Handbook of Stability Testing in Pharmaceutical Development: Regulations, Methodologies, and Best Practices [Paperback]
Author: Kim Huynh-Ba | Language: English | ISBN: 1441927565 | Format: PDF, EPUB
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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.
- Paperback: 389 pages
- Publisher: Springer; Softcover reprint of hardcover 1st ed. 2009 edition (February 12, 2010)
- Language: English
- ISBN-10: 1441927565
- ISBN-13: 978-1441927569
- Product Dimensions: 0.8 x 6.1 x 9.1 inches
- Shipping Weight: 1.3 pounds (View shipping rates and policies)
- Amazon Best Sellers Rank: #2,291,043 in Books (See Top 100 in Books)
It is the best book on Stability Testing in Pharmaceutical Development I have read so far and, I believe, one of the best existing. Extensive combination of theory, practice, regulations together with description of evaluation methods and best practices make this book very comprehensive to use as a study book as well as a reference book. Extending the topic to adjacent fields of biologics and combination products practically covers almost all aspects of stability considerations in pharmaceutical environmentBy Marina Senko
The stability hand book is comprehensive, organized, thorough, and well written. It covers everything you need to know in establishing and maintaining a stability program. Good overview on regulatory requirements, ICH, WHO, climatic zones, methods, data analysis, SOPs, validation, and calibration. I highly recommend it to anyone involved with stability testing and stablity programs.By John Wesley
John Wesley
Colgate Palmolive Co.
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