Handbook of Stability Testing in Pharmaceutical Development: Regulations, Methodologies, and Best Practices
by Kim Huynh-Ba (9780387856261)

Handbook of Stability Testing in Pharmaceutical Development: Regulations, Methodologies, and Best Practices
 
Kim Huynh-Ba
Release Date: 01 December 2008
Format: Hardback
Pages: 389
Category: Pharmacology
ISBN: 9780387856261
ISBN-10: 0387856269



A COMPREHENSIVE AND PRACTICAL GUIDE TO STABILITY TESTING IN PHARMACEUTICAL DEVELOPMENT

Stability testing is required to demonstrate that a pharmaceutical product meets its acceptance criteria throughout its shelf life and to gain regulatory approval for commercialization. Assessing drug product stability and safety can be quite complicated, and stability profile can impact many functional areas, including analytical testing, formulation development, toxicology, quality, and regulatory affairs.

Handbook of Stability Testing in Pharmaceutical Development: Regulations, Methodologies, and Best Practices is the first volume to cover all aspects of stability testing in pharmaceutical development. It presents a scientific understanding of regulations and balances methodologies and best practices. Comprising 17 chapters, it provides a wealth of resources for pharmaceutical companies, educational institutions, and manufacturing laboratories to use as either a supplementary text for stability training courses or as a reference book for pharmaceutical practitioners.

Topics covered include:



This collective work was written by a group of prominent international experts, who have been directly responsible for instituting industry best practices and establishing the current stability guidelines.

AUD $346.95

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