Handbook of Stability Testing in Pharmaceutical Development

Idioma: inglés

Editorial: Springer, Springer Nov 2008, 2008

0387856269 / 9780387856261

Librería: BuchWeltWeit Ludwig Meier e.K., Bergisch Gladbach, AlemaniaBuchWeltWeit 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.

N° de ref. del artículo 9780387856261

Título
Handbook of Stability Testing in Pharmaceutical Development
Autor
Kim Huynh-Ba
Editorial
Springer, Springer Nov 2008
Año de publicación
2008
Estado
Neu
Encuadernación
Buch
Idioma
inglés
ISBN 10
0387856269
ISBN 13
9780387856261
Peso del artículo
850 gramos
Dimensiones
241x160x26 mm

BuchWeltWeit Ludwig Meier e.K.

Bergisch Gladbach, Alemania

Vendedor de 5 estrellas

Vendedor de AbeBooks desde 11 de enero de 2012

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BuchWeltWeit Ludwig Meier e.K.

Alemania