NDLI: The Stability Testing Program

Content Provider	Scilit
Author	Geigel, Maria A.
Copyright Year	2003
Description	Stability testing and ancillary analytical work are undoubtedly the most resourceintensive activities in the chemistry, manufacturing, and controls (CMC) area of drug development. Stability studies are required in the preclinical phase, throughout the clinical trials, in support of regulatory registra-tions, in support of changes to the approved product, and for as long as the product is marketed. Stability data are a key element in assuring the quality of both the active pharmaceutical ingredient (API) and the formulated drug product during all phases of development and marketing. Book Name: Compliance Handbook for Pharmaceuticals, Medical Devices, and Biologics
Related Links	https://content.taylorfrancis.com/books/download?dac=C2010-0-30605-0&isbn=9780429216404&doi=10.1201/9780203026960-10&format=pdf
Ending Page	219
Page Count	35
Starting Page	185
DOI	10.1201/9780203026960-10
Language	English
Publisher	Informa UK Limited
Publisher Date	2003-12-09
Access Restriction	Open
Subject Keyword	Book Name: Compliance Handbook for Pharmaceuticals, Medical Devices, and Biologics Pharmacology and Pharmacy Manufacturing Api Cmc Pharmaceutical Stability Testing Ingredient Ancillary Tions Undoubtedly Assuring
Content Type	Text
Resource Type	Chapter

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