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

J Clin Pharmacol. 2017 Jan;57(1):105-109. doi: 10.1002/jcph.787. Epub 2016 Sep 5.

Authors

Affiliations

¹ Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA.
² Independent Consultant, Chapel Hill, NC, USA.
³ Systems Pharmacology, University of Manchester, Manchester, UK.
⁴ Clinical Pharmacology, Pfizer Inc, Groton, CT, USA.
⁵ Office of New Drugs, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA.
⁶ Quantitative Pharmacology and Pharmacometrics, Merck and Co, North Wales, PA, USA.
⁷ Innovative Data Solutions, Otsuka Pharmaceutical Companies, Princeton, NJ, USA.
⁸ Department of Medicine, University of Namur, Namur, Belgium.
⁹ Past Chair of Scientific Advice Working Party, European Medicines Agency, London, UK.

PMID: 27365151
DOI: 10.1002/jcph.787

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.

Keywords: dosing recommendations; modeling and simulation; specific population.

MeSH terms

Biomedical Research / methods*
Biomedical Research / trends
Drug Industry / methods*
Drug Industry / trends
Education / methods*
Education / trends
Florida
Humans
Models, Biological*
Pharmaceutical Preparations / administration & dosage*
Pharmaceutical Preparations / metabolism
Research Report* / trends

Substances

Pharmaceutical Preparations