in vivo ≠ in vitro [Power / Sample Size]

posted by Mithu – India, 2022-07-25 13:26 (19 d 01:39 ago) – Posting: # 23175
Views: 250

» As per regulatory acceptance- it is either acceptable or unacceptable. So is not best to describe it as marginally acceptable.

Just to make it clear that I am trying to say that study is passing at 80.5% lower CI.

» The in vitro assessment with recent batches of reference is important and also performing a comparative dissolution with older lot (if still available) can be useful.
»
» Taking only larger size without consideration of in vitro assessment will not solve your problem.

Thank you.

Regards,

Complete thread:

UA Flag
Activity
 Admin contact
22,301 posts in 4,667 threads, 1,585 registered users;
online 12 (0 registered, 12 guests [including 9 identified bots]).
Forum time: Saturday 15:06 CEST (Europe/Vienna)

In the field of observation,
chance favors only the mind that is prepared.    Louis Pasteur

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