biological variation, IVIVC [Dissolution / BCS / IVIVC]

posted by satya – 2007-08-17 14:07  – Posting: # 989
Views: 5,737

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?

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