title: The European clinical trials directive-a regulatory approach for filing drug substance information.
authors.affiliation: CMC Sciences and Dossier Management, Johnson & Johnson Pharmaceutical Research and Development, Springhouse, Pennsylvania, USA.
authors.forename: Debbie
authors.initials: D
authors.lastname: Lettani
authors.forename: Thomas J
authors.initials: TJ
authors.lastname: DiFeo
mesh_terms: D002626:Chemistry, Pharmaceutical / Q000331:legislation & jurisprudence*; D002986:Clinical Trials as Topic / Q000331:legislation & jurisprudence*; D004339:Drug Compounding; D004355:Drug Stability; D015507:Drugs, Investigational; D005062:European Union
chemical_list: D015507:Drugs, Investigational