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| 人体生物等效性研究中受试者的选择和安全性考虑 | |
| 引用本文： | 曹彦硕, 陈学愚. 人体生物等效性研究中受试者的选择和安全性考虑[J]. 药学进展, 2018, 42(9): 668-674. |
| 作者姓名： | 曹彦硕 陈学愚 |
| 作者单位： | 1.北京大学肿瘤医院暨北京市肿瘤防治研究所消化肿瘤内科，恶性肿瘤发病机制及转化研究教育部重点实验室，北京 100142;2.玛格丽特公主癌症中心，安大略省 多伦多M5G 2M9 |
| 摘 要： | 人体生物等效性研究是仿制药研发中的一个重要环节。虽然这些药物本身有较完整的安全性数据和较长的临床应用经验，它们会因为自身的药理作用，可能在健康受试者身上引起副作用。讨论了健康受试者的选择标准、在人体生物等效性研究中可能出现的副作用和相应的预防策略，以及临床检验中异常值的处理方法。 |
| 关 键 词： | 仿制药 生物等效性 健康受试者 安全性 |
Pooled bioequivalence study database from Turkey: characterization of adverse events and determination of split points based on Gini index as a promising method |
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| CAO Yanshuo, CHEN Xueyu. Subject Selection and Safety Considerations in Human Bioequivalence Study[J]. Progress in Pharmaceutical Sciences, 2018, 42(9): 668-674. | |
| Authors: | CAO Yanshuo CHEN Xueyu |
| Affiliation: | 1.Key Laboratory of Carcinogenesis and Translational Research, Gastrointestinal Oncology Department, Peking University Cancer Hospital & Institute, Beijing 100142, China;2.Princess Margaret Cancer Centre, Toronto M5G 2M9, Canada |
| Abstract: | Human bioequivalence study is an essential step in the development of generic formulations. Although these drugs have comprehensive safety profiles and well-established clinical application, they may cause adverse effects in healthy volunteers due to their expected pharmacologic effects. The criteria of selecting healthy volunteers, potential adverse effects in human bioequivalence study and corresponding precautions, as well as the processing of abnormal values in clinical trial were reviewed in this article. |
| Keywords: | generic drug bioequivalence healthy volunteer safety |
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