Pharmacogenomics: Will the regulators approve? Regulatory agencies face new challenges with the advent of drugs targeted at subgroups of the population

Nature Biotechnology

Volumn 16, Issue 3, 1998, Pages 243-246

  Hodgson, John ^a   Marshall, Andrew ^a  

^a NONE

Author keywords

[No Author keywords available]

Indexed keywords

BIOLOGICAL FACTOR; CYTOCHROME P450; DRUG;

DRUG APPROVAL; DRUG CONTROL; DRUG LEGISLATION; FOOD AND DRUG ADMINISTRATION; GOVERNMENT; PHARMACOGENETICS; PRIORITY JOURNAL; SHORT SURVEY;

CLINICAL TRIALS; CYTOCHROME P-450 ENZYME SYSTEM; DRUG APPROVAL; DRUG INDUSTRY; EUROPE; GENETICS, POPULATION; GUIDELINES; HUMANS; JAPAN; LONDON; PHARMACOGENETICS; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION; VARIATION (GENETICS);

EID: 0031951486     PISSN: 10870156     EISSN: None     Source Type: Journal    
DOI: 10.1038/nbt0398-243     Document Type: Short Survey

References (3)

1. Marshall A. 1997. Nature Biotechnology 15:954-957.
2. Department of Health and Human Services, US Food and Drug Administration. 1997. Guidance for Industry. Drug Metabolism/Drug Interaction Studies in the Drug Development Process: Studies in Vitro. The Drug Information Branch (HFD-210), Rockville, MD.
3. Meyer, U.A. 1997. Medically relevant genetic variation of drug effects. Evolution in Health and Disease. Oxford University Press, Oxford, UK.