Handbook Of Stability Testing In Pharmaceutical Development by Kim Huynh-Ba

Handbook Of Stability Testing In Pharmaceutical Development



Download Handbook Of Stability Testing In Pharmaceutical Development




Handbook Of Stability Testing In Pharmaceutical Development Kim Huynh-Ba ebook
Language: English
Page: 390
Format: pdf
ISBN: 0387856269, 9780387856261
Publisher: Springer

This handbook is the first 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: (1) Latest regulations for stability testing, including cGMP requirements, ICH guidelines, and global guidances from WHO, ASEAN, EMRO, and other regions. (2) Post-approval considerations and regulatory filing strategies to support a global supply chain. (3) Methodologies, including development of a stability-indicating method, method validation and transfer. Physical stability, non-chromatographic methodologies, and spectroscopic applications are also discussed. (4) Setting specifications, monitoring impurities, and establishing shelf-life of pharmaceutical products. (5) Data management, including stability reports, CMC and discussion of Out-of-Specification (OOS) and Out-of-Trend (OOT). (6) USP-NF testing in support of stability purposes. (7) Current industry best practices on stability operation, validation and calibration of stability chambers including considerations for photo-stability testing. (8) Discussion of matrixing and bracketing to support reduced stability testing. (9) Overview of stability programs for biologics and drug-in-devices pharmaceutical products.

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.

From the Back Cover

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:

Latest regulations for stability testing, including cGMP requirements, ICH guidelines, and global guidances from WHO, ASEAN, EMRO, and other regions.

Post-approval considerations and regulatory filing strategies to support a global supply chain.

Methodologies, including development of a stability-indicating method, method validation, and transfer. This book also discusses physical stability, non-chromatographic methodologies, and spectroscopic applications.

Setting specifications, monitoring impurities, and establishing shelf-life of pharmaceutical products.

Data management, including stability reports, CMC, and discussion of out-of-specification (OOS) and out-of-trend (OOT).

USP-NF testing in support of stability.

Current industry best practices on stability operation, validation, and calibration of stability chambers including considerations for photo-stability testing.

Discussion of matrixing and bracketing to support reduced stability testing.

Overview of stability programs for biologics and drug-in-devices pharmaceutical products.

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.

MORE EBOOKS:
Kingpin: How One Hacker Took Over the Billion-Dollar Cybercrime Underground download ebook
A Modern Day Persuasion ebook download
The Contortionist's Handbook ebook download







Tags: Handbook Of Stability Testing In Pharmaceutical Development ebook pdf epub djvu mobi rar
Handbook Of Stability Testing In Pharmaceutical Development pdf epub djvu free download
Handbook Of Stability Testing In Pharmaceutical Development free ebook pdf epub
Handbook Of Stability Testing In Pharmaceutical Development read online free book
Handbook Of Stability Testing In Pharmaceutical Development cheap ebook for kindle and nook
Kim Huynh-Ba ebooks and audio books
Handbook Of Stability Testing In Pharmaceutical Development download pdf epub rar rapidshare mediafire fileserve 4shared torrent depositfiles scribd