About the Book

The book provides the basic concepts of clinical research relating to clinical trials, bioavailability and bioequivalence study in a simple language. It covers basically Indian Regulation and Requirements for carrying out clinical research in India. However, looking out the need of global clinical trials, the USFDA, ICH and EMEA guidelines /regulations are included in the accompanying CD. The book has the following chapters: Clinical Research in India (Overview), Drug Development Process (Concept to New Drug Application), Clinical Trials (Study Design, Regulation, Ethics, Good Clinical Practice and Post Marketing Surveillance), Quality Assurance (Standard Operating Procedure, Good Laboratory Practice and Data Management), Bioavailability and Bioequivalence and Appendix containing useful websites, list of Contract Research Organizations in India, Example of Informed Consent Form, Guidance for Industries etc.. Considering the fast growth of Clinical Research Activity in India, the book is developed to be a companion for both clinical research professionals and the aspiring professionals who plan to build a career in clinical research. This can be viewed as text book too for Pharm. D. programmes of the Indian Universities.

Contents

1. Clinical Research in India 2. Drug Development Process 3. Clinical Trials 4. Quality Assurance in Clinical Research 5. Bioavailability and Bioequivalence Studies

About the Author

Guru Prasad Mohanta is Professor of Pharmacy at Annamalai University with Master's degree from Jadavpur University and doctoral degree from Annamalai University. He has 25 years of teaching, research and professional experience out of which 02 years as National Technical Officer (Essential Drugs and Medicines) at World Health Organization Country Office for India. He has been trained at several International Courses and Programmes: Drugs and Therapeutics Committee, Rational Drugs Use in the Community, Drug Price Survey, Resource Mobilization, Clinical Pharmacy with support from International Agencies. He was also the coordinator for a peripheral center under World Bank supported National Pharmacovigilance Programme. He has been advocating the rational use of medicines through participating as resource, research, and writing educational column in newspaper. He has been associated with drug management training programmes as organizer as well as resource. He is associated with various professional organizations and is currently the Vice – President of Community Pharmacy Division of Indian Pharmaceutical Association. He has completed several research projects funded by UGC, ICMR, HAI-AP, EPN etc. He has been associated with several Indian Universities and Institutions as member of academic bodies and examiners at various levels. He has good number of publications including the popular articles in peer reviewed scientific journals, professional journals and newspaper. He has visited several countries: Kenya, Switzerland, United Kingdom, Singapore and Australia.