Bioequivalence and Bioavailability Forum

Hi Helmut,

after browsing through the document, I'm a little bit confused...

Are the rumors of a nostalgic 'Habsburgian' conspiracy with some Hungarian/Spanish/Dutch touch true?

What makes me wonder is the fact that it took nine drafted versions to proceed from one adopted NfG on BA/BE (1992) to the last one (2001): endless discussions, presentations at international conferences, etc.

The MR-NfG obviously remains 'stuck' at Draft #15 from 1999, and now we have a Q&A document which was (secretly?) prepared by an anonymous 'Therapeutic Subgroup on Pharmacokinetics (EWP-PK)': no drafted versions, no public discussion, etc.

I'm asking myself whether the EWP-PK (with its eight members, again according to rumors...) is representative of the European Regulatority Authorities?

But possibly preparing such a document is just a displacement activity for the real important stuff: two separate guidances for BA and BE!