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The role of quantitative safety evaluation in regulatory decision making of drugs

Aloka G Chakravarty1, Rima Izem1, Stephine Keeton1

  • 1a Division of Biometrics VII, Office of Biostatistics , Center for Drug Evaluation and Research, US Food and Drug Administration , Silver Spring , Maryland , USA.

Journal of Biopharmaceutical Statistics
|September 16, 2015
PubMed

Keywords:
Evaluation of risk from extended/long-acting opioidslarge safety outcome trialsmeta-analysis for safety evaluationpost-marketing requirementsquantitative safety evaluationthe sentinel initiative

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