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RegisterFDC or isomers: C0 > 5 % of Cmax [Regulatives / Guidelines]
❝ The ICH’s M13A will soon supersed the FDA’s guidance. However, a similar procedure is stated in its Section 2.2.3.3 Carry over.
❝
❝ The idea of assessing the predose concentrations in higher period(s) is to check whether the washout was sufficiently long. The treatment comparison in the presence of equal/unequal carryover would – unavoidably – be biased and there is no statistical method to adjust for it.
Oh my equal/unequal carryover – never ending story
Complete thread:
- Predose concentration more than 5 % of Cmax NK 2024-08-05 06:07 [Regulatives / Guidelines]
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- FDC or isomers: C0 > 5 % of Cmax Helmut 2024-08-05 08:36
- FDC or isomers: C0 > 5 % of CmaxAchievwin 2024-08-05 19:08
- Carryover. A Never Ending Story. Helmut 2024-08-05 22:39
- Inducers/inhibitors Ohlbe 2024-08-08 18:09
- Inducers/inhibitors Helmut 2024-08-09 08:26
- FDC or isomers: C0 > 5 % of CmaxAchievwin 2024-08-05 19:08
- Predose concentration more than 5 % of Cmax qualityassurance 2024-08-05 12:48
- FDC or isomers: C0 > 5 % of Cmax Helmut 2024-08-05 08:36
Ing. Helmut Schütz