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RegisterHVDs/HVDPs = safe drugs [Off Topic]
» 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]
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:
- effectiveness of highly variable drugs Ken Peh 2013-12-17 03:45 [Off Topic]
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- HVDs/HVDPs = safe drugs Helmut 2013-12-17 15:11
- HVDs/HVDPs = safe drugsvarun9461 2019-02-22 12:23
- effectiveness of highly variable drugs Dr_Dan 2013-12-18 09:34
- effectiveness of highly variable drugs Ohlbe 2013-12-18 10:07
- effectiveness of highly variable drugs Ken Peh 2013-12-20 14:38
- Period effect kumarnaidu 2014-01-28 07:54
- Period effect Dr_Dan 2014-01-28 10:36
- Period effect kumarnaidu 2014-01-28 11:51
- Period effect Helmut 2014-01-28 13:48
- Period effect kumarnaidu 2014-01-29 04:49
- Period effect Helmut 2014-01-28 13:48
- Period effect kumarnaidu 2014-01-28 11:51
- Period effect Dr_Dan 2014-01-28 10:36
- Period effect kumarnaidu 2014-01-28 07:54
- effectiveness of highly variable drugs Ken Peh 2013-12-20 14:38
- effectiveness of highly variable drugs Ohlbe 2013-12-18 10:07
- HVDs/HVDPs = safe drugs Helmut 2013-12-17 15:11
Ing. Helmut Schütz