ICH M9 - reverse engineering? [Regulatives / Guidelines]

posted by dshah – India, 2020-09-30 07:27 (22 d 15:51 ago) – Posting: # 21951
Views: 106

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.


Complete thread:

 Admin contact
21,177 posts in 4,414 threads, 1,474 registered users;
online 4 (1 registered, 3 guests [including 3 identified bots]).
Forum time: Thursday 23:19 CEST (Europe/Vienna)

It is not so much that I have confidence in scientists being right,
but that I have so much in nonscientists being wrong.    Isaac Asimov

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