multi-linear Regression Analysis (Mathematical and Excel Calculation)

            ·      Fundamental concepts of book keeping, accountancy, emphasizing on making entries in journal and ledger

            ·      Basic terminology of epidemiology

            ·      Inventory control, role of computers, parenteral Admixture

            ·      Developing a management report

Contents:

1.    Introduction to Research and Bio-statistics in Pharmaceuticals

2.    Information Sources

3.    Literature Search

4.    Meta-Analysis

5.    Distinguishing Research Proposal, Research Report, Research Paper, Patent Document and Synopsis

6.    Detailed Contents of a Research Paper

7.    Clinical Trials and Clinical Study Design

8.    Principles of Experimental Designs

9.    Need of Sampling and Sampling Techniques

10. Measurement and Scaling

11. Scaling Techniques

12. Introduction to Presentation of Data and Missing Data13. Probability, Permutations and Combinations

14. Statistics, Bio-statistics and their Relation to Distribution Trends

15. Measures of Central Tendency and Variability

16. Standard Error, Confidence Level/Confidence Interval/Confidence Limits, Statistical Errors, Hypothesis

17. Student ‘t’ Distribution and its Applications

18. Chi-square Distribution

19. F-Distribution (Variance Ratio) and ANOVA

20. Non-Parametric Statistical Tests

21. Sample Size Determination

22. Introduction to Epidemiology

23. Introduction to SAS, SPSS, Epi Info and Minitab

24. Applications of SPSS, Epi Info and Minitab Softwares (Screen Shots)

25. Linear Regression, Correlation and Correlation Coefficient

26. Inventory Control

27. Accountancy and Book Keeping

28. Management Report

29. Role of Computers in Healthcare System

30. Parenterals Admixture

About the Author:

Bayya Subba Rao completed both B. Pharm and M. Pharm from College of Pharmaceutical Sciences, Manipal. He completed P.G.Diploma in Patent Laws from NALSAR University of Law, Hyderabad. He was awarded with Doctorate in Pharmaceutical Sciences degree from Andhra University, Visakhapatnam.

           During his 24 years of career he was involved in basic research, process research, teaching, government service at various levels as scientist-II, research chemist, lecturer, associate professor, I/C Principal, patent analyst. He has to his credit over 45 research, review articles published in national journals and has five copyrights.

           During his career he was involved in synthesis of new chemical entities, synthesis of drug metabolites and chemical process developments. He developed a process that was later patent applied and abandoned.

           He was involved in teaching Bio-Statistics and research methodology relating to pharmaceuticals to students at the B.Pharm, Pharm.D and M.Pharm levels.