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On assessing bioequivalence and interchangeability between generics based on indirect comparisons

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单位: [1]National Clinical Research Center for Digestive Disease, Beijing Friendship Hospital, Capital Medical University, Beijing, China [2]Duke University School of Medicine, 2424 Erwin Road, Hock Plaza, Suite 1102, Durham, NC 27705, U.S.A. [3]Center for Drug Evaluation and Research Organization, Food and Drug Administration, Silver Spring, Maryland, U.S.A.
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关键词: average bioequivalence drug interchangeability generics geometric mean ratio (GMR) indirect comparison

摘要:
As more and more generics become available in the market place, the safety/efficacy concerns may arise as the result of interchangeably use of approved generics. However, bioequivalence assessment for regulatory approval among generics of the innovative drug product is not required. In practice, approved generics are often used interchangeably without any mechanism of safety monitoring. In this article, based on indirect comparisons, we proposed several methods to assessing bioequivalence and interchangeability between generics. The applicability of the methods and the similarity assumptions were discussed, as well as the inappropriateness of directly adopting adjusted indirect comparison to the field of generics' comparison. Besides, some extensions were given to take into consideration the important topics in clinical trials for bioequivalence assessments, for example, multiple comparisons and simultaneously testing bioequivalence among three generics. Extensive simulation studies were conducted to investigate the performances of the proposed methods. The studies of malaria generics and HIV/AIDS generics prequalified by the WHO were used as real examples to demonstrate the use of the methods. Copyright (c) 2017 John Wiley & Sons, Ltd.

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出版当年[2016]版:
大类 | 4 区 医学
小类 | 2 区 统计学与概率论 3 区 数学与计算生物学 3 区 医学:信息 3 区 公共卫生、环境卫生与职业卫生 4 区 医学:研究与实验
最新[2025]版:
大类 | 3 区 数学
小类 | 2 区 数学与计算生物学 3 区 医学:研究与实验 3 区 公共卫生、环境卫生与职业卫生 3 区 统计学与概率论 4 区 医学:信息
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出版当年[2015]版:
Q2 MATHEMATICAL & COMPUTATIONAL BIOLOGY Q2 STATISTICS & PROBABILITY Q3 MEDICINE, RESEARCH & EXPERIMENTAL Q3 PUBLIC, ENVIRONMENTAL & OCCUPATIONAL HEALTH Q3 MEDICAL INFORMATICS
最新[2023]版:
Q1 STATISTICS & PROBABILITY Q3 MATHEMATICAL & COMPUTATIONAL BIOLOGY Q3 MEDICINE, RESEARCH & EXPERIMENTAL Q3 PUBLIC, ENVIRONMENTAL & OCCUPATIONAL HEALTH Q4 MEDICAL INFORMATICS

影响因子: 最新[2023版] 最新五年平均[2021-2025] 出版当年[2015版] 出版当年五年平均[2011-2015] 出版前一年[2014版] 出版后一年[2016版]

第一作者:
第一作者单位: [1]National Clinical Research Center for Digestive Disease, Beijing Friendship Hospital, Capital Medical University, Beijing, China [2]Duke University School of Medicine, 2424 Erwin Road, Hock Plaza, Suite 1102, Durham, NC 27705, U.S.A. [*1]Duke University School of Medicine, 2424 Erwin Road, Hock Plaza, Suite 1102, Durham, NC 27705, U.S.A.
通讯作者:
通讯机构: [1]National Clinical Research Center for Digestive Disease, Beijing Friendship Hospital, Capital Medical University, Beijing, China [2]Duke University School of Medicine, 2424 Erwin Road, Hock Plaza, Suite 1102, Durham, NC 27705, U.S.A. [*1]Duke University School of Medicine, 2424 Erwin Road, Hock Plaza, Suite 1102, Durham, NC 27705, U.S.A.
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