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CRC Press Statistical Design and Analysis of Stability Studies - CRC Press

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Description

Statistical Design and Analysis of Stability Studies is a comprehensive guide to the principles and methodologies essential for designing and analysing stability studies in the pharmaceutical industry. This book addresses a critical area of drug safety and quality assurance, examining how stability data directly impacts expiration dates and regulatory compliance. The work demonstrates why the US Food and Drug Administration identified inadequate stability data as a leading cause of drug recalls, making this resource invaluable for pharmaceutical professionals, biostatisticians, and quality assurance teams. By combining theoretical foundations with practical applications, the book equips readers with the knowledge needed to characterise drug product degradation, estimate shelf life accurately, and navigate regulatory requirements. Part of the Chapman and Hall/CRC Biostatistics Series, this volume bridges the gap between statistical theory and real-world pharmaceutical applications, offering guidance for developing robust stability protocols that protect public health and maintain product integrity.

Key Features

Part of the Chapman and Hall/CRC Biostatistics Series, providing expert-level content on stability study methodology for pharmaceutical professionals.

Addresses FDA compliance by explaining how stability studies support accurate expiration date determination and prevent drug recalls.

Covers fundamental principles and practical methodologies for designing stability studies that characterise drug product degradation patterns.

Guides biostatisticians and quality assurance teams through estimating drug shelf life using rigorous statistical approaches.

Integrates regulatory requirements with statistical analysis techniques to ensure pharmaceutical products meet safety and quality standards.

Product Specifications

Format
hardcover
Domain
Amazon UK
Release Date
30 May 2007
Listed Since
05 January 2007

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No barcode data available

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