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Volumn 26, Issue 5, 2017, Pages 597-599

Periodic benefit-risk evaluation reports have substantial promise to guide patient care and should be made publicly available

Author keywords

[No Author keywords available]

Indexed keywords

RIVAROXABAN; WARFARIN;

EID: 85013188102     PISSN: 10538569     EISSN: 10991557     Source Type: Journal    
DOI: 10.1002/pds.4177     Document Type: Note
Times cited : (3)

References (9)
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    • 85017911224 scopus 로고    scopus 로고
    • [Accessed 2 October 2016]
    • U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center for Biologics Evaluation and Research (CBER). E2C(R2) periodic benefit risk evaluation report (PBRER) guidance for industry, 2016. http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm299513.pdf [Accessed 2 October 2016].
    • (2016) E2C(R2) periodic benefit risk evaluation report (PBRER) guidance for industry
  • 5
    • 85017901378 scopus 로고    scopus 로고
    • [Accessed 14 Jan 2017]
    • The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use. About ICH, 2016. http://www.ich.org/home.html. [Accessed 14 Jan 2017].
    • (2016) About ICH
  • 6
    • 79958036418 scopus 로고    scopus 로고
    • Characteristics of clinical trials to support approval of orphan vs nonorphan drugs for cancer
    • Kesselheim AS, Myers JA, Avorn J. Characteristics of clinical trials to support approval of orphan vs nonorphan drugs for cancer. JAMA 2011; 305(22): 2320–2326.
    • (2011) JAMA , vol.305 , Issue.22 , pp. 2320-2326
    • Kesselheim, A.S.1    Myers, J.A.2    Avorn, J.3
  • 7
    • 77956625112 scopus 로고    scopus 로고
    • A basic study design for expedited safety signal evaluation based on electronic healthcare data
    • Schneeweiss S. A basic study design for expedited safety signal evaluation based on electronic healthcare data. Pharmacoepidemiol Drug Saf 2010; 19(8): 858–868.
    • (2010) Pharmacoepidemiol Drug Saf , vol.19 , Issue.8 , pp. 858-868
    • Schneeweiss, S.1
  • 8
    • 84993124440 scopus 로고    scopus 로고
    • The active comparator, new user study design in pharmacoepidemiology: historical foundations and contemporary application
    • Lund JL, Richardson DB, Stürmer T. The active comparator, new user study design in pharmacoepidemiology: historical foundations and contemporary application. Curr Epidemiol Rep 2015; 2(4): 221–228.
    • (2015) Curr Epidemiol Rep , vol.2 , Issue.4 , pp. 221-228
    • Lund, J.L.1    Richardson, D.B.2    Stürmer, T.3


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.