title: Utility of Model-Based Approaches for Informing Dosing Recommendations in Specific Populations: Report From the Public AAPS Workshop.
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.
authors.affiliation: Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA.
authors.forename: Islam R
authors.initials: IR
authors.lastname: Younis
authors.affiliation: Independent Consultant, Chapel Hill, NC, USA.
authors.forename: J
authors.initials: J
authors.lastname: Robert Powell
authors.affiliation: Systems Pharmacology, University of Manchester, Manchester, UK.
authors.forename: Amin
authors.initials: A
authors.lastname: Rostami-Hodjegan
authors.affiliation: Clinical Pharmacology, Pfizer Inc, Groton, CT, USA.
authors.forename: Brian
authors.initials: B
authors.lastname: Corrigan
authors.affiliation: Office of New Drugs, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA.
authors.forename: Norman
authors.initials: N
authors.lastname: Stockbridge
authors.affiliation: Quantitative Pharmacology and Pharmacometrics, Merck and Co, North Wales, PA, USA.
authors.forename: Vikram
authors.initials: V
authors.lastname: Sinha
authors.affiliation: Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA.
authors.forename: Ping
authors.initials: P
authors.lastname: Zhao
authors.affiliation: Innovative Data Solutions, Otsuka Pharmaceutical Companies, Princeton, NJ, USA.
authors.forename: Pravin
authors.initials: P
authors.lastname: Jadhav
authors.affiliation: Department of Medicine, University of Namur, Namur, Belgium.|Past Chair of Scientific Advice Working Party, European Medicines Agency, London, UK.
authors.forename: Bruno
authors.initials: B
authors.lastname: Flamion
authors.affiliation: Clinical Pharmacology, Pfizer Inc, Groton, CT, USA.
authors.forename: Jack
authors.initials: J
authors.lastname: Cook
mesh_terms: D035843:Biomedical Research / Q000379:methods* / Q000639:trends; D004345:Drug Industry / Q000379:methods* / Q000639:trends; D004493:Education / Q000379:methods* / Q000639:trends; D005431:Florida; D006801:Humans; D008954:Models, Biological; D004364:Pharmaceutical Preparations / Q000008:administration & dosage* / Q000378:metabolism; D058028:Research Report / Q000639:trends
chemical_list: D004364:Pharmaceutical Preparations
keywords: dosing recommendations; modeling and simulation; specific population