| 开发评审新药的药物动力学进展 |
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| 引用本文： | 曾衍霖.开发评审新药的药物动力学进展[J].中国医药工业杂志,1994,25(12):560-563. |
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| 作者姓名： | 曾衍霖 |
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| 作者单位： | 中国科学院上海药物研究所 |
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| 摘 要： | 综述了有关新药开发的审评中临床药理学的新进展，包括：１．创新药：阶段性流水作业法，新药开发各阶段的药物动力学研究，药物流行病学研究，毒物动力学；２．仿制药：实验设计与受试人数，药物动力学参数，统计分析，指导原则的国际协调。
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| 关 键 词： | 新药开发，新药审评，进展 |
RECENT PROGRESS OF PHARMACOKINETICS IN NEW DRUG DEVELOPMENT |
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| Authors: | ZENG Yan-Lin |
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| Abstract: | Recent progress of pharmacokinetics in the new drug development and evaluation was reviewed, concerning 1. new chemical entities: the phased approach; pharmacokinetic studies in the various stapes of clinical studies; the pharmacoepidemiologic studies; the toxicokinetic studies; 2. generic drugs: the experimental design and sample size; the pharmacokinetic parameters; the statistical analysis. |
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| Keywords: | new drug development regulatory affairs progress |
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