"Dose or Strength to be Studied" in ICH M13A [Regulatives / Guidelines]

posted by Darborn – Taiwan, 2024-10-08 02:58 (26 d 22:05 ago) – Posting: # 24223
Views: 567

Thanks BEQool for the reply,

I totally agree with your point that a separate paragraph will be needed if it truly means that all high-risk products should be conducting those studies. However, this still needs to be clarified by the authorities. :yes:

Best regard

Complete thread:

UA Flag
Activity
 Admin contact
23,280 posts in 4,889 threads, 1,655 registered users;
69 visitors (0 registered, 69 guests [including 8 identified bots]).
Forum time: 00:03 CET (Europe/Vienna)

Freedom is always and exclusively
freedom for the one
who thinks differently.    Rosa Luxemburg

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