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Register> 5% of Cmax for endogenous molecule? [Regulatives / Guidelines]
Dear All,
As per guidelines, Subjects with non-zero baseline concentrations > 5% of Cmax. Such data should be excluded from bioequivalence calculation.
Is it applicable for endogenous molecule? could you please suggest anyone..
Regards,
Ramesh. R
As per guidelines, Subjects with non-zero baseline concentrations > 5% of Cmax. Such data should be excluded from bioequivalence calculation.
Is it applicable for endogenous molecule? could you please suggest anyone..
Regards,
Ramesh. R
Complete thread:
- > 5% of Cmax for endogenous molecule?Ramesh Ramalingam 2018-06-18 08:00 [Regulatives / Guidelines]
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Any own thoughts? Helmut 2018-06-18 10:59
- carryover effect in endogenous substances Ramesh Ramalingam 2018-08-08 07:29
- Any own thoughts? Helmut 2018-06-18 10:59
Ing. Helmut Schütz