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This handbook is the first to cover all aspects of stability testing in pharmaceutical development. Written by a group of international experts, the book presents a scientific understanding of regulations and balances methodologies and best practices.
This handbook addresses the critical need for comprehensive stability testing in pharmaceutical development. Written by a group of international experts, it provides a scientific understanding of the complex regulatory landscape, balancing these requirements with practical methodologies and established best practices for ensuring drug product quality and safety over time.
This handbook is regarded as a foundational text for professionals involved in pharmaceutical development, offering a thorough compilation of regulations, methodologies, and best practices. Its comprehensive approach, authored by international experts, ensures a robust understanding of stability testing crucial for drug quality and safety. The book is likely to be valued for its balance between scientific rigor and practical application, serving as an authoritative reference for researchers, quality control personnel, and regulatory affairs specialists.
Page Count:
389
Publication Date:
2010-11-23
Publisher:
Springer New York
ISBN-10:
1441927565
ISBN-13:
9781441927569
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