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RegisterBE assessment regarding first time point Cmax [Study Assessment]
Dear Mann,
I've found the following on page 298 of "Generic Drug Product Development - Solid Oral Dosage Forms" by Leon Shargel & Isadore Kanfer":
First point Cmax: Do any of the concentrations vs. time profiles exhibit first-point Cmax (i.e., the first sample collected is the Cmax value)?
If so, were 3 to 5 samples collected within the first hour and was one of these collected between 5 and 15 minutes post-dose?
If these early samples were collected, no change in data analysis is warranted.
If these early samples were not collected, then those subjects with first point Cmax values should be dropped from the primary statistical analysis.
I couldn't find the reference from EMA or FDA about dropping the subjects. I've contacted to Dr. Leon Shargel via e-mail and asked him the same question.
I will post here, as soon as he replied me.
Regards,
Erkin
I've found the following on page 298 of "Generic Drug Product Development - Solid Oral Dosage Forms" by Leon Shargel & Isadore Kanfer":
First point Cmax: Do any of the concentrations vs. time profiles exhibit first-point Cmax (i.e., the first sample collected is the Cmax value)?
If so, were 3 to 5 samples collected within the first hour and was one of these collected between 5 and 15 minutes post-dose?
If these early samples were collected, no change in data analysis is warranted.
If these early samples were not collected, then those subjects with first point Cmax values should be dropped from the primary statistical analysis.
I couldn't find the reference from EMA or FDA about dropping the subjects. I've contacted to Dr. Leon Shargel via e-mail and asked him the same question.
I will post here, as soon as he replied me.
Regards,
Erkin
Complete thread:
- BE assessment regarding first time point Cmax Mann 2018-12-09 10:14 [Study Assessment]
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- BE assessment regarding first time point Cmax Ohlbe 2018-12-09 23:46
- BE assessment regarding first time point Cmax Mann 2018-12-10 00:28
- BE assessment regarding first time point Cmax Ohlbe 2018-12-11 00:05
- FDA and outliers mittyri 2018-12-11 16:38
- BE assessment regarding first time point CmaxErkin 2018-12-28 08:29
- BE assessment regarding first time point Cmax ElMaestro 2018-12-28 14:32
- BE assessment regarding first time point Cmax Erkin 2018-12-28 20:57
- regulatory reasons to consider the study inadequate Astea 2019-03-02 18:02
- Good question, next question Helmut 2019-03-03 19:42
- first point Cmax: trouble waiting to happen? Astea 2019-03-03 21:42
- Good question, next question Helmut 2019-03-03 19:42
- regulatory reasons to consider the study inadequate Astea 2019-03-02 18:02
- BE assessment regarding first time point Cmax Erkin 2018-12-28 20:57
- BE assessment regarding first time point Cmax ElMaestro 2018-12-28 14:32
- BE assessment regarding first time point Cmax Mann 2018-12-10 00:28
- BE assessment regarding first time point Cmax Ohlbe 2018-12-09 23:46
Ing. Helmut Schütz