HVDs/HVDPs = safe drugs [Off Topic]

posted by varun9461 – India, 2019-02-22 12:23  – Posting: # 19966
Views: 2,032

» 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]

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