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Volumn 7, Issue 4, 2008, Pages 263-269

Conditional approval: Discussion points from the PSI Conditional Approval Expert Group

Author keywords

Conditional approval; HIV; Oncology

Indexed keywords

ARTICLE; CLINICAL RESEARCH; CONDITIONAL APPROVAL; CONSULTATION; DRUG APPROVAL; DRUG DEVELOPMENT; DRUG INDUSTRY; DRUG RESEARCH; EUROPE; HUMAN IMMUNODEFICIENCY VIRUS; INFORMATION DISSEMINATION; LAW; MEDICAL EXPERT; ONCOLOGY; OUTCOME ASSESSMENT; PRACTICE GUIDELINE; SYSTEMATIC ERROR;

EID: 57849114811     PISSN: 15391604     EISSN: 15391612     Source Type: Journal    
DOI: 10.1002/pst.309     Document Type: Article
Times cited : (5)

References (6)
  • 2
    • 57849085029 scopus 로고    scopus 로고
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    • Sutent Scientific Discussion. Available at: www.emea.europa.eu/humandocs/ pdfs/EPAR/sutent/06870en6.pdf (accessed 21.06.2007).
    • Sutent Scientific Discussion
  • 3
    • 33747813779 scopus 로고    scopus 로고
    • Food and Drug Administration, Centre for Drug Evaluation and Research, Electronic document available at:, accessed 21.06.2007
    • Food and Drug Administration, Centre for Drug Evaluation and Research. Guidance for Industry: Clinical Trial Endpoints for the Approval of Cancer Drugs and Biologics. Electronic document available at: http://www.fda.gov/cder/guidance/7478fnl.htm (accessed 21.06.2007).
    • Guidance for Industry: Clinical Trial Endpoints for the Approval of Cancer Drugs and Biologics
  • 5
    • 57849086658 scopus 로고    scopus 로고
    • European Medicines Agency, Committee for Medicinal Products. Guideline on the Clinical Development of Medicinal Products for the Treatment of HIV Infection (CPMP/EWP/633/02, Rev. 1). Electronic document available at: http://www.emea.europa.eu/pdfs/human/ewp/063302en.pdf (accessed 25.04.2007).
    • European Medicines Agency, Committee for Medicinal Products. Guideline on the Clinical Development of Medicinal Products for the Treatment of HIV Infection (CPMP/EWP/633/02, Rev. 1). Electronic document available at: http://www.emea.europa.eu/pdfs/human/ewp/063302en.pdf (accessed 25.04.2007).
  • 6
    • 33744956374 scopus 로고    scopus 로고
    • Tenofovir DF and emtricitabine vs. zidovudine and lamivudine: Letter to the editor
    • Laessig KA, Lewis LL, Hammerstrom TS. Tenofovir DF and emtricitabine vs. zidovudine and lamivudine: letter to the editor. New England Journal of Medicine 2006; 254(23):2506-2507.
    • (2006) New England Journal of Medicine , vol.254 , Issue.23 , pp. 2506-2507
    • Laessig, K.A.1    Lewis, L.L.2    Hammerstrom, T.S.3


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.