Utility of Model-Based Approaches for Informing Dosing Recommendations in Specific Populations: Report From the Public AAPS Workshop

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• 作者：Islam R. Younis ; J. Robert Powell ; Amin Rostami-Hodjegan ; Brian Corrigan ; Norman Stockbridge ; Vikram Sinha ; Ping Zhao ; Pravin Jadhav ; Bruno Flamion and Jack Cook
• 刊名：The Journal of Clinical Pharmacology
• 出版年：2017
• 出版时间：January 2017
• 年：2017
• 卷：57
• 期：1
• 页码：105-109
• 全文大小：205K
• ISSN：1552-4604

文摘

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.