title: ICH3: a report and background.
authors.affiliation: Queen's University of Belfast.
authors.forename: P F
authors.initials: PF
authors.lastname: D'Arcy
mesh_terms: D017277:Drug Approval / Q000458:organization & administration*; D005060:Europe; D006801:Humans; D007391:International Cooperation; D007564:Japan; D011786:Quality Control; D012449:Safety; D014481:United States