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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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Gorde:
Xehetasun bibliografikoak
Argitaratua izan da:AAPS J
Egile Nagusiak: Tothfalusi, Laszlo, Endrenyi, Laszlo
Formatua: Artigo
Hizkuntza:Inglês
Argitaratua: Springer US 2016
Gaiak:
Sarrera elektronikoa: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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