FDA关于破坏实验的一些必威体育精装版看法和要求.pdf

FDA 关于破坏实验的一些必威体育精装版看法和要求 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