title: Best practices for the development, scale-up, and post-approval change control of IR and MR dosage forms in the current quality-by-design paradigm.
abstract: In this whitepaper, the Manufacturing Technical Committee of the Product Quality Research Institute provides information on the common, best practices in use today in the development of high-quality chemistry, manufacturing and controls documentation. Important topics reviewed include International Conference on Harmonization, in vitro-in vivo correlation considerations, quality-by-design approaches, process analytical technologies and current scale-up, and process control and validation practices. It is the hope and intent that this whitepaper will engender expanded dialog on this important subject by the pharmaceutical industry and its regulatory bodies.
authors.affiliation: Nonclinical Drug Development Consulting Services, LLC, Basking Ridge, New Jersey, 07920, USA, glennvb@optonline.net.
authors.forename: Glenn A
authors.initials: GA
authors.lastname: Van Buskirk
authors.forename: Satish
authors.initials: S
authors.lastname: Asotra
authors.forename: Christopher
authors.initials: C
authors.lastname: Balducci
authors.forename: Prabir
authors.initials: P
authors.lastname: Basu
authors.forename: Gerald
authors.initials: G
authors.lastname: DiDonato
authors.forename: Angelica
authors.initials: A
authors.lastname: Dorantes
authors.forename: W Mark
authors.initials: WM
authors.lastname: Eickhoff
authors.forename: Tapash
authors.initials: T
authors.lastname: Ghosh
authors.forename: Mario A
authors.initials: MA
authors.lastname: González
authors.forename: Theresa
authors.initials: T
authors.lastname: Henry
authors.forename: Matthew
authors.initials: M
authors.lastname: Howard
authors.forename: Jason
authors.initials: J
authors.lastname: Kamm
authors.forename: Steven
authors.initials: S
authors.lastname: Laurenz
authors.forename: Ryan
authors.initials: R
authors.lastname: MacKenzie
authors.forename: Richard
authors.initials: R
authors.lastname: Mannion
authors.forename: Patrick K
authors.initials: PK
authors.lastname: Noonan
authors.forename: Terrance
authors.initials: T
authors.lastname: Ocheltree
authors.forename: Umesh
authors.initials: U
authors.lastname: Pai
authors.forename: Richard P
authors.initials: RP
authors.lastname: Poska
authors.forename: Michael L
authors.initials: ML
authors.lastname: Putnam
authors.forename: Ramani R
authors.initials: RR
authors.lastname: Raghavan
authors.forename: Colleen
authors.initials: C
authors.lastname: Ruegger
authors.forename: Eric
authors.initials: E
authors.lastname: Sánchez
authors.forename: Vinod P
authors.initials: VP
authors.lastname: Shah
authors.forename: Zezhi Jesse
authors.initials: ZJ
authors.lastname: Shao
authors.forename: Russell
authors.initials: R
authors.lastname: Somma
authors.forename: Vijay
authors.initials: V
authors.lastname: Tammara
authors.forename: Avinash G
authors.initials: AG
authors.lastname: Thombre
authors.forename: Bruce
authors.initials: B
authors.lastname: Thompson
authors.forename: Robert J
authors.initials: RJ
authors.lastname: Timko
authors.forename: Satyam
authors.initials: S
authors.lastname: Upadrashta
authors.forename: Sivakumar
authors.initials: S
authors.lastname: Vaithiyalingam
mesh_terms: D000818:Animals; D019985:Benchmarking / Q000592:standards*; D002626:Chemistry, Pharmaceutical / Q000592:standards; D003692:Delayed-Action Preparations / Q000592:standards; D017277:Drug Approval; D004345:Drug Industry / Q000379:methods / Q000592:standards*; D005079:Excipients / Q000737:chemistry / Q000592:standards; D006801:Humans; D004364:Pharmaceutical Preparations / Q000008:administration & dosage / Q000737:chemistry / Q000592:standards*; D010599:Pharmacokinetics; D011786:Quality Control; D018570:Risk Assessment; D012995:Solubility; D013678:Technology, Pharmaceutical / Q000379:methods / Q000592:standards*; D014116:Toxicology / Q000592:standards; D014481:United States; D014486:United States Food and Drug Administration
chemical_list: D003692:Delayed-Action Preparations; D005079:Excipients; D004364:Pharmaceutical Preparations