Gulf Cooperation Council [Regulatives / Guidelines]
Hi wienui,
THX for enlightening me! My old PDF-reader did not display the text in the right margin
This one?
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.
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.
❝ […] 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]](img/uploaded/image175.jpg)
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.
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Dif-tor heh smusma 🖖🏼 Довге життя Україна!![[image]](https://static.bebac.at/pics/Blue_and_yellow_ribbon_UA.png)
Helmut Schütz
![[image]](https://static.bebac.at/img/CC by.png)
The quality of responses received is directly proportional to the quality of the question asked. 🚮
Science Quotes
Dif-tor heh smusma 🖖🏼 Довге життя Україна!
![[image]](https://static.bebac.at/pics/Blue_and_yellow_ribbon_UA.png)
Helmut Schütz
![[image]](https://static.bebac.at/img/CC by.png)
The quality of responses received is directly proportional to the quality of the question asked. 🚮
Science Quotes
Complete thread:
- ICH: Strange document Helmut 2013-10-12 22:02 [Regulatives / Guidelines]
- ICH: Strange document wienui 2017-03-25 11:01
- Gulf Cooperation CouncilHelmut 2017-03-25 12:33
- Gulf Cooperation Council wienui 2017-03-25 17:40
- Gulf Cooperation CouncilHelmut 2017-03-25 12:33
- ICH: Strange document wienui 2017-03-25 11:01