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Abstract

REGULATORY ASPECTS OF SAFETY REPORT IN PHARMACEUTICALS

Dr. Dilip G. Maheshwari* and Ramprakash G. Parmar

ABSTRACT

In pharmaceutical industry it is essential to evaluate safety profile of pharmaceutical products during drug development and after marketing authorization. Regulatory agencies are very stringent to give marketing authorization of investigational drug for public health. That’s why regulatory agencies implement new rules for safety report. Safety report provides concise information on safety of drug. In pharmaceutical industry there are two types of safety report, Expedited safety report and aggregated safety reports. ICH provides a harmonized format for safety report to regulatory agencies that includes Expedited safety report for preclinical and post marketing safety studies, Periodic benefit and risk evaluation report (PBRER) aggregated report for marketing authorized drug and development safety update report (DSUR) aggregated report for drugs under clinical trial.

Keywords: Safety Report, Expedited, Aggregated, DSUR, PBRER.


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