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FDA关于破坏实验的一些最新看法和要求
FDA 关于破坏实验的一些最新看法和要求
FDA Perspectives: Scientific Considerations of Forced Degradation Studies in ANDA
Submissions
The author outlines the scientific aspects of forced degradation studies that should be considered
in relation to ANDA submissions.
May 2, 2012
By:Ragine Maheswaran
Pharmaceutical Technology
Volume 36, Issue 5, pp. 73-80
Forced degradation is synonymous with stress testing and purposeful degradation. Purposeful
degradation can be a useful tool to predict the stability of a drug substance or a drug product with
effects on purity, potency, and safety. It is imperative to know the impurity profile and behavior of
a drug substance under various stress conditions. Forced degradation also plays an important role
in the development of analytical methods, setting specifications, and design of formulations under
the quality-by-design (QbD) paradigm. The nature of the stress testing depends on the individual
drug substance and the type of drug product (e.g., solid oral dosage, lyophilized powders, and
liquid formulations) involved (1).
The International Conference on Harmonization (ICH) Q1B guideline provides guidance for
performing photostability stress testing; however, there are no additional stress study
recommendations in the ICH stability or validation guidelines (2). There is also limited
information on the details about the study of oxidation and hydrolysis. The drug substance
monographs of Analytical Profiles of Drug Substances and Excipients provide some information
with respect to different stress conditions of various drug substances (3).
The forced degradation information provided in the abbreviated new drug application (ANDA)
submissions is often incomplete and in those cases defici
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