title: Large molecule run acceptance: Recommendation for best practices and harmonization from the Global Bioanalysis Consortium Harmonization Team.
abstract: The L1 Global Harmonization Team provides recommendations specifically for run acceptance of ligand binding methods used in bioanalysis of macromolecules in support of pharmacokinetics. The team focused on standard curve calibrators and quality controls for use in both pre-study validation and in-study sample analysis, including their preparation and acceptance criteria. The team also considered standard curve editing and the concept of total error.
authors.affiliation: MKelley Consulting LLC, 1533 Glenmont Lane, West Chester, Pennsylvania, 19380, USA, mmk48@Comcast.net.
authors.forename: Marian
authors.initials: M
authors.lastname: Kelley
authors.forename: Christopher
authors.initials: C
authors.lastname: Beaver
authors.forename: Lauren F
authors.initials: LF
authors.lastname: Stevenson
authors.forename: Ross
authors.initials: R
authors.lastname: Bamford
authors.forename: Paula
authors.initials: P
authors.lastname: Gegwich
authors.forename: Yamamoto
authors.initials: Y
authors.lastname: Katsuhiko
authors.forename: Dongbei
authors.initials: D
authors.lastname: Li
authors.forename: Samantha
authors.initials: S
authors.lastname: Little
authors.forename: Arumugam
authors.initials: A
authors.lastname: Muruganandam
authors.forename: Daniela
authors.initials: D
authors.lastname: Stoellner
authors.forename: Ravi Kumar
authors.initials: RK
authors.lastname: Trivedi
mesh_terms: D046911:Macromolecular Substances / Q000032:analysis*; D017410:Practice Guidelines as Topic; D011786:Quality Control; D054928:Validation Studies as Topic
chemical_list: D046911:Macromolecular Substances