This book describes all concepts, practices, methods and regulatory guidelines related to clinical research, clinical trials and pharmacovigilance in a simple, lucid and easily understandable manner and covers the entire syllabus prescribed by the Pharmacy Council of India (PCI), New Delhi for Pharm.D and M. Pharm courses.

The book provides a comprehensive knowledge of various aspects such as drug development and approval process, pharmacological and toxicological approaches and methods, pharmaceutical dosage form approaches for drug development, clinical approaches and clinical trials, phases, types, designs and statistical tests of clinical trials, regulatory aspects, GCP as per ICH, WHO, ICMR, Schedule Y and regulatory environment in the US, Europe and India in 20 chapters. Special emphasis is given to the Pharmacovigilance methods and the Pharmacovigilance Programme of India (PvPI).

The book provides a comprehensive knowledge of all aspects of clinical research, clinical trials, GCP guidelines and Pharmacovigilance as per the requirements of the clinical research industry and personnel. The subject is presented in a simple, lucid and easily understandable way in a logical flow for the benefit of pharmacy students as well as industry persons. Latest practices and regulatory guidelines are included and hence the book provides updated knowledge.

This book is ideal for Pharm.D., M.Pharm, and PhD students of Pharmacy and also for research personnel involved in clinical research.