ICH M9 - reverse engineering? [Regulatives / Guidelines]

posted by dshah – India, 2020-09-30 07:27 (203 d 09:37 ago) – Posting: # 21951
Views: 364

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:

Activity
 Admin contact
21,419 posts in 4,475 threads, 1,510 registered users;
online 15 (0 registered, 15 guests [including 7 identified bots]).
Forum time: Wednesday 17:05 CEST (Europe/Vienna)

In the Middles Ages the lingua franca of science was Latin.
Nowadays the language of science is bad English.    Anonymous

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