title: Quality by design: concepts for ANDAs.
abstract: Quality by design is an essential part of the modern approach to pharmaceutical quality. There is much confusion among pharmaceutical scientists in generic drug industry about the appropriate element and terminology of quality by design. This paper discusses quality by design for generic drugs and presents a summary of the key terminology. The elements of quality by design are examined and a consistent nomenclature for quality by design, critical quality attribute, critical process parameter, critical material attribute, and control strategy is proposed. Agreement on these key concepts will allow discussion of the application of these concepts to abbreviated new drug applications to progress.
authors.affiliation: Food and Drug Administration, Office of Generic Drugs, 7519 Standish Place, Rockville, Maryland, 20855, USA.
authors.forename: Robert A
authors.initials: RA
authors.lastname: Lionberger
authors.forename: Sau Lawrence
authors.initials: SL
authors.lastname: Lee
authors.forename: Laiming
authors.initials: L
authors.lastname: Lee
authors.forename: Andre
authors.initials: A
authors.lastname: Raw
authors.forename: Lawrence X
authors.initials: LX
authors.lastname: Yu
mesh_terms: D015195:Drug Design; D004345:Drug Industry / Q000592:standards*; D016568:Drugs, Generic / Q000592:standards*; D011786:Quality Control; D014481:United States; D014486:United States Food and Drug Administration
chemical_list: D016568:Drugs, Generic