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An Exact Procedure for the Evaluation of Reference-Scaled Average Bioequivalence

Reference-scaled average bioequivalence (RSABE) has been recommended by Food and Drug Administration (FDA), and in its closely related form by European Medicines Agency (EMA), for the determination of bioequivalence (BE) of highly variable (HV) and narrow therapeutic index (NTI) drug products. FDA s...

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Foilsithe in:AAPS J
Main Authors: Tothfalusi, Laszlo, Endrenyi, Laszlo
Formáid: Artigo
Teanga:Inglês
Foilsithe: Springer US 2016
Ábhair:
Rochtain Ar Líne:https://ncbi.nlm.nih.gov/pmc/articles/PMC4779113/
https://ncbi.nlm.nih.gov/pubmed/26831249
https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1208/s12248-016-9873-6
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