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De-risking Clinical Trials: The BIAL Phase I Trial in Foresight.

作者信息

Cohen Adam F, van Smeden Jeroen, Webb David J

机构信息

DDCD Consulting, Leiden, The Netherlands.

Leiden University Medical Center, Leiden, The Netherlands.

出版信息

Clin Pharmacol Ther. 2022 Feb;111(2):362-365. doi: 10.1002/cpt.2498. Epub 2021 Dec 28.

DOI:10.1002/cpt.2498
PMID:34962650
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC9303912/
Abstract
摘要

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Investigator brochures for phase I/II trials lack information on the robustness of preclinical safety studies.I/II期试验的研究者手册缺乏关于临床前安全性研究稳健性的信息。
Br J Clin Pharmacol. 2021 Jul;87(7):2723-2731. doi: 10.1111/bcp.14615. Epub 2020 Nov 20.
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Strategies and Recommendations for Using a Data-Driven and Risk-Based Approach in the Selection of First-in-Human Starting Dose: An International Consortium for Innovation and Quality in Pharmaceutical Development (IQ) Assessment.采用数据驱动和基于风险的方法选择首次人体起始剂量的策略和建议：国际药物开发创新和质量联盟（IQ）评估。
Clin Pharmacol Ther. 2021 Jun;109(6):1395-1415. doi: 10.1002/cpt.2009. Epub 2020 Nov 3.
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Commentary on the EMA Guideline on strategies to identify and mitigate risks for first-in-human and early clinical trials with investigational medicinal products.欧洲药品管理局关于确定和降低研究用药品首次人体试验和早期临床试验风险策略的指南评注
Br J Clin Pharmacol. 2018 Jul;84(7):1401-1409. doi: 10.1111/bcp.13550. Epub 2018 May 30.
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