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Consumer's risk in the EMA and FDA regulatory approaches for bioequivalence in highly variable drugs.
Muñoz J, Alcaide D, Ocaña J. Muñoz J, et al. Stat Med. 2016 May 30;35(12):1933-43. doi: 10.1002/sim.6834. Epub 2015 Dec 28. Stat Med. 2016. PMID: 26707698
The 2010 US Food and Drug Administration and European Medicines Agency regulatory approaches to establish bioequivalence in highly variable drugs are both based on linearly scaling the bioequivalence limits, both take a 'scaled ave …
The 2010 US Food and Drug Administration and European Medicines Agency regulatory approaches to establish …
Algorithms for evaluating reference scaled average bioequivalence: power, bias, and consumer risk.
Tothfalusi L, Endrenyi L. Tothfalusi L, et al. Stat Med. 2017 Nov 30;36(27):4378-4390. doi: 10.1002/sim.7440. Epub 2017 Aug 29. Stat Med. 2017. PMID: 28850696
Four algorithms were evaluated in simulated 3-period and 4-period bioequivalence studies: Hyslop's approach recommended by the US FDA, the method of average bioequivalence with expanding limits requested by the European EMA, and 2 version …
Four algorithms were evaluated in simulated 3-period and 4-period bioequivalence studies: Hyslop's approach recommended …