Development and regulatory strategies for drug and diagnostic co-development

Pharmacogenomics

Volumn 11, Issue 12, 2010, Pages 1669-1675

  Hinman, Lois M ^a   Carl, Kevin M ^a   Spear, Brian B ^b   Salerno, Ronald A ^c   Becker, Robert L ^d   Abbott, Brian M ^e   Kelly, James F ^f   Mansfield, Elizabeth ^d   Katz, Russell G ^d   Harper, Courtney ^d   Day, Stephen P ^g   Pacanowski, Michael A ^d   Pignato, William ^h  

^a NOVARTIS PHARMA AG   (Switzerland)

^b ABBOTT LABORATORIES   (United States)

^c Biologics Consulting Group   (United States)

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

^e ASTRAZENECA   (United Kingdom)

^f ROCHE MOLECULAR SYSTEMS   (United States)

^g HOLOGIC INC   (United States)

^h Novartis Molecular Diagnostics LLC   (United States)

Author keywords

biomarkers; co development pharmacogenomics; companion diagnostics; drug diagnostic

Indexed keywords

ADAZAME; ANTIHYPERTENSIVE AGENT; BIOLOGICAL MARKER; DONEPEZIL; GOLOW; HLA DQA1 ANTIGEN; LUMIRACOXIB; NONSTEROID ANTIINFLAMMATORY AGENT; NOOTROPIC AGENT; UNCLASSIFIED DRUG;

ADD ON THERAPY; ALZHEIMER DISEASE; ARTICLE; CLINICAL RESEARCH; DOSE RESPONSE; DRUG EFFICACY; DRUG INDUSTRY; DRUG MARKETING; DRUG RESEARCH; DRUG SAFETY; GENETIC SCREENING; GENOTYPE; HETEROZYGOTE DETECTION; HUMAN; HYPERTENSION; LIVER TOXICITY; MEDICAL PRACTICE; MEDICAL SOCIETY; MONOTHERAPY; OSTEOARTHRITIS; PAIN; PHARMACOGENOMICS; PRACTICE GUIDELINE; PREDICTION; RISK ASSESSMENT; RISK BENEFIT ANALYSIS; WORKSHOP;

BIOMARKERS, PHARMACOLOGICAL; DIAGNOSTIC TECHNIQUES AND PROCEDURES; DRUG DESIGN; DRUG INDUSTRY; GOVERNMENT REGULATION; PHARMACOGENETICS; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 78650325817     PISSN: 14622416     EISSN: 17448042     Source Type: Journal    
DOI: 10.2217/pgs.10.141     Document Type: Article

References (5)

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4. Singer JB, Lewitzky S, Leroy E et al.: A genome-wide study identifes HLA alleles associated with lumiracoxib-related liver injury. Nat. Genet. 42, 711-714 (2010).
5. Khleif SN, Doroshow JH, Hait WN: AACR-NCI cancer biomarkers collaborative consensus report: advancing the use of biomarkers in cancer drug development. A ACR J. 16(13), 3299-3318 (2010).