关于DDI,FDA和中国药监局都有相应的指导原则,供参考 ICH: M12 Drug Interaction Studies (2022) FDA: In Vitro Drug Interaction Studies – Cytochrome P450 Enzyme- and Transporter-Mediated Drug Interactions Guidance for Industry (2020) FDA: Clinical Drug Interaction Studies – Cytochrome P450 Enzyme- and ...
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/vitro-drug-interaction-studies-cytochrome-p450-enzyme-and-transporter-mediated-drug-interactions [2] 药物相互作用研究技术指导原则(试行)(NMPA 2021年1月) http://www.cde.org.cn/news.do?method=viewInfoCommon&id=cc85bdbe69af7f7...
如果研究表明寡核苷酸药物可以调节CYP酶或转运体,申办方应考虑在临床试验中评估体内药物相互作用。对于研究设计和实施的一般注意事项,请参阅FDA《Clinical Drug Interaction Studies — Cytochrome P450 Enzyme- and Transporter-Mediated Drug Interactions Guidanc...
如果研究表明寡核苷酸药物可以调节CYP酶或转运体,申办方应考虑在临床试验中评估体内药物相互作用。对于研究设计和实施的一般注意事项,请参阅FDA《Clinical Drug Interaction Studies — Cytochrome P450 Enzyme- and Transporter-Mediated Drug Interactions Guidance for Industry (January 2020)》。 2.药效学相互作用 当一...
如果研究表明寡核苷酸药物可以调节CYP酶或转运体,申办方应考虑在临床试验中评估体内药物相互作用。对于研究设计和实施的一般注意事项,请参阅FDA《Clinical Drug Interaction Studies — Cytochrome P450 Enzyme- and Transporter-Mediated Drug Interactions Guidance for Industry (January 2020)》。
M12 DRUG INTERACTION STUDIES This draft guidance, when finalized, will represent the current thinking of the Food and Drug Administration (FDA or Agency) on this topic. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approa...
FDA: Drug-Drug Interaction Assessment for Therapeutic Proteins Guidance for Industry (2023) NMPA:《药物相互作用研究技术指导原则(试行)》(2021) DDI哪家强(按字母顺序排列) 1. 关于爱思益普 北京爱思益普生物科技股份有限公司的 DMPK 平台提供从早期药物筛选成药性分析、临床前开发等阶段的综合型药代动力学服务...
Besides in vitro experiments, in silico modeling and simulation may also assist in the prediction of drug interactions. The recent FDA draft drug interaction guidance highlighted the in vitro models and criteria that may be used to guide further in vivo drug interaction studies and to construct ...
内容提示: Clinical Drug Interaction Studies — Cytochrome P450 Enzyme- and Transporter-Mediated Drug Interactions Guidance for Industry U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) January 2020 Clinical Pharmacology 文档格式:...
ICH M12 Drug-Drug Interaction Studies Final Guidance, October 9, 2024 (Hosted by CDER SBIA)美东时间2024年10月9日，FDA CDER举行了题为“ ICH M12 药物相互作用研究最终指南”的研讨会。该网络研讨会将讨论ICH M12药物相互作用研究指南，该指南是第一份全球统一的监管指南，用于评估由代谢酶和药物转运体介导...