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Hi Helmut,
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.
Yes, This is really also very interesting.
All the best,
❝ 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
Cheers,
Osama
Complete thread:
- ICH: Strange document Helmut 2013-10-12 22:02 [Regulatives / Guidelines]
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- ICH: Strange document wienui 2017-03-25 11:01
- Gulf Cooperation Council Helmut 2017-03-25 12:33
- Gulf Cooperation Councilwienui 2017-03-25 17:40
- Gulf Cooperation Council Helmut 2017-03-25 12:33
- ICH: Strange document wienui 2017-03-25 11:01
Ing. Helmut Schütz