ICH M9 - reverse engineering? [Regulatives / Guidelines]

posted by dshah  – India, 2020-09-30 09:27 (1720 d 15:46 ago) – Posting: # 21951
Views: 2,154

Dear Marta!

Pls find the recent presentation by FDA on - From General Q1/Q2 Inquiries to Supporting Complex Excipient Sameness. It can be downloaded from - https://sbiaevents.com/files2/Innov-2020-Day-1.zip and see- D1S14-Kozak. It will be useful for BCS based biowaiver approach as well.

Regards,
Dshah

Complete thread:

UA Flag
Activity
 Admin contact
23,424 posts in 4,927 threads, 1,673 registered users;
20 visitors (0 registered, 20 guests [including 14 identified bots]).
Forum time: 01:13 CEST (Europe/Vienna)

Law is mind without reason.    Aristotle

The Bioequivalence and Bioavailability Forum is hosted by
BEBAC Ing. Helmut Schütz
HTML5