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关键词
BA1 ()BA2 ()BA21 ()BA21C ()BEBioequivalenceCICVwConditional probabilityGMRGenericsNNTINarrow therapeutic index drugsPharmacokinetic simulationsRSwitchabilityTT(1)T(2)acceptance limit of bioequivalence imposed by the regulatory authoritiesbioequivalencecoefficient of variation of the within-subject variabilityconfidence intervalgeneric assessed after the approval of the first genericgeneric first approvedgeometric mean ratio of the bioequivalence metric for the two products (T over R)narrow therapeutic index drugpercent bioequivalence acceptance of generic T(1) when compared to the reference productpercent bioequivalence acceptance of generic T(2) when compared to the reference productpercent bioequivalence acceptance of generic T(2)versus another generic T(1)percent bioequivalence acceptance of generic T(2)versus another generic T(1) given that both T(1) and T(2) are declared bioequivalent to the same reference formulationreference productsample sizetest product (generic)θ
主题词
计算机模拟(Computer Simulation);剂量效应关系, 药物(Dose-Response Relationship, Drug);药物, 通用名(Drugs, Generic);人类(Humans);蒙特卡罗法(Monte Carlo Method);治疗等效(Therapeutic Equivalency)
DOI
10.1016/j.ejps.2013.08.023
PMID
23981332
发布时间
2013-10-04
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