Handbook of Stability Testing in Pharmaceutical Development

Language: English

Published by Springer, Humana Nov 2010, 2010

1441927565 / 9781441927569

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Seller: BuchWeltWeit Ludwig Meier e.K., Bergisch Gladbach, GermanyBuchWeltWeit Ludwig Meier e.K.

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This item is printed on demand - it takes 3-4 days longer - Neuware -A COMPREHENSIVE AND PRACTICAL GUIDE TO STABILITY TESTING IN PHARMACEUTICAL DEVELOPMENTStability 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. 408 pp. Englisch.

Seller Inventory # 9781441927569

Title
Handbook of Stability Testing in Pharmaceutical Development
Author
Kim Huynh-Ba
Publisher
Springer, Humana Nov 2010
Publication year
2010
Condition
Neu
Binding
Taschenbuch
Language
English
ISBN 10
1441927565
ISBN 13
9781441927569
Item weight
616 grams
Dimensions
235x155x23 mm

BuchWeltWeit Ludwig Meier e.K.

Bergisch Gladbach, Germany

5-star seller

AbeBooks seller since January 11, 2012

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BuchWeltWeit Ludwig Meier e.K.

Germany