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Volumn 8, Issue 2, 2011, Pages 175-182

Planning and core analyses for periodic aggregate safety data reviews

Author keywords

[No Author keywords available]

Indexed keywords

AUTHOR; CLINICAL TRIAL (TOPIC); INSTITUTIONAL REVIEW; META ANALYSIS (TOPIC); PLANNING; PRIORITY JOURNAL; REVIEW; RISK ASSESSMENT; SAFETY;

EID: 79959216544     PISSN: 17407745     EISSN: 17407753     Source Type: Journal    
DOI: 10.1177/1740774510395635     Document Type: Review
Times cited : (18)

References (13)
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    • Recommendations for safety planning, data collection, evaluation and reporting during drug, biologic and vaccine development: A report of the Safety Planning, Evaluation and Reporting Team (SPERT)
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    • Crowe, B.J.1    Xia, H.A.2    Berlin, J.A.3
  • 3
    • 33745890714 scopus 로고    scopus 로고
    • Council for International Organizations of Medical Sciences (CIOMS) Working Group VI. Geneva
    • Council for International Organizations of Medical Sciences (CIOMS) Working Group VI. Management of safety information from clinical trials, Geneva, 2005.
    • (2005) Management of Safety Information from Clinical Trials
  • 4
    • 79551566730 scopus 로고    scopus 로고
    • Reporting cumulative proportion of subjects with an adverse event based on data from multiple studies
    • Published online. DOI: 10.1002/pst.397
    • Chuang-Stein C, Beltangady M. Reporting cumulative proportion of subjects with an adverse event based on data from multiple studies. Pharma Stat 2010. Published online. DOI: 10.1002/pst.397.
    • (2010) Pharma Stat
    • Chuang-Stein, C.1    Beltangady, M.2
  • 5
    • 2942677470 scopus 로고    scopus 로고
    • Accounting for multiplicities in assessing drug safety: A three-level hierarchical mixture model
    • DOI 10.1111/j.0006-341X.2004.00186.x
    • Berry SM, Berry DA. Accounting for multiplicities in assessing drug safety: a three-level hierarchical mixture model. Biometrics 2004; 60: 418-26. (Pubitemid 38780201)
    • (2004) Biometrics , vol.60 , Issue.2 , pp. 418-426
    • Berry, S.M.1    Berry, D.A.2
  • 6
    • 79959188804 scopus 로고    scopus 로고
    • Bayesian hierarchical modeling for detecting safety signals in clinical trials
    • In press
    • Xia HA, Ma H, Carlin BP. Bayesian hierarchical modeling for detecting safety signals in clinical trials. J Biopharm Stat. In press.
    • J Biopharm Stat
    • Xia, H.A.1    Ma, H.2    Carlin, B.P.3
  • 7
    • 75149187854 scopus 로고    scopus 로고
    • Data mining and statistically guided clinical review of adverse event data in clinical trials
    • Southworth H, O'Connell M. Data mining and statistically guided clinical review of adverse event data in clinical trials. J Biopharm Stat 2009; 19: 803-17.
    • (2009) J Biopharm Stat , vol.19 , pp. 803-817
    • Southworth, H.1    O'Connell, M.2
  • 8
    • 40749105725 scopus 로고    scopus 로고
    • Graphical approaches to the analysis of safety data from clinical trials
    • DOI 10.1002/pst.254
    • Amit O, Heiberger RM, Lane PW. Graphical approaches to the analysis of safety data from clinical trials. Pharma Stat 2008; 7: 20-35. (Pubitemid 351385323)
    • (2008) Pharmaceutical Statistics , vol.7 , Issue.1 , pp. 20-35
    • Amit, O.1    Heiberger, R.M.2    Lane, P.W.3
  • 9
    • 0035897932 scopus 로고    scopus 로고
    • Forest plots: Trying to see the wood and the trees
    • Lewis S, Clarke M. Forest plots: trying to see the wood and the trees. BMJ 2001; 322: 1479-80. (Pubitemid 32575420)
    • (2001) British Medical Journal , vol.322 , Issue.7300 , pp. 1479-1480
    • Lewis, S.1    Clarke, M.2
  • 11


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.