Report on the joint EFPIA, DIA and EMEA pharmacogenetics workshop: Moving toward clinical application

Pharmacogenomics

Volumn 5, Issue 6, 2004, Pages 731-739

  McCarthy, Alun ^a   Kerr, M ^a   Abadie, E ^b   Chibout, S D ^c   Imbert, G ^c   Cohen, N ^d   Drakoulis, N ^e   Knudsen, L E ^f   Flamion, B ^g   Hashimoto, L ^h   Verhoofstad, W ^h   Kreutz, G ⁱ   McHale, D ^j   Mitchell, T ^b   Papaluca Amati, M ^b   Roberts, R ^k   Shaw, P ^l   Stuerzebecher, C S ^m   Townend, D ⁿ  

^a GLAXOSMITHKLINE   (United Kingdom)

^b AFSSAPs ^*  (United Kingdom)

^c Novartis Pharma AG   (Switzerland)

^d JOHNSON AND JOHNSON   (United States)

^e UNIVERSITY OF ATHENS   (Greece)

^f UNIVERSITY OF COPENHAGEN   (Denmark)

^g Ministry Public Health Med Comm   (Belgium)

^h F HOFFMANN LA ROCHE LTD   (Switzerland)

ⁱ Fed Inst Drugs and Med Devices   (Germany)

^j PFIZER GLOBAL RESEARCH AND DEVELOPMENT   (United Kingdom)

^k SANOFI   (France)

^l BRISTOL MYERS SQUIBB   (United States)

^m BAYER PHARMA AG   (Germany)

ⁿ UNIVERSITY OF SHEFFIELD   (United Kingdom)

more..

Author keywords

Development; Diagnostics; Drug; Ethics; Pharmacogenetics; Postmarketing surveillance regulatory authorities

Indexed keywords

ALOSETRON; ANTIDIABETIC AGENT; ATOMOXETINE; BCR ABL PROTEIN; CYTOCHROME P450 2D6; EPIDERMAL GROWTH FACTOR RECEPTOR 2; IMATINIB; SEROTONIN TRANSPORTER; SEROTONIN UPTAKE INHIBITOR; TRASTUZUMAB;

ARTICLE; ATTENTION DEFICIT DISORDER; BREAST CANCER; CHRONIC MYELOID LEUKEMIA; CLINICAL STUDY; CLINICAL TRIAL; CONSTIPATION; DEPRESSION; DIABETES MELLITUS; DIAGNOSTIC TEST; DRUG ABSORPTION; DRUG APPROVAL; DRUG DESIGN; DRUG EFFICACY; DRUG INDUSTRY; DRUG METABOLISM; DRUG SAFETY; ENTERITIS; EUROPEAN UNION; FLUORESCENCE IN SITU HYBRIDIZATION; FOOD AND DRUG ADMINISTRATION; HEALTH CARE POLICY; HEALTH PROGRAM; HUMAN; IMMUNOHISTOCHEMISTRY; ISCHEMIC COLITIS; LEGAL ASPECT; MEDICAL DECISION MAKING; MEDICAL ETHICS; MEDICAL RESEARCH; MEDICAL SOCIETY; PHARMACOGENETICS; POSTMARKETING SURVEILLANCE; SOCIAL ASPECT; WORKSHOP;

CLINICAL TRIALS; DECISION MAKING; DRUG DESIGN; DRUG INDUSTRY; HUMANS; PHARMACOGENETICS; PRODUCT SURVEILLANCE, POSTMARKETING;

EID: 4544369424     PISSN: 14622416     EISSN: None     Source Type: Journal    
DOI: 10.1517/14622416.5.6.731     Document Type: Article

References (8)

1. Lesko LJ, Salerno RA, Spear BB et al.: Pharmacogenetics and pharmacogenomics in drug development and regulatory decision making: report of the first FDA-PWG-PhRMA-DruSafe Workshop. J. Clin. Pharmacol. 43, 342-358 (2003).
2. Durham LK, Webb SM, Milos PM, Clary CM, Seymour AB: The serotonin transporter polymorphism, 5HTTLPR, is associated with a faster response time to sertraline in an elderly population with major depressive disorder. Psychopharmacology (Berl.) 174(4), 525-529 (2003).
3. Directive 98/79/EC of the European Parliament, Official Journal of the European Communities L331/1 (December 12, 1998).
4. Draft Guidance for Industry: Pharmacogenomic Data Submission [Docket No. 2003D-0497, 68 Federal Register, 62461-62463] (2003).
5. Directive 95/46/EC of the European Parliament and of the Council of 24 October 1995 on the protection of individuals with regard to the processing of personal data and on the free movement of such data. Official Journal L 281, 0031-0050 (1995).
6. Knudsen LE: Ethical, social and legal implications of PGt. BIOForum Europe 6, 319-321 (2003).
7. Swedish Government Bill 2001/04:44 on Biobanks in Health Service.
8. CPMP/4445/03 (January 23, 2003). Concept paper on the pharmacogenetics briefing meetings.