Enabling pharmacogenomic clinical trials through sampling

Pharmacogenomics

Volumn 11, Issue 12, 2010, Pages 1649-1654

  Warner, Amelia ^a   Nelsen, Anita ^b   Bhathena, Anahita ^c   Fitzgerald, Kevin ^d   Gilardi, Sandra ^e   Kelso, Ellen ^f   Knoppers, Bartha ^g   McLeod, Howard L ^h   Nelson, Robert ⁱ   Uyama, Yoshi ^j   Weisman, Jennifer ^k   Rudman, Allen ⁱ  

^a MERCK RESEARCH LABORATORIES   (United States)

^b GLAXOSMITHKLINE   (United States)

^c ABBOTT LABORATORIES   (United States)

^d GEORGETOWN UNIVERSITY   (United States)

^e BRISTOL MYERS SQUIBB   (United States)

^f Goodwyn Institutional Review Board   (United States)

^g MCGILL UNIVERSITY   (Canada)

^h UNIVERSITY OF NORTH CAROLINA   (United States)

ⁱ CENTER FOR DRUG EVALUATION AND RESEARCH   (United States)

^j PHARMACEUTICALS AND MEDICAL DEVICES AGENCY   (Japan)

^k Office for Civil Rights   (United States)

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Author keywords

clinical trials; drug development; international coordination; pharmacogenomics; regulatory; sample collection

Indexed keywords

ARTICLE; CLINICAL RESEARCH; CODING; DECISION MAKING; DRUG INDUSTRY; DRUG INFORMATION; DRUG MARKETING; DRUG RESEARCH; GENETIC ANALYSIS; HUMAN; LAW; MEDICAL SOCIETY; PATIENT EDUCATION; PHARMACOGENOMICS; PRIMARY MEDICAL CARE; SAMPLING;

CLINICAL TRIALS AS TOPIC; DRUG DESIGN; DRUG INDUSTRY; GOVERNMENT REGULATION; INTERNATIONAL COOPERATION; PHARMACOGENETICS; SAMPLING STUDIES; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 78650379600     PISSN: 14622416     EISSN: 17448042     Source Type: Journal    
DOI: 10.2217/pgs.10.139     Document Type: Article

References (10)

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2. The National Research Act: Protection of Human Subjects. Public Law 93-348. 98th Congress. (July 1974).
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5. Food and Drugs: Code of Federal Regulations. Department of Health and Human Services. Protection of Human Subjects 21 CRF Part 50 April 2010 (Revised).
6. Food and Drugs: Code of Federal Regulations. Department of Health and Human Services. Institutional Review Boards 21 CRF Part 56 April 2010 (Revised).
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9. Pediatric Research Equity Act of 2003. Public Law 108-155. 108th Congress. (December 2003).
10. Wendler D: One-time general consent for research on biological samples. BMJ 332, 544-557 (2006).