Pharmacogenetics and pharmacogenomics in drug development and regulatory decision making: report of the first FDA-PWG-PhRMA-DruSafe Workshop.

Full Abstract

The use of pharmacogenetics and pharmacogenomics in the drug development process, and in the assessment of such data submitted to regulatory agencies by industry, has generated significant enthusiasm as well as important reservations within the scientific and medical communities. This situation has arisen because of the increasing number of exploratory and confirmatory investigations into variations in RNA expression patterns and DNA sequences being conducted in the preclinical and clinical phases of drug development, and the uncertainty surrounding the acceptance of these data by regulatory agencies. This report summarizes the outcome of a workshop cosponsored by the Food and Drug Administration (FDA), the Pharmacogenetics Working Group (PWG), the Pharmaceutical Research and Manufacturers of America (PhRMA), and the PhRMA Preclinical Safety Committee (DruSafe). The specific aim of the workshop was to identify key issues associated with the application of pharmacogenetics and pharmacogenomics, including the feasibility of a regulatory "safe harbor" for exploratory genome-based data, and to provide a forum for industry-regulatory agency dialogue on these important issues.

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Author information

Author/s: Lesko, Lawrence J (LJ); Salerno, Ronald A (RA); Spear, Brian B (BB); Anderson, Donald C (DC); Anderson, Timothy (T); Brazell, Celia (C); Collins, Jerry (J); Dorner, Andrew (A); Essayan, David (D); Gomez-Mancilla, Baltazar (B); Hackett, Joseph (J); Huang, Shiew-Mei (SM); Ide, Susan (S); Killinger, Joanne (J); Leighton, John (J); Mansfield, Elizabeth (E); Meyer, Robert (R); Ryan, Stephen G (SG); Schmith, Virginia (V); Shaw, Peter (P); Sistare, Frank (F); Watson, Mark (M); Worobec, Alexandra (A);

Affiliation: Food and Drug Administration, Center for Drug Evaluation and Research, Rockville, Maryland, USA.

Journal and publication information

Publication Type: Journal Article

Journal: Journal of clinical pharmacology (J Clin Pharmacol), published in United States. (Language: eng)

Reference: 2003-Apr; vol 43 (issue 4) : pp 342-58

Dates: Created 2003/05/01; Completed 2003/07/31; Revised 2007/11/15;

PMID: 12723455, status: MEDLINE (last retrieval date: 12/26/2008)

Sourced from the National Library of Medicine. Abstract text and other information may be subject to copyright.

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MeSH headings (categories)

This article was linked to the MESH Headings shown below.

Clinical Trials as Topic - methods; standards
Decision Making
Drug Design
Genomics - legislation & jurisprudence; methods; standards
Guidelines as Topic
Humans
Pharmacogenetics - legislation & jurisprudence; methods; standards

Pharmacogenetics - legislation & jurisprudence; methods; standards
Pharmacology
Policy Making
Research Design - standards; trends
Safety - standards
United States
United States Food and Drug Administration - standards

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