Gulf Cooperation Council [Regulatives / Guidelines]

posted by wienui  – Germany/Oman, 2017-03-25 18:40 (2880 d 10:04 ago) – Posting: # 17186
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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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