Biowaiver criterion <5% (not ≤5%) [Regulatives / Guidelines]

posted by Laura Carreiras – Portugal, 2022-08-12 14:37 (701 d 03:37 ago) – Posting: # 23220
Views: 1,915

Dear Helmut,

Thank you for your quick answer.

Well, I agree with your answer, in fact the guideline is clear. In our case, the value is 5.00%, without rounding. We wanted to know if anyone had already been through this situation and if the competent authorities accepted proportionality.

Thanks again.


Edit: Full quote removed. Please delete everything from the text of the original poster which is not necessary in understanding your answer; see also this post #5[Helmut]

Complete thread:

UA Flag
Activity
 Admin contact
23,099 posts in 4,857 threads, 1,646 registered users;
92 visitors (0 registered, 92 guests [including 12 identified bots]).
Forum time: 18:14 CEST (Europe/Vienna)

Imagine if every Thursday your shoes exploded
if you tied them the usual way.
This happens to us all the time with computers,
and nobody thinks of complaining.    Jef Raskin

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