US (or EU) ANDA: Fail f2 but pass BE? [Regulatives / Guidelines]

posted by jag009  – NJ, 2022-09-02 02:29 (969 d 08:57 ago) – Posting: # 23260
Views: 4,911

Thanks Osama.

That's my thinking as well since the BE studies were ~ 100% in ratios and reasonably sized.
But explaining to those non-pk/bioparm management f**ls who keep asking for risk assessment BS is a challenge.

❝ What about if you start with sampling time points @ 10 min ( EMA) and not @ 5min ( FDA)?

❝ have you tried with bootstrapping to overcome the high variability in the early sampling time points?


Unfortunately the guidance asked for 5 and 10 mins and on... evaluating the data now to see if there is need to evaluate..

john

Complete thread:

UA Flag
Activity
 Admin contact
23,424 posts in 4,927 threads, 1,670 registered users;
77 visitors (0 registered, 77 guests [including 3 identified bots]).
Forum time: 11:27 CEST (Europe/Vienna)

There are two possible outcomes: if the result confirms the
hypothesis, then you’ve made a measurement. If the result is
contrary to the hypothesis, then you’ve made a discovery.    Enrico Fermi

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