Abstract: Drug Utilization and Safety Evaluation: Lessons Learned from International Multinational Retrospective Chart Review Study Applications

 

Abstract: Drug Utilization and Safety Evaluation: Lessons Learned from International Multinational Retrospective Chart Review Study Applications

Increasingly, to meet marketing authorization and risk management data needs, regulators are requiring real world prescription pattern data including empirical off label-use. In the absence of suitable databases, chart review studies can result in robust datasets appropriate for evaluations of drug utilization and safety outcomes.