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Volumn 103, Issue 8, 2011, Pages 636-644

Accelerated approval of oncology products: The food and drug administration experience

Author keywords

[No Author keywords available]

Indexed keywords

ALITRETINOIN; AMIFOSTINE; ANASTROZOLE; ANTHRACYCLINE; BEXAROTENE; BICALUTAMIDE; BISPHOSPHONIC ACID DERIVATIVE; CELECOXIB; CISPLATIN; CYTARABINE; DOXORUBICIN; FLUOROURACIL; FOLINIC ACID; GEMCITABINE; GONADORELIN; IBRITUMOMAB TIUXETAN; IMATINIB; LAPATINIB; LETROZOLE; MITOXANTRONE; OXALIPLATIN; PACLITAXEL; PEMETREXED; PHOTOFRIN; PLATINUM; RAZOXANE; SORAFENIB; TAXANE DERIVATIVE; TRASTUZUMAB; UNINDEXED DRUG;

EID: 79955445696     PISSN: 00278874     EISSN: 14602105     Source Type: Journal    
DOI: 10.1093/jnci/djr062     Document Type: Review
Times cited : (184)

References (10)
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    • 21 Code of Federal Regulations, Part 314.510.
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    • 21 Code of Federal Regulations, Part 601.41
    • 21 Code of Federal Regulations, Part 601.41.
  • 3
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    • 21 Code of Federal Regulations, Part 314.126
    • 21 Code of Federal Regulations, Part 314.126.
  • 4
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    • End points and United States Food and Drug Administration approval of oncology drugs
    • DOI 10.1200/JCO.2003.08.072
    • Johnson JR, Williams G, Pazdur R. Endpoints and United States Food and Drug Administration approval of oncology drugs. J Clin Oncol. 2003;21(7):1404-1411. (Pubitemid 46606423)
    • (2003) Journal of Clinical Oncology , vol.21 , Issue.7 , pp. 1404-1411
    • Johnson, J.R.1    Williams, G.2    Pazdur, R.3
  • 5
    • 0003077113 scopus 로고
    • A regulatory authority's opinion about surrogate endpoints
    • Nimmo WS Tucker GT eds Hoboken NJ: John Wiley and Sons Ltd
    • Temple RJ. A regulatory authority's opinion about surrogate endpoints. In: Nimmo WS, Tucker GT, eds. Clinical Measurement in Drug Evaluation. Hoboken, NJ: John Wiley and Sons Ltd.; 1995:3-22.
    • (1995) Clinical Measurement in Drug Evaluation , pp. 3-22
    • Temple, R.J.1
  • 6
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    • Commentary concerning demonstration of safety and efficacy of investigational anticancer agents in clinical trials
    • O'Shaughnessy JA, Wittes RE, Burke G, et al. Commentary concerning demonstration of safety and efficacy of investigational anticancer agents in clinical trials. J Clin Oncol. 1991;9(12):2225-2232.
    • (1991) J Clin Oncol , vol.9 , Issue.12 , pp. 2225-2232
    • O'Shaughnessy, J.A.1    Wittes, R.E.2    Burke, G.3
  • 8
    • 73549117041 scopus 로고    scopus 로고
    • Running a tightrope: Regulatory challenges in the development of antiretrovirals
    • Naeger LK, Struble KA, Murray JS, Birnkrant DB. Running a tightrope: regulatory challenges in the development of antiretrovirals. Antiviral Res. 2010;85(1):232-240.
    • (2010) Antiviral Res , vol.85 , Issue.1 , pp. 232-240
    • Naeger, L.K.1    Struble, K.A.2    Murray, J.S.3    Birnkrant, D.B.4
  • 9
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    • Federal Food, Drug and Cosmetic Act (21 U.S.C. 355 (o)), Section 505 (o)
    • Federal Food, Drug and Cosmetic Act (21 U.S.C. 355 (o)), Section 505 (o).
  • 10
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    • Federal Food, Drug and Cosmetic Act (21 U.S.C. 333 (o)), Section 303 (f) (4) (A)
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* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.