Inclusion criteria in BE studies [Design Issues]

posted by ElMaestro  – Denmark, 2020-05-25 14:39 (519 d 18:08 ago) – Posting: # 21463
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I agree with everything.
Just wish to mention that Gender is a between-subject factor (at least for most practical purposes ex-Thailand), so there is no particular gain in including Gender as a factor when you have Subject in the model unless there is a specific regulatory requirement.

While PK may be different between Genders, like it would be between old and young subjects, or smokers and non-smokers, African-Americans versus Eskimos etc. But in BE we are interested in the ratio of T/R and this ratio has never in any particularly good study proven to vary between sub-populations. Hence the relaxed attitude towards e.g. studies done in e.g. India for approval in US and so forth.
[Crystal ball] When the day comes, when someone is able to prove a case of real and true population difference in BE conclusion between populations, then BE as we know it today might be history and the innovator industry will jump on it like you would not believe possible with lawsuits left and right to protect their brands.[/Crystal ball]

Pass or fail!

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