A Bioequivalence Approach for Generic Narrow Therapeutic Index Drugs: Evaluation of the Reference-Scaled Approach and Variability Comparison Criterion

Various health communities have expressed concerns regarding whether average bioequivalence (BE) limits (80.00–125.00%) for the 90% confidence interval of the test-to-reference geometric mean ratio are sufficient to ensure therapeutic equivalence between a generic narrow therapeutic index (NTI) drug...

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Vydáno v:AAPS J
Hlavní autoři: Jiang, Wenlei, Makhlouf, Fairouz, Schuirmann, Donald J., Zhang, Xinyuan, Zheng, Nan, Conner, Dale, Yu, Lawrence X., Lionberger, Robert
Médium: Artigo
Jazyk:Inglês
Vydáno: Springer US 2015
Témata:
Research Article
On-line přístup:https://ncbi.nlm.nih.gov/pmc/articles/PMC4476992/
https://ncbi.nlm.nih.gov/pubmed/25840883
https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1208/s12248-015-9753-5
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