Perspective: The human genome and translational research: How much evidence is enough?

Health Affairs

Volumn 27, Issue 6, 2008, Pages 1616-1618

  Woodcock, Janet ^a  

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

Author keywords

[No Author keywords available]

Indexed keywords

ABACAVIR; CARBAMAZEPINE;

ASSAY; CLINICAL PRACTICE; DRUG BLOOD LEVEL; DRUG EFFICACY; DRUG HYPERSENSITIVITY; DRUG METABOLISM; DRUG SAFETY; ENZYME ACTIVITY; FOOD AND DRUG ADMINISTRATION; GENE MUTATION; GENOMICS; HEALTH CARE COST; HEALTH CARE POLICY; HEALTH HAZARD; HUMAN; HUMAN GENOME; IN VITRO DIAGNOSTIC INDEXED MULTIPLEXED ASSAY; IN VITRO STUDY; LABORATORY TEST; MEDICAL RESEARCH; MEDICAL TECHNOLOGY; PHARMACOGENOMICS; PRACTICE GUIDELINE; REIMBURSEMENT; REVIEW; SCREENING TEST; STEVENS JOHNSON SYNDROME; ARTICLE; EVIDENCE BASED MEDICINE; GENETIC SCREENING; GENETICS; PHARMACOGENETICS;

EVIDENCE-BASED MEDICINE; GENETIC RESEARCH; GENETIC SCREENING; GENOME, HUMAN; HUMANS; PHARMACOGENETICS;

EID: 56649105060     PISSN: 02782715     EISSN: 02782715     Source Type: Journal    
DOI: 10.1377/hlthaff.27.6.1616     Document Type: Review

References (4)

1. M.J. Khoury et al., "The Evidence Dilemma in Genomic Medicine," Health Affairs 27, no. 6 (2008): 1600-1611.
2. Food and Drug Administration, "Information on Abacavir (Marketed as Ziagen) and Abacavir-containing Medications," 24 July 2008, http://www.fda.gov/cder/drug/infopage/abacavir (accessed 20 August 2008);
3. and FDA, "Information on Carbamazepine (Marketed as Carbatrol, Equetro, Tegretol, and Generics)," 31 January 2008, http://www.fda.gov/ cder/drug/infopage/carbamazepine (accessed 20 August 2008).
4. FDA, "Draft Guidance for Industry, Clinical Laboratories, and FDA Staff: In Vitro Diagnostic Multivariate Index Assays," 26 July 2007, http://www.fda.gov/cdrh/oivd/guidance/1610.pdf (accessed 20 August 2008).