Regulatory perspectives

Abstract

I. Introduction II. Pre-and Nonclinical Research and Development III. Controlled Clinical Trials IV. New Drug Application (NDA) Review and Approval V. Marketing and Surveillance of New Drugs VI. Detection of Hepatotoxicity Before and After Approval VII. Idiosyncracy or Intrinsically Hepatotoxic Drug? VIII. Does Preexisting Liver Disease Increase the Risk for Drug-Induced Hepatic Injury? IX. Does Monitoring Prevent Serious Drug-Induced Hepatotoxicity? X. What Needs To Be Done?