title: Safety and efficacy: the role of chemistry, manufacturing, and controls in pharmaceutical drug development.
authors.affiliation: ChemPharm CMC Sciences & Dossier Management, Johnson & Johnson Pharmaceutical Research and Development, LLC, Spring House, Pennsylvania 19002, USA. tdifeo@prdus.jnj.com
authors.forename: Thomas J
authors.initials: TJ
authors.lastname: DiFeo
mesh_terms: D000818:Animals; D055598:Chemical Phenomena; D002627:Chemistry, Physical; D002986:Clinical Trials as Topic / Q000379:methods; D015195:Drug Design; D004353:Drug Evaluation, Preclinical; D005079:Excipients / Q000737:chemistry; D006801:Humans; D004364:Pharmaceutical Preparations / Q000737:chemistry*; D011786:Quality Control; D013678:Technology, Pharmaceutical / Q000379:methods
chemical_list: D005079:Excipients; D004364:Pharmaceutical Preparations