Bioequivalence and Bioavailability Forum

Hi wienui,

❝ […] this is the GCC Guideline on drug BE Requirements.

THX for enlightening me! My old PDF-reader did not display the text in the right margin

GuideLines OnDrug Bioequivalence Requirements In The GCC Countries

❝ More stranger is the actual one from 2016

This one?
Not that bad. Testing for the sequence-effect (unequal carry-over) dropped; AUC_0–72 for IR formulations, BCS-based biowaivers, and Two-Stage Designs added. Bioanalytics according to the EMA’s GL. Interesting: No reference-scaling for HVD(P)s but prospective widening of the acceptance range for C_max to 75–133% if CV_wR >30% shown in a replicate design (according to the EMA’s obsolete Q&A-document of 2006).

BTW, I like the addresses on pp. 46 of the 2006 GL. The list contains my old CRO, which in 2006 was out of business.
Instead of Wien it states Wein.
Although wine is cultivated on 628 hectares in Vienna (and the Heuriger is very popular) I’m not aware of a single Vitis vinifera in our backyard; we had only Parthenocissus tricuspidata. Nesting blackbirds prove that it was a calm place – no screaming volunteers running around. This was my office’s window. The ceaseless chirping of the nestlings was a pain in the neck. I was happy once they made their “maiden flight” after two weeks.