Program safety analysis plan: An implementation guide

Quantitative Evaluation of Safety in Drug Development: Design, Analysis and Reporting

Volumn , Issue , 2014, Pages 55-68

  Crowe, Brenda ^a   Xia, H Amy ^b   Nilsson, Mary ^a   Shahin, Seta ^b   Wang, Wei ^a   Jiang, Qi ^b,c  

^a ELI LILLY AND COMPANY   (United States)

^b AMGEN INC   (United States)

^c AMERICAN STATISTICAL ASSOCIATION   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

EID: 84944078987     PISSN: None     EISSN: None     Source Type: Book    
DOI: 10.1201/b17846     Document Type: Chapter

References (12)

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8. Nilsson, M.E. and Koke, S.C. 2001. Defining treatment-emergent adverse events with the medical dictionary for regulatory activities. Drug Information Journal, 35, 1289-1299.
9. Pharmaceutical Users Software Exchange. 2013. PhUSE standard scripts working group site. Available: http://www.phusewiki.org/wiki/index.php?title= Standard_Scripts. Accessed August 1, 2014.
10. Rochester, C. G. 2009. Lifecycle planning for safety evaluation. FDA/Industry Statistics Workshop, Washington, DC.
11. U.S. Food and Drug Administration. 2009. Guidance for industry: Drug-induced liver injury: Premarketing clinical evaluation. Available: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM174090.pdf. Accessed August 1, 2014.
12. Xia, H.A., Crowe, B.J., Schriver, R.C., Oster, M., and Hall, D.B. 2011. Planning and core analyses for periodic aggregate safety data reviews. Clinical Trials, 8, 175-182.