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This handbook addresses the critical need for robust stability testing protocols in pharmaceutical development to ensure drug safety, efficacy, and regulatory compliance. Edited by Kim Huynh-Ba, a recognized expert in the field, the book synthesizes current scientific knowledge and regulatory expectations regarding the stability of pharmaceutical products. It provides a comprehensive overview of the principles, methodologies, and challenges associated with predicting and assessing drug product shelf-life under various environmental conditions.
This handbook is recognized as a vital resource for pharmaceutical scientists, quality control professionals, and regulatory affairs specialists. It is praised for its thorough coverage of stability testing principles and its practical guidance on implementing regulatory requirements. The book is considered an authoritative reference for understanding the complexities of drug product stability and ensuring product quality throughout its lifecycle.
Page Count:
408
Publication Date:
2009-01-01
ISBN-10:
0387856609
ISBN-13:
9780387856605
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