in vivo ≠ in vitro [Power / Sample Size]

posted by Mithu – India, 2022-07-25 15:26 (631 d 12:24 ago) – Posting: # 23175
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❝ 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,

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