FAQ
Drugs

With regards to validation report and bioanalytical report in Item 3 and 4 of bioequivalence study documentation from PK section on the ANDA Refuse to File (RTF) checklist, how the applicant to confirm if the documentation meets the requirement?

刊登日期:2023-09-17  |  點閱次數 : 318 次 

The documentation requirement of validation report and bioanalytical report can refer to ICH M10 guideline.

 

(中文版)

 


上一筆 With regards to the eligibility of additional strength biowaiver in Item 3 of dis
下一筆 What documents should be submitted for the registration of a drug substance (API)