Prasad Prasad Mohanta
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. 3
