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書名 Methods for stability testing of pharmaceuticals / edited by Sanjay Bajaj, Saranjit Singh
出版項 New York, NY : Humana Press, 2018
國際標準書號 9781493976867
國際標準號碼 10.1007/978-1-4939-7686-7
book jacket
說明 1 online resource (xiv, 358 pages) : illustrations (some color)
text txt rdacontent
computer c rdamedia
online resource cr rdacarrier
系列 Methods in pharmacology and toxicology, 1557-2153
Methods in pharmacology and toxicology
附註 Includes bibliographical references and index
Regulatory guidelines on stability testing and trending of requirements / Dilip Kumar Singh, Saranjit Singh, and Sanjay Bajaj -- Stability dossier : common deficiencies and ways to improve / Paul Marshall -- In silico drug degradation prediction / Mohammed A. Ali, Rachel Hemingway, and Martin A. Ott -- Forced degradation and long-term stability testing for oral drug products : a practical approach / Markus Zimmer -- Model approach for developing stability-indicating analytical methods / Peter Persich, Mario Hellings, Shalu Jhajra, Pradeep Phalke, and Koen Vanhoutte -- Protocols for characterization of degradation products with special emphasis on mutagenic degradation impurities / Steven Hostyn, Peter Persich, Shalu Jhajra, and Koen Vanhoutte -- Stability studies : facility and systems / Ashish Gogia and Sumathi V. Rao -- User requirements and implementation of a risk-based, compliant stability management system / Susan Cleary, Parsa Famili, and Pedro Jorge -- Stability considerations in the life cycle of generic products / Sanjay Bajaj, Srinivasan Rajamani, and Mona Gogia -- Predictive stability testing utilizing accelerated stability assessment program (ASAP) studies / Helen Williams -- Statistical methods and approaches to avoid stability failures of drug product during shelf-life / B.V. Suresh Kumar, Priyank Kulshrestha, and Sandeep Shiromani -- Estimation of stability based on monitoring of shipment and storage / Manuel Zahn -- Stability testing parameters and issues for nanotechnology-based drug products / Kamla Pathak and Satyanarayan Pattnaik -- Stability testing issues and test parameters for herbal medicinal products / Gulshan Bansal, Jasmeen Kaur, Nancy Suthar, Sarabjeet Kaur, and Rahul Singh Negi -- Stability testing considerations for biologicals and biotechnology products / Christine P. Chan
Online resource; title from PDF title page (SpringerLink, viewed May 29, 2018)
鏈接 Print version: Methods for stability testing of pharmaceuticals. New York, NY : Humana Press, 2018 1493976850 9781493976850 (OCoLC)1012306099
主題 Drug stability -- Testing -- Laboratory manuals
Drug Stability
Electronic books
Laboratory Manuals
Alt Author Bajaj, Sanjay, editor
Singh, Saranjit, editor
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