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Registerin vivo ≠ in vitro [Power / Sample Size]
» 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,
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:
- BCS Class II & IV molecule Mithu 2022-07-25 06:39 [Power / Sample Size]
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- BCS Class II & IV molecule dshah 2022-07-25 09:44
- BCS Class II & IV molecule Mithu 2022-07-25 10:56
- in vivo ≠ in vitro Helmut 2022-07-25 09:56
- in vivo ≠ in vitro Mithu 2022-07-25 10:54
- in vivo ≠ in vitro dshah 2022-07-25 11:19
- in vivo ≠ in vitroMithu 2022-07-25 13:26
- Assumptions Helmut 2022-07-25 13:02
- Assumptions Mithu 2022-07-25 13:24
- in vivo ≠ in vitro dshah 2022-07-25 11:19
- in vivo ≠ in vitro Mithu 2022-07-25 10:54
- BCS Class II & IV molecule dshah 2022-07-25 09:44
Ing. Helmut Schütz