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bokomslag Pharmaceutical Regulatory Affairs

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280 sidor
2026

This book provides concepts, procedures, guidelines, and regulatory affairs in the drug development. It begins with a detailed overview of the drug development lifecycle, from initial discovery and preclinical research to clinical trials and market approval, addressing scientific, regulatory, and ethical considerations at each stage. The book covers the evolution of global trade agreements like GATT and the WTO's impact on pharmaceuticals, highlighting issues surrounding pharmaceutical patents and intellectual property rights. It discusses the importance of the SUPAC guidelines in ensuring quality and consistency in drug manufacturing post-approval and examines the WHO's guidelines on technology development and transfer. The fundamentals of regulatory affairs are covered, emphasizing the roles and responsibilities of regulatory professionals. The book provides an in-depth look at regulatory frameworks of major agencies worldwide, including the CDSCO in India, the FDA in the U.S., the EMA in the EU, the TGA in Australia, the PMDA in Japan, Health Canada, and regulatory authorities in emerging markets. It also addresses the international regulatory landscape for medical devices and reviews foundational pharmaceutical regulations. Additionally, it explores regulatory guidelines for clinical testing, including the roles and responsibilities under pharmaceutical legislation, principles of bioethics and biosafety, the digital transformation in clinical trials, and the critical role of pharmacovigilance. The book concludes with an examination of the global regulatory scenario for pharmaceutical excipients, providing a detailed roadmap through the complexities of drug development, regulatory compliance, and global standards. This book is valuable for professionals, researchers, and students of pharmaceutical sciences.

Författare: Nimisha Srivastava, Neeraj Mishra, Sumel Ashique, Bharanitharan Rajendran
Format: Inbunden
ISBN: 9781032944876
Språk: Engelska
Antal sidor: 280
Utgivningsdatum: 2026-01-02
Förlag: Taylor & Francis Ltd

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