A Textbook of Clinical Research and Pharmacovigilance. E-book. Formato EPUB K. P. R. Chowdary   -  Pharmamed Press, 2021  - 

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 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 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.

A Textbook of Pharmaceutical Quality Assurance. E-book. Formato EPUB K. P. R. Chowdary   -  Bsp Books, 2020  - 

This book describes all aspects of pharmaceutical quality assurance needed for an industrial pharmacist and the book covers the entire syllabus prescribed by PCI for the subject of pharmaceutical quality assurance in B Pharm and M Pharm programs under new uniform regulations. This book has been designed to make the subject more interesting, more comprehensive and easy to grasp. Huge information on the subject is presented in condensed and cohesive form. Current updated guidelines and regulations related to drug development, manufacture and supply are included. As such the book provides latest knowledge on the subject. Special emphasis is given on topics like quality management, quality assurance and quality control, TQM, QbD, cGMP, GLP, ISO, ICH guidelines, stability testing, process validation, calibration and validation of analytical equipments and methods, packaging material control, ware housing and materials management. This book is ideal for B.Pharm, M.Pharm and Pharm.D. students.