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

posted by jag009  – NJ, 2022-09-02 02:29 (93 d 11:20 ago) – Posting: # 23260
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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..


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