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

Islam R. Younis; J. Robert Powell; Amin Rostami-Hodjegan; Brian Corrigan; Norman Stockbridge; Vikram Sinha; Ping Zhao; Pravin Jadhav; Bruno Flamion; Jack Cook

doi:10.1002/jcph.787

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

Islam R. Younis, J. Robert Powell, Amin Rostami-Hodjegan, Brian Corrigan, Norman Stockbridge, Vikram Sinha, Ping Zhao, Pravin Jadhav, Bruno Flamion, Jack Cook

URPHYM

Research output: Contribution to journal › Article › peer-review

Abstract

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.

Original language	English
Pages (from-to)	105-109
Number of pages	5
Journal	Journal of Clinical Pharmacology
Volume	57
Issue number	1
DOIs	https://doi.org/10.1002/jcph.787
Publication status	Published - 1 Jan 2017

Keywords

dosing recommendations
modeling and simulation
specific population

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10.1002/jcph.787

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

Abstract

Keywords

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