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Registerbiological variation, IVIVC [Dissolution / BCS / IVIVC]
Dear Jamie
I am sorry about my ignorance and naivety in this BA/BE area.
Actually my question was not in context of IVIVC but the interindividual variability in response to formulations (pharmacogenomics context!!!!).
Are bioequivalnce studies supposed to be performed in identical population? (ie. same age, sex, race, ethinicity, pathophysiological condition etc)? For known/unknown reasons there may be differences in PK characteristics of formulations in different populations. If so how much variation is allowed to pass the equivalency test?
I am sorry about my ignorance and naivety in this BA/BE area.
Actually my question was not in context of IVIVC but the interindividual variability in response to formulations (pharmacogenomics context!!!!).
Are bioequivalnce studies supposed to be performed in identical population? (ie. same age, sex, race, ethinicity, pathophysiological condition etc)? For known/unknown reasons there may be differences in PK characteristics of formulations in different populations. If so how much variation is allowed to pass the equivalency test?
Complete thread:
- biological variation, IVIVC satya 2007-08-16 22:24
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- biological variation, IVIVC Jaime_R 2007-08-17 13:17
- biological variation, IVIVC satya 2007-08-17 16:07
- BE: study populations Jaime_R 2007-08-17 17:37
- BE: study populations Helmut 2007-11-22 14:44
- BE: study populations Jaime_R 2007-08-17 17:37
- biological variation, IVIVC satya 2007-08-17 16:07
- biological variation, IVIVC Jaime_R 2007-08-17 13:17
Ing. Helmut Schütz