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Search results with tag "Periodic benefit risk evaluation"
ICH E2C(R2) PERIODIC BENEFIT-RISK EVALUATION …
www.jpma.or.jpich e2c(r2) periodic benefit-risk evaluation report (pbrer) （定期的ベネフィット・リスク評価報告） 厚生労働省 医薬食品局 安全対策課
PERIODIC BENEFIT-RISK EVALUATION REPORT (PBRER)
database.ich.orgThe Periodic Benefit-Risk Evaluation Report (PBRER) described in this Guideline is intended to be a common standard for periodic benefit-risk evaluation reporting on marketed products (including approved drugs that are under further study) among the ICH regions. This Guideline defines the recommended format and content of a PBRER and provides ...