Volume 2: Comprehensive Guide to Pharmaceutical Regulatory Affairs: Global Regulations and Advanced Topics - Softcover

Veerareddy Prabhakar Reddy; Muralidhar Rao Akkaladevi

 
9798895567074: Volume 2: Comprehensive Guide to Pharmaceutical Regulatory Affairs: Global Regulations and Advanced Topics
Softcover
ISBN 13: 9798895567074
Verlag: Notion Press, 2024

Inhaltsangabe

Comprehensive Guide to Pharmaceutical Regulatory Affairs: Global Regulations and Advanced Topics by Veerareddy Prabhakar Reddy and Muralidhar Rao Akkaladevi is an essential resource for M.Pharm, B.Pharm students, industry professionals, and regulatory experts. This book is meticulously structured into 20 comprehensive chapters, offering in-depth insights into critical areas of pharmaceutical regulatory affairs.

Key topics include the clinical drug development process, with detailed coverage of phases from Phase 0 to Phase IV, as well as ethics in clinical research, exploring historical perspectives and modern ethical challenges. It also dives into regulations governing clinical trials across major regions like India, the USA, the EU, and Japan.

Readers will find valuable information on USA, Australian, and European Union regulations, as well as emerging markets such as ASEAN, GCC, and CIS countries. The book also covers the regulatory aspects of drugs, cosmetics, herbals, biologicals, medical devices, and food and nutraceuticals. Topics like intellectual property rights (IPR) and quality management systems ensure readers are equipped with knowledge on patents, data exclusivity, and Total Quality Management.

This guide also examines future trends in pharmaceutical regulatory affairs, offering insight into innovations and emerging regulatory practices. Ideal for professionals and students alike, this book serves as a vital reference in the global regulatory landscape.

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Verlag
Notion Press
Erscheinungsdatum
2024
Sprache
Englisch
ISBN 13 
9798895567074
Einband
Taschenbuch
Anzahl der Seiten
498
Kontakt zum Hersteller
Nicht verfügbar
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