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Dear Sir
I am a clinical pharmacologist from China, thank you very much for keeping such a wonderful webiste for others, it has been extremely helpful.
I have a question about the subject inclusion in a bioequivalence study:
The Guidance from the EMA says:
"The subject population for bioequivalence studies should be selected with the aim to minimise variability and permit detection of differences between pharmaceutical products."
However the Guidance from the FDA says:
"In general, unless otherwise recommended in a specific guidance:
... In vivo BE study subjects should be representative of the general population,taking into account age, sex, and race... If a drug product is intended for use in both sexes, the applicant should include similar proportions of males and females in the study..."
I wonder if it is ok to maximize the homogeneity of subjects, especially for those highly variable drugs. Because recently a few studies found that genetics play an important role in determining the intra-individual variability.
So we think if we recruit subjects with same genotype, we can have a smaller intra-indivdual variability therefore a smaller sample size.
But we wonder if we are rational (or allowed) to do so.
Thank you very much
I am a clinical pharmacologist from China, thank you very much for keeping such a wonderful webiste for others, it has been extremely helpful.
I have a question about the subject inclusion in a bioequivalence study:
The Guidance from the EMA says:
"The subject population for bioequivalence studies should be selected with the aim to minimise variability and permit detection of differences between pharmaceutical products."
However the Guidance from the FDA says:
"In general, unless otherwise recommended in a specific guidance:
... In vivo BE study subjects should be representative of the general population,taking into account age, sex, and race... If a drug product is intended for use in both sexes, the applicant should include similar proportions of males and females in the study..."
I wonder if it is ok to maximize the homogeneity of subjects, especially for those highly variable drugs. Because recently a few studies found that genetics play an important role in determining the intra-individual variability.
So we think if we recruit subjects with same genotype, we can have a smaller intra-indivdual variability therefore a smaller sample size.
But we wonder if we are rational (or allowed) to do so.
Thank you very much
Complete thread:
- Subject selectionele2008 2014-10-16 05:06
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Genotyping in BE Helmut 2014-10-16 15:04
- Genotyping in BE ele2008 2014-10-16 16:18
- Genotyping in BE nobody 2014-10-16 17:43
- Genotyping in BE Helmut 2014-10-16 18:13
- Genotyping in BE nobody 2014-10-16 18:24
- Any experiences? Helmut 2014-10-17 19:30
- Any experiences? nobody 2014-10-17 20:04
- Any experiences? Helmut 2014-10-18 15:04
- Any experiences? nobody 2014-10-20 08:06
- Any experiences? Helmut 2014-10-20 13:00
- Any experiences? nobody 2014-10-20 14:21
- Any experiences? Helmut 2014-10-20 13:00
- Any experiences? nobody 2014-10-20 08:06
- Any experiences? Helmut 2014-10-18 15:04
- Any experiences? nobody 2014-10-17 20:04
- Any experiences? Helmut 2014-10-17 19:30
- Genotyping in BE nobody 2014-10-16 18:24
- Genotyping in BE Helmut 2014-10-16 18:13
- Genotyping in BE nobody 2014-10-16 17:43
- Genotyping in BE ele2008 2014-10-16 16:18
- Subject selection ele2008 2014-10-23 05:25
- Subject selection ele2008 2014-10-23 16:47
- Subject selection ElMaestro 2014-10-23 17:25
- Subject selection nobody 2014-10-23 17:53
- Editing posts Helmut 2014-10-23 17:54
- ♀ on a mission? Helmut 2014-10-23 19:50
- Subject selection ElMaestro 2014-10-23 17:25
- Subject selection ele2008 2014-10-23 16:47
- Genotyping in BE Helmut 2014-10-16 15:04
Ing. Helmut Schütz