Author:
Edition: Softcover reprint of hardcover 1st ed. 2009
Publisher: Springer
Binding: Paperback
ISBN: 1441927565
Handbook of Stability Testing in Pharmaceutical Development: Regulations, Methodologies, and Best Practices
This handbook is the first to cover all aspects of stability testing in pharmaceutical development. Medical books Handbook 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 Medical books Handbook of Stability Testing in Pharmaceutical Development:. Handbook of Stability Testing in Pharmaceutical Development: Regulations, Methodologies, and Best Practices by Huynh-Ba, Kim [Hardcover]
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Handbook of Stability Testing in Pharmaceutical Development: Regulations, Methodologies, and Best Practices by Huynh-Ba, Kim [Hardcover]
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Store Search search Title, ISBN and Author Handbook of Stability Testing in Pharmaceutical Development Estimated delivery 3-12 business days Format Paperback Condition Brand New This handbook is the first to cover all aspects of stability testing in pharmaceutical development. Written by a group of international experts, the book presents a scientific understanding of regulations and balances methodologies and best practices. Publisher Description This handbook is the first to cover all aspects
This work provides 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.
Medical Book Handbook 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.
