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Registerin vivo ≠ in vitro [Power / Sample Size]
Hi Mithu!
As per regulatory acceptance- it is either acceptable or unacceptable. So is not best to describe it as marginally acceptable.
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.
Regards,
Divyen Shah
❝ Here the case is, we are dealing with some technology transfer products in which we could not change our test formulation which was meet the BE marginally at the time of initially filing. now due to this bottle neck, our thinking is if we take little large sample size, than we can manage variability (my expectation may be not correct).
As per regulatory acceptance- it is either acceptable or unacceptable. So is not best to describe it as marginally acceptable.
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.
Regards,
Divyen Shah
Complete thread:
- BCS Class II & IV molecule Mithu 2022-07-25 06:39
![[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 vitrodshah 2022-07-25 11:19
- in vivo ≠ in vitro Mithu 2022-07-25 13:26
- Assumptions Helmut 2022-07-25 13:02
- Assumptions Mithu 2022-07-25 13:24
- in vivo ≠ in vitrodshah 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