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Volumn 46, Issue 3, 2008, Pages 17-20

How are drugs approved? Part 3. The stages of drug development

Author keywords

[No Author keywords available]

Indexed keywords

CLINICAL TRIAL; DRUG APPROVAL; DRUG SCREENING; FOOD AND DRUG ADMINISTRATION; HUMAN; ORGANIZATION; ORGANIZATION AND MANAGEMENT; REVIEW; SAFETY; UNITED STATES;

EID: 44049099017     PISSN: 02793695     EISSN: None     Source Type: Journal    
DOI: 10.3928/02793695-20080301-06     Document Type: Article
Times cited : (5)

References (12)
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    • The pediatric research equity act and oncology
    • Hirschfeld, S. (2004). The pediatric research equity act and oncology. Pediatric Blood & Cancer, 43, 99-102.
    • (2004) Pediatric Blood & Cancer , vol.43 , pp. 99-102
    • Hirschfeld, S.1
  • 2
    • 18844446242 scopus 로고    scopus 로고
    • Effect of study criteria on recruitment and generalizability of the results
    • Khan, A.Y., Preskorn, S.H., & Baker, B. (2005). Effect of study criteria on recruitment and generalizability of the results. Journal of Clinical Psychopharmacology, 25, 271-275.
    • (2005) Journal of Clinical Psychopharmacology , vol.25 , pp. 271-275
    • Khan, A.Y.1    Preskorn, S.H.2    Baker, B.3
  • 4
    • 13244252472 scopus 로고    scopus 로고
    • Role of pharmacoeconomic analysis in R&D decision making: When, where, how?
    • Miller, P. (2005). Role of pharmacoeconomic analysis in R&D decision making: When, where, how? PharmacoEconomics, 23, 1-12.
    • (2005) PharmacoEconomics , vol.23 , pp. 1-12
    • Miller, P.1
  • 5
    • 0038289269 scopus 로고    scopus 로고
    • Drug approvals and withdrawals over the last 60 years
    • Preskorn, S.H. (2002). Drug approvals and withdrawals over the last 60 years. Journal of Psychiatric Practice, 8, 41-50.
    • (2002) Journal of Psychiatric Practice , vol.8 , pp. 41-50
    • Preskorn, S.H.1
  • 7
    • 17144391455 scopus 로고    scopus 로고
    • The U.S. Food and Drug Administration cardiorenal advisory panel and the drug approval process
    • Roden, D.M., & Temple, R. (2005). The U.S. Food and Drug Administration cardiorenal advisory panel and the drug approval process. Circulation, 111, 1697-1702.
    • (2005) Circulation , vol.111 , pp. 1697-1702
    • Roden, D.M.1    Temple, R.2
  • 8
    • 32544452737 scopus 로고    scopus 로고
    • Drug evaluation and approval ptocess in the European Union
    • San Miguel, M.T., & Vargas, E. (2006). Drug evaluation and approval ptocess in the European Union. Arthritis and Rheumatism, 55, 12-14.
    • (2006) Arthritis and Rheumatism , vol.55 , pp. 12-14
    • San Miguel, M.T.1    Vargas, E.2
  • 9
    • 36549038142 scopus 로고    scopus 로고
    • Bolstering the FDA's drug-safety authority
    • Schultz, W.B. (2007). Bolstering the FDA's drug-safety authority. New England Journal of Medicine, 357, 2217-2219.
    • (2007) New England Journal of Medicine , vol.357 , pp. 2217-2219
    • Schultz, W.B.1
  • 10
    • 36849061688 scopus 로고    scopus 로고
    • Over the counter but no longer under the radar: Pediatric cough and cold medications
    • Sharfstein, J.M., North, M., & Serwint, J.R. (2007). Over the counter but no longer under the radar: Pediatric cough and cold medications. New England Journal of Medicine, 357, 2321-2324.
    • (2007) New England Journal of Medicine , vol.357 , pp. 2321-2324
    • Sharfstein, J.M.1    North, M.2    Serwint, J.R.3
  • 11
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    • U.S. Food and Drug Administration, (n.d.). Good clinical practice in FDA-regulated clinical trials. Retrieved February 5, 2008, from http://www.fda. gov/oc/gcp/
    • U.S. Food and Drug Administration, (n.d.). Good clinical practice in FDA-regulated clinical trials. Retrieved February 5, 2008, from http://www.fda. gov/oc/gcp/
  • 12
    • 33746872608 scopus 로고    scopus 로고
    • A proposal for radical changes in the drug-approval process
    • Wood, A.J.J. (2006). A proposal for radical changes in the drug-approval process. New England Journal of Medicine, 355, 618-623.
    • (2006) New England Journal of Medicine , vol.355 , pp. 618-623
    • Wood, A.J.J.1


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.