Bioequivalence and Bioavailability Forum

Dear all,

The French Agency, Afssaps, has started posting a few public assessment reports for approved generic drugs on their web site.

Not much information in the reports, and particularly the 90 % CI and the mean Cmax and AUC are missing. But at least the reports give information on the study design (cross over or parallel groups, single or multiple dose, fasted or fed), the number of subjects, the dose used, the last sampling point and the duration of the wash-out. They also give the country of origin of the reference product (and therefore information that this product is identical, or very similar, to the French product). I don't think the reports should be considered as a guideline or a recommendation, but they could be referred to as something which has been accepted in the past.

The only problem is, the reports are only available in French . But Google Translate is your friend !

Best regards
Ohlbe