Gulf Cooperation Council [Regulatives / Guidelines]

posted by Helmut Homepage – Vienna, Austria, 2017-03-25 13:33 (2875 d 20:02 ago) – Posting: # 17185
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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?
[image]Not that bad. Testing for the sequence-effect (unequal carry-over) dropped; AUC0–72 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 Cmax to 75–133% if CVwR >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. :party:
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.

Dif-tor heh smusma 🖖🏼 Довге життя Україна! [image]
Helmut Schütz
[image]

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