title: Regulatory Science and Drug Approval for Alcoholic and Nonalcoholic Steatohepatitis.
authors.affiliation: Department of Medicine, VCU School of Medicine, Richmond, Virginia. Electronic address: arun.sanyal@vcuhealth.org.
authors.forename: Arun J
authors.initials: AJ
authors.lastname: Sanyal
authors.affiliation: University of California School of Public Health, Berkeley, California.
authors.forename: Veronica
authors.initials: V
authors.lastname: Miller
mesh_terms: D000818:Animals; D002986:Clinical Trials as Topic / Q000331:legislation & jurisprudence; D017277:Drug Approval / Q000331:legislation & jurisprudence; D055808:Drug Discovery / Q000331:legislation & jurisprudence / Q000379:methods*; D023381:Endpoint Determination; D005235:Fatty Liver, Alcoholic / Q000175:diagnosis / Q000188:drug therapy*; D006801:Humans; D065626:Non-alcoholic Fatty Liver Disease / Q000175:diagnosis / Q000188:drug therapy*; D011050:Policy Making; D012107:Research Design / Q000331:legislation & jurisprudence; D016896:Treatment Outcome
keywords: Alcoholic Hepatitis; Clinical Trials; Drug Approval; Drug Development; End Points; Nonalcoholic Steatohepatitis; Regulatory Science; Trial Design