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- ÉditeurBioGreen Publication
- ISBN 10 9390211557
- ISBN 13 9789390211555
- ReliureUnknown Binding
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A Textbook of Clinical Research and Pharmacovigilance
Edité par
PharmaMed Press / BSP Books
(2021)
ISBN 10 : 9390211557
ISBN 13 : 9789390211555
Neuf
Soft cover
Quantité disponible : 5
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Description du livre Soft cover. Etat : New. 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. N° de réf. du vendeur 139433
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