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RegisterFirst Point Cmax (also ICH M13A) [Study Assessment]
Dear Helmut,
Q: Since ICH M13A and FDA requirements are inconsistent, which guidelines need to be followed?
❝ For subjects where Cmax occurs at the first post-dose sampling time, the actual Cmax may have been missed as it could have occurred at an earlier time point. When this occurs, the robustness of the study results in relation to the potential missed Cmax should be discussed. This could include additional analysis where data from the affected subjects are removed from the analysis.
❝ In other words, it is the other way around than for the FDA. Keep the subject(s) in the primary analysis and exclude them in a sensitivity analysis.
Q: Since ICH M13A and FDA requirements are inconsistent, which guidelines need to be followed?
Complete thread:
- First Point Cmax USFDA NK 2024-09-13 06:48 [Study Assessment]
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- First Point Cmax (also ICH M13A) Helmut 2024-09-17 08:38
- First Point Cmax (also ICH M13A)kimhuang 2024-11-27 08:49
- FDA M13A Helmut 2024-11-27 13:50
- First Point Cmax (also ICH M13A)kimhuang 2024-11-27 08:49
- First Point Cmax (also ICH M13A) dshah 2024-11-27 12:50
- First Point Cmax (also ICH M13A) Helmut 2024-09-17 08:38
Ing. Helmut Schütz