Home » ICH Updates Safety Guideline With Periodic Benefit-Risk Evaluation Reports
ICH Updates Safety Guideline With Periodic Benefit-Risk Evaluation Reports
April 6, 2012
Drugmakers should provide separate estimates of cumulative and interval patient exposure to marketed drugs and provide justification when an estimate of the number of patients exposed can’t be obtained, according to an International Conference on Harmonisation (ICH) draft guideline on periodic benefit-risk evaluation reports (PBRER).
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