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

Research output: Contribution to journalArticlepeer-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 languageEnglish
Pages (from-to)105-109
Number of pages5
JournalJournal of Clinical Pharmacology
Volume57
Issue number1
DOIs
Publication statusPublished - 1 Jan 2017

Keywords

  • dosing recommendations
  • modeling and simulation
  • specific population

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