Generating and weighing evidence in drug development and regulatory decision making: 5th US FDA-DIA workshop on pharmacogenomics

Pharmacogenomics

Volumn 11, Issue 12, 2010, Pages 1629-1635

  Shaw, Peter M ^a   Zineh, Issam ^b  

^a MERCK RESEARCH LABORATORIES   (United States)

^b CENTER FOR DRUG EVALUATION AND RESEARCH   (United States)

Author keywords

co development; diagnostics; DNA sampling; drug labels; pharmaceutical company; pharmacogenetics; pharmacogenomics; prospective retrospective analysis; regulatory; US FDA; workshop

Indexed keywords

ABACAVIR; CETUXIMAB; LUMIRACOXIB; PANITUMUMAB;

ARTICLE; CLINICAL RESEARCH; DNA DETERMINATION; DRUG INDUSTRY; DRUG LABELING; DRUG RESEARCH; GENETIC ANALYSIS; HUMAN; LIVER DISEASE; MEDICAL DECISION MAKING; MEDICAL SOCIETY; PHARMACOGENETICS; PHARMACOGENOMICS; RETROSPECTIVE STUDY; WORKSHOP;

DECISION MAKING; DRUG DISCOVERY; DRUG INDUSTRY; GOVERNMENT REGULATION; PHARMACOGENETICS; POLICY MAKING; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 78650364976     PISSN: 14622416     EISSN: 17448042     Source Type: Journal    
DOI: 10.2217/pgs.10.142     Document Type: Article

References (4)

1. Surh L, Pacanowski MA, Haga SB et al.: Learning from product labels and label changes: how to build pharmacogenomics into drug development programs. Pharmacogenomics 11(12), 1637-1647 (2010)
2. Warner A, Nelsen A, Bhathena A: Enabling pharmacogenomic clinical trials through sampling. Pharmacogenomics 11(12), 1649-1654 (2010).
3. Burns DK, R Hughes AR, Power A et al.: Designing pharmacogenomic studies to be ft for purpose. Pharmacogenomics 11(12), 1657-1667 (2010).
4. Hinman L, Carl KM, Spear BB et al.: Development and regulatory strategies for drug and diagnostic co-development. Pharmacogenomics 11(12), 1669-1675 (2010).