메뉴 건너뛰기




Volumn 33, Issue 5, 2010, Pages 341-352

Development safety update reports and proposals for effective and efficient risk communication

Author keywords

[No Author keywords available]

Indexed keywords

DEVELOPMENT SAFETY UPDATE REPORT; DRUG INFORMATION; DRUG SAFETY; ETHICS; FOOD AND DRUG ADMINISTRATION; LIFE CYCLE; MASS COMMUNICATION; MEDICAL DOCUMENTATION; NOTE; PERIODIC SAFETY UPDATE REPORT; POSTMARKETING SURVEILLANCE; PRIORITY JOURNAL;

EID: 77951140967     PISSN: 01145916     EISSN: 11791942     Source Type: Journal    
DOI: 10.2165/11533780-000000000-00000     Document Type: Note
Times cited : (6)

References (11)
  • 1
    • 1642483123 scopus 로고    scopus 로고
    • The development safety update report (DSUR): harmonizing the format and content for periodic safety reporting during clinical trials. Report of CIOMS Working Group VII. Geneva: CIOMS
    • The Council for International Organizations of Medical Sciences. The development safety update report (DSUR): harmonizing the format and content for periodic safety reporting during clinical trials. Report of CIOMS Working Group VII. Geneva: CIOMS, 2006
    • (2006) The Council for International Organizations of Medical Sciences
  • 3
    • 77951113946 scopus 로고    scopus 로고
    • ICH harmonised tripartite guideline. Clinical safety data management: periodic safety update reports for marketed drugs E2C (R1). Current step 4 ver-sion 2005 Nov [online] [Accessed 2009 Jan 26]
    • International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use. ICH harmonised tripartite guideline. Clinical safety data management: periodic safety update reports for marketed drugs E2C (R1). Current step 4 ver-sion 2005 Nov [online]. Available from URL: http://www.ich.org/LOB/media/MEDIA477.pdf [Accessed 2009 Jan 26]
    • International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use
  • 5
    • 77951117308 scopus 로고
    • ICH harmonised tripartite guideline. Clinical safety data management: definitions and standards for ex-pedited reporting. Current step 4 version [online], [Accessed 2009 Jan 26]
    • International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use. ICH harmonised tripartite guideline. Clinical safety data management: definitions and standards for ex-pedited reporting. Current step 4 version, 1994 Oct 27 [online]. Available from URL: http://www.ich.org/LOB/media/MEDIA436.pdf [Accessed 2009 Jan 26]
    • (1994) International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use , vol.27
  • 8
    • 0033518831 scopus 로고    scopus 로고
    • Meta-analysis and epidemiologic studies in drug development and postmarketing surveillance
    • DOI 10.1001/jama.281.9.841
    • Temple R. Meta-analysis and epidemiologic studies in drug development and postmarketing surveillance. JAMA 1999; 281 (9): 841-844 (Pubitemid 29113746)
    • (1999) Journal of the American Medical Association , vol.281 , Issue.9 , pp. 841-844
    • Temple, R.1
  • 9
    • 33746861906 scopus 로고    scopus 로고
    • Pharmacovigilance during the pre-approval phases: An evolving pharmaceutical industry model in response to ICH E2E, CIOMS VI, FDA and EMEA/CHMP risk-management guidelines
    • DOI 10.2165/00002018-200629080-00003
    • Hartford CG, Petchel KS, Mickail H, et al. Pharmaco-vigilance during the pre-approval phases: an evolving pharmaceutical industry model in response to ICH E2E, CIOMS VI, FDA and EMEA/CHMP risk-management guidelines. Drug Saf 2006; 29 (8): 657-673 (Pubitemid 44175037)
    • (2006) Drug Safety , vol.29 , Issue.8 , pp. 657-673
    • Hartford, C.G.1    Petchel, K.S.2    Mickail, H.3    Perez-Gutthann, S.4    McHale, M.5    Grana, J.M.6    Marquez, P.7
  • 11
    • 77951096558 scopus 로고    scopus 로고
    • International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use. ICH harmonised tripartite guideline
    • [Accessed 2009 Jan 26] Pharmacovigilance planning E2E. Current step 4 version [online]
    • International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use. ICH harmonised tripartite guideline. Pharmacovigilance planning E2E. Current step 4 version, 2004 Nov 18 [online]. Available from URL: http://www. ich.org/LOB/media/MEDIA1195.pdf [Accessed 2009 Jan 26]
    • (2004) Nov , vol.18


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.