Bioequivalence and Bioavailability Forum

Dear HS,

❝ HPB hopes '... to be able to present our findings at the next Canadian

❝ Workshop on Recent Issues in GLP Bioanalysis on April 17-18, 2008 in

❝ Montreal.'

HPB are indeed the ones who have the more information available on incurred sample re-analysis ! Even though what they received in the past was probably biased as the data showing the more problems were probably never submitted.

It is great to see that other authorities are also trying to make their own minds on this topic, not just following FDA or doing nothing at all. I hope some movement will start in Europe one day too. European industry have started to think about it through the European Bioanalysis Forum, but so far it seems they are only opened to pharma companies, not CROs, and I don't know if they have established contacts with European regulatory bodies.

From what I have heard of the recent AAPS meeting, FDA was again very strict and not open to discussions. It seems that they would require incurred sample reanalysis for each BE trial, not just once for all trials at the same site with the same method. I can understand requiring it for patients and special populations in addition to healthy volunteers, but why it should be done for each and every BE study, all on healthy subjects, remains unclear to me.

Regards
Ohlbe