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Volumn 42, Issue 2, 2002, Pages 137-143

Oncology drug development: United States Food and Drug Administration perspective

Author keywords

Drug approval; Drug development; FDA; Regulatory agency

Indexed keywords

AMIFOSTINE; ANASTROZOLE; ARSENIC TRIOXIDE; CAPECITABINE; CELECOXIB; CLADRIBINE; CYTARABINE; DOCETAXEL; DOXORUBICIN; EXEMESTANE; IMATINIB; IRINOTECAN; LETROZOLE; MITOXANTRONE; PAMIDRONIC ACID; PENTOSTATIN; PHOTOFRIN; RAZOXANE; RETINOIC ACID; TAMOXIFEN CITRATE; TEMOZOLOMIDE; TOPOTECAN; TOREMIFENE;

EID: 0036242837     PISSN: 10408428     EISSN: None     Source Type: Journal    
DOI: 10.1016/S1040-8428(02)00008-2     Document Type: Review
Times cited : (35)

References (24)
  • 1
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    • Food, Drug & Cosmetic Act as amended United States Code Title 21 Chapter 9
  • 2
    • 0008954447 scopus 로고    scopus 로고
    • Federal Advisors Committee Act Public Law 92-463, 6 October 1972
  • 3
    • 0008892005 scopus 로고    scopus 로고
    • Public Health Service Act United States Code Title 42 Chapter 6A
  • 4
    • 0008892881 scopus 로고    scopus 로고
    • Food And Drug Administration Modernization Act Of 1997 Public Law 105-115 105th Congress 21 November 1997
  • 5
    • 0008932534 scopus 로고    scopus 로고
    • Code of Federal Regulations, Title 21: Parts 300-499
  • 13
    • 0008892541 scopus 로고    scopus 로고
    • Subpart H, Accelerated Approval of New Drugs for Serious or Life-Threatening Illnesses. 21 Code of Federal Regulations 314.510, 1 April 1999
  • 15
    • 0034594628 scopus 로고    scopus 로고
    • New Guidelines to evaluate the response to treatment in solid tumors
    • European Organization for Research and Treatment of Cancer, National Cancer Institute of the United States, National Cancer Institute of Canada
    • (2000) J Natl Cancer Inst , vol.92 , Issue.3 , pp. 205-216
    • Therasse, P.1    Arbuck, S.G.2    Eisenhauer, E.A.3
  • 17
    • 0008925476 scopus 로고    scopus 로고
    • Code of Federal Regulations, Title 21, Part 316
  • 19
    • 0008903054 scopus 로고    scopus 로고
    • Pediatric studies of drugs, Section 111 Of The Food And Drug Modernization Act 21 United States Code 355a (1997)


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.