title: The central role of chemistry in 'quality by design' approaches to drug development.
abstract: The quality of medicines reaching the consumer is strictly controlled and maintained by the regulatory agencies of the world. Pharmaceutical companies have to meet and maintain these regulatory quality standards. For this purpose, an increasing number of processes are incorporating quality by design (QbD) principles. Implementation of QbD involves chemistry in several ways, such as in the development of new synthetic and analytical methods, avoiding formation of genotoxic impurities and designing drug-like compounds to improve the quality of biological profile of medicines. A combined effort from regulatory authorities, pharmaceutical industries and academic research groups could also facilitate QbD implementation.
authors.affiliation: Department of Chemistry, University of Connecticut, 55 North Eagleville Road, Storrs, CT 06269-3060, USA.
authors.forename: Neha K
authors.initials: NK
authors.lastname: Grewal
authors.forename: Nicholas E
authors.initials: NE
authors.lastname: Leadbeater
mesh_terms: D060326:Chemistry Techniques, Synthetic / Q000379:methods / Q000592:standards; D004340:Drug Contamination; D015195:Drug Design; D055772:Green Chemistry Technology / Q000379:methods / Q000592:standards; D006801:Humans; D004364:Pharmaceutical Preparations / Q000737:chemistry* / Q000592:standards; D011786:Quality Control; D013678:Technology, Pharmaceutical / Q000379:methods* / Q000592:standards
chemical_list: D004364:Pharmaceutical Preparations