基于模型的方法在为特定人群提供给药建议中的应用：美国药学协会公共研讨会报告
Utility of Model-Based Approaches for Informing Dosing Recommendations in Specific Populations: Report From the Public AAPS Workshop.
作者信息
Younis Islam R, Robert Powell J, Rostami-Hodjegan Amin, Corrigan Brian, Stockbridge Norman, Sinha Vikram, Zhao Ping, Jadhav Pravin, Flamion Bruno, Cook Jack
机构信息
Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA.
Independent Consultant, Chapel Hill, NC, USA.
出版信息
J Clin Pharmacol. 2017 Jan;57(1):105-109. doi: 10.1002/jcph.787. Epub 2016 Sep 5.
This report summarizes the discussions and recommendations of the workshop titled "Specific Population Drug Dosing Recommendations: Shifting from Clinical Studies to Predict and Confirm," which preceded the 2015 American Association of Pharmaceutical Scientists annual meeting. Participants from the pharmaceutical industry, regulatory agencies (FDA and EMA), and academia discussed the current state, challenges, opportunities, and future direction of utilizing model-based approaches to inform dosing recommendations in specific populations.
本报告总结了在2015年美国药物科学家协会年会之前举办的题为“特定人群给药剂量建议：从临床研究转向预测与确认”研讨会的讨论内容及建议。来自制药行业、监管机构（美国食品药品监督管理局和欧洲药品管理局）以及学术界的与会者讨论了利用基于模型的方法为特定人群给药剂量建议提供信息的现状、挑战、机遇和未来方向。
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