FDA关于ANDA强制降解试验的观点-英文版.pdf

P e e r - r e v i e w e d : r e g u l at o r y Scientific Considerations of Forced degradation Studies in aNda Submissions ragine Maheswaran aBStraCt provide some information with respect to different a well-designed stress study can provide insight in choos- stress conditions of various drug substances (3). ing the appropriate formulation for a proposed product the forced degradation information provided in the prior to intensive formulation development studies. it abbreviated new drug application (aNda) submissions can prevent re-development or re-validation of a stabil- is often incomplete and in those cases deficiencies are ity indicating analytical method. this paper outlines cited. an overview of common deficiencies cited through- the scientific aspects of forced degradation studies that out the chemistry, manufacturing, and controls (CMC) should be considered in relation to aNda submissions. section of the aNdas has been published (4-6). Some examples of commonly cited deficiencies related to forced iNtroduCtioN degradation studies include the following: Forced degradation is synonymous with stress test- • your drug substance does not show any degrada- ing and purposeful degradation. Purposeful degra- tion under any of the stress conditions. Please dation can be a useful tool to predict the stability of repeat stress st