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Volumn 15, Issue 12, 2006, Pages 850-851

Risk management planning: Time to deliver

Author keywords

[No Author keywords available]

Indexed keywords

CERIVASTATIN; CLOZAPINE; ISOTRETINOIN; ROFECOXIB; SEROTONIN UPTAKE INHIBITOR;

EID: 33845599928     PISSN: 10538569     EISSN: 10991557     Source Type: Journal    
DOI: 10.1002/pds.1326     Document Type: Note
Times cited : (4)

References (14)
  • 1
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    • Pregnancy-Prevention Program in women of childbearing age receiving isotretinoin
    • Mitchell AA, Van Bennekom CM, Louik CA. Pregnancy-Prevention Program in women of childbearing age receiving isotretinoin. N Engl J Med 1995; 333: 101-106.
    • (1995) N Engl J Med , vol.333 , pp. 101-106
    • Mitchell, A.A.1    Van Bennekom, C.M.2    Louik, C.A.3
  • 4
    • 33746196538 scopus 로고    scopus 로고
    • Communicating about drug safety
    • Ferner RE, Aronson JK. Communicating about drug safety. Br Med J 2006; 333: 143-145.
    • (2006) Br Med J , vol.333 , pp. 143-145
    • Ferner, R.E.1    Aronson, J.K.2
  • 5
    • 0035960430 scopus 로고    scopus 로고
    • Learning from the cerivastatin experience
    • Farmer JA. Learning from the cerivastatin experience. Lancet 2001; 358: 1383-1384.
    • (2001) Lancet , vol.358 , pp. 1383-1384
    • Farmer, J.A.1
  • 6
    • 9944234075 scopus 로고    scopus 로고
    • Vioxx, the implosion of Merck, and aftershocks at the FDA
    • Horton R. Vioxx, the implosion of Merck, and aftershocks at the FDA. Lancet 2004; 364: 1995-1996.
    • (2004) Lancet , vol.364 , pp. 1995-1996
    • Horton, R.1
  • 7
    • 13844320384 scopus 로고    scopus 로고
    • Suicide, depression, and antidepressants
    • Cipriani A, Barbui C, Geddes JR. Suicide, depression, and antidepressants. Br Med J 2005; 330: 373-374.
    • (2005) Br Med J , vol.330 , pp. 373-374
    • Cipriani, A.1    Barbui, C.2    Geddes, J.R.3
  • 8
    • 0037275431 scopus 로고    scopus 로고
    • A model for the future conduct of pharmacovigilance
    • Waller PC, Evans SJW. A model for the future conduct of pharmacovigilance. Pharmacoepidemiol Drug Saf 2003; 12: 17-29.
    • (2003) Pharmacoepidemiol Drug Saf , vol.12 , pp. 17-29
    • Waller, P.C.1    Evans, S.J.W.2
  • 9
    • 84881432292 scopus 로고    scopus 로고
    • ICH Harmonised Tripartite Guideline E2E
    • ICH Harmonised Tripartite Guideline E2E. Pharmacovigilance Planning. http://www.ich.org/Mediaserver.jser?ID=1195MODE=GLB
    • Pharmacovigilance Planning
  • 10
    • 33845610757 scopus 로고    scopus 로고
    • EMEA guideline on risk management systems for medicinal products for human use
    • EMEA guideline on risk management systems for medicinal products for human use. http://www.emea.eu.int/pdfs/human/euleg/9626805en.pdf
  • 11
    • 33845669269 scopus 로고    scopus 로고
    • Pre-marketing Risk Assessment
    • FDA Guidance for Industry, March
    • Pre-marketing Risk Assessment. FDA Guidance for Industry, March 2005. http://www.fda.gov/cder/guidance/6357fnl.htm.
    • (2005)
  • 12
    • 33646151086 scopus 로고    scopus 로고
    • Development and Use of Risk Minimization Action Plans
    • FDA Guidance for Industry, March
    • Development and Use of Risk Minimization Action Plans. FDA Guidance for Industry, March 2005. http://www.fda.gov/cder/guidance/6358fnl.htm
    • (2005)
  • 13
    • 33845608977 scopus 로고    scopus 로고
    • Good Pharmacovigilance Practices and Pharmacoepidemiologic Assessment
    • FDA Guidance for Industry, March
    • Good Pharmacovigilance Practices and Pharmacoepidemiologic Assessment. FDA Guidance for Industry, March 2005. http://www.fda.gov/cder/guidance/ 6359OCC.htm
    • (2005)
  • 14
    • 33746872608 scopus 로고    scopus 로고
    • A proposal for radical changes in the drug-approval process
    • Wood AJJ. A proposal for radical changes in the drug-approval process. N Engl J Med 2005; 355: 618-623.
    • (2005) N Engl J Med , vol.355 , pp. 618-623
    • Wood, A.J.J.1


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.