Helmut
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Vienna, Austria,
2013-10-13 00:02
(3819 d 15:30 ago)

Posting: # 11654
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 ICH: Strange document [Regulatives / Guidelines]

Hi all,

I found a strange document on ICH’s site. Dated 20 December 2006. Sounds Arabic. Does someone know / is willing to share its background?

Dif-tor heh smusma 🖖🏼 Довге життя Україна! [image]
Helmut Schütz
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wienui
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Germany/Oman,
2017-03-25 12:01
(2560 d 02:30 ago)

(edited by wienui on 2017-03-25 17:53)
@ Helmut
Posting: # 17184
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 ICH: Strange document

❝ I found a strange document on ICH’s site. Dated 20 December 2006. Sounds Arabic. Does someone know / is willing to share its background?


Hi Helmut,
You are right this is the GCC Guideline on drug BE Requirements. More stranger is the actual one from 2016, it is like what the german say (Blumen von jedem Garden), total oberflächlich!!!!
All the best,

Cheers,
Osama
Helmut
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Vienna, Austria,
2017-03-25 13:33
(2560 d 00:58 ago)

@ wienui
Posting: # 17185
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 Gulf Cooperation Council

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
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wienui
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Germany/Oman,
2017-03-25 18:40
(2559 d 19:51 ago)

@ Helmut
Posting: # 17186
Views: 2,406
 

 Gulf Cooperation Council

Hi Helmut,

❝ 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.


What is then considered to be bad for you Helmut!, I give you only one example, although the BCS Biowaivers paragraph is totally just quoted from the EMA GL, but according to the GCC GL in contrast to EMA, WHO and FDA (May 2015) state clear in P.34, 35 and 39 Biowaiving of high soluble drugs are allowed, but gave an example only for (BCS Class I) and didn't mentioned clear at all to Class III, as if BCS class III is not for highly soluble drugs.

❝ 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).


Yes, This is really also very interesting.

All the best,

Cheers,
Osama
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