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RegisterEMA vs. FDA [PK / PD]
Dear Ram,
Yes. The FDA guideline recommends that both AUCt and AUCinf be used to measure total exposure. No chance to put AUCinf aside for FDA submissions (at least according to the guideline).
The current EMA guideline considers AUCt to be "the most reliable reflection of the extent of absorption".
Regards
Ohlbe
❝ For Europe, we are conducting the study...
❝ is this can change your answer?
Yes. The FDA guideline recommends that both AUCt and AUCinf be used to measure total exposure. No chance to put AUCinf aside for FDA submissions (at least according to the guideline).
The current EMA guideline considers AUCt to be "the most reliable reflection of the extent of absorption".
Regards
Ohlbe
Complete thread:
- AUC infinity kram 2010-01-13 11:06 [PK / PD]
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- AUC infinity Ohlbe 2010-01-13 11:35
- AUC infinity kram 2010-01-13 13:15
- EMA vs. FDAOhlbe 2010-01-13 17:36
- AUC infinity kram 2010-01-13 13:15
- A posteriori power Helmut 2010-01-13 14:23
- AUC infinity Ohlbe 2010-01-13 11:35
Ing. Helmut Schütz