FDA: antique of ’93 [Regulatives / Guidelines]

posted by Beholder  – Russia, 2018-06-21 09:21 (1224 d 20:46 ago) – Posting: # 18936
Views: 7,029

Hi Helmut and all!

» Now I know where the Europeans copypasted from.

I went through the forum but still could not find the information. Ok, we know that it is "highly likely" (;-)) that the EMA took "1/10 or 100,000 rule" from FDA. But why did FDA deside to use 1/10 or 100,000 rule? Why not, for instance, "1/15 and 150,000" or 100,000 is just round number and that's all?

Thank you in advance

Best regards
Beholder

Complete thread:

Activity
 Admin contact
21,760 posts in 4,550 threads, 1,545 registered users;
online 14 (0 registered, 14 guests [including 2 identified bots]).
Forum time: Thursday 06:08 CEST (Europe/Vienna)

Always remember that you are absolutely unique.
Just like everyone else.    Margaret Mead

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