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Drug Information Association, University of California, Washington Center, Washington, DC, USA
May 6 2008
Data from trials and practice show that ambulatory patients frequently underdose, either by: never starting dosing, omitting scheduled doses, or premature cessation of dosing. Routine methods fail to detect most of these errors. Yet variable dosing histories are a major source of variance in drug response, confounding the interpretation of all dose/time-dependent trial outcomes, eg, estimates of PK parameters, dose-dependent efficacy, regimen definition, dose-dependent toxicity. Properly analyzed dosing histories can improve learning-phase trials. FEATURED TOPICS·Documenting and managing adherence in clinical trials·Methods of compiling and assessing drug dosing histories·Adherence-informed pharmacometric analysis of effectiveness·Safety·Dosage-regimen optimization·Regulatory issues·Labeling·Statistical considerations.
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Organized by:
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Drug Information Association |
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Invited Speakers:
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1) PROFESSOR SIR ROY M. ANDERSON, FRS, FMEDSCI.Chair in Infectious Disease Epidemiology, Division of Epidemiology, Public Health and Primary Care, Imperial College, London. 2) CHARLES W. FLEXNER, MD.Professor of Medicine (Divisions of Clinical Pharmacology and Infectious Diseases), Pharmacology and Molecular Sciences and International Health, Johns Hopkins University.
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Deadline for Abstracts:
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-
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Registration:
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http://www.diahome.org/DIAHOME/Education/FindEducationalOffering.aspx?productID=16491&eventType=Meeting
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E-mail:
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dia@diahome.org
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