HVDs/HVDPs = safe drugs [Off Topic]

posted by varun9461 – India, 2019-02-22 12:23 (606 d 19:32 ago) – Posting: # 19966
Views: 3,203

» Coming back to clopidogrel: Its high variability is mainly caused by both presystemic and first-pass meta­bolism. The EMA in its Q&A-document do not recommend reference-scaling based on unclear clinical implications. Don’t know what USFDA’s current thinking is. The product-specific guidance is quite old (08/2008) and was issued before RSABE first appeared as an option (04/2010). The FDA generally does not require a clinical justification (contrary to the EMA) and allows scaling for both AUC and Cmax.

Question: wrt to EMA Q&A about clopidogrel not allowing widening on CMAX, can we plan full replicate BE study with BE Limit of 80.00-125.00% or two way cross over BE study needs to be performed?

Edit: Full quote removed. Please delete everything from the text of the original poster which is not necessary in understanding your answer (see also this post #5). Standard quotes restored (see in the same post #8). Please follow the Forum’s Policy[Helmut]

Complete thread:

 Admin contact
21,170 posts in 4,411 threads, 1,474 registered users;
online 5 (0 registered, 5 guests [including 3 identified bots]).
Forum time: Wednesday 08:55 CEST (Europe/Vienna)

But it is in matters beyond the limits of mere rule
that the skill of the analyst is evinced.
He makes in silence a host of observations and inferences…    Edgar Allan Poe

The Bioequivalence and Bioavailability Forum is hosted by
BEBAC Ing. Helmut Schütz