Description
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 US, Europe and India in 20 chapters. Special emphasis is given to Pharmacovigilance methods and 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 clinical research industry and personnel. The subject is presented in a simple, lucid and easily understandable way in 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.
Author: Kpr Chowdary
Publisher: Pharmamed Press
Published: 11/01/2021
Pages: 286
Binding Type: Hardcover
Weight: 1.56lbs
Size: 9.25h x 7.50w x 0.69d
ISBN13: 9789391910518
ISBN10: 9391910513
BISAC Categories:
- Medical | Pharmacology
- Medical | Pharmacy
- Medical | Clinical Medicine
This title is not returnable