title: Bioanalytical method validation for macromolecules in support of pharmacokinetic studies.
abstract: The development and validation of ligand binding assays used in the support of pharmacokinetic studies has been the focus of various workshops and publications in recent years, all in an effort to establish a guidance document for standardization of these bioanalytical methods. This summary report of the workshop from 2003 focuses on the issues discussed in presentations and notes points of discussion and areas of consensus among the participants.
authors.affiliation: Alta Analytical Laboratory, San Diego, California, USA. josmolec@alta-immunochem.com
authors.forename: JoMarie
authors.initials: J
authors.lastname: Smolec
authors.forename: Binodh
authors.initials: B
authors.lastname: DeSilva
authors.forename: Wendell
authors.initials: W
authors.lastname: Smith
authors.forename: Russell
authors.initials: R
authors.lastname: Weiner
authors.forename: Marian
authors.initials: M
authors.lastname: Kelly
authors.forename: Ben
authors.initials: B
authors.lastname: Lee
authors.forename: Masood
authors.initials: M
authors.lastname: Khan
authors.forename: Richard
authors.initials: R
authors.lastname: Tacey
authors.forename: Howard
authors.initials: H
authors.lastname: Hill
authors.forename: Abbie
authors.initials: A
authors.lastname: Celniker
authors.forename: Vinod
authors.initials: V
authors.lastname: Shah
authors.forename: Ronald
authors.initials: R
authors.lastname: Bowsher
authors.forename: Anthony
authors.initials: A
authors.lastname: Mire-Sluis
authors.forename: John W A
authors.initials: JW
authors.lastname: Findlay
authors.forename: Mary
authors.initials: M
authors.lastname: Saltarelli
authors.forename: Valerie
authors.initials: V
authors.lastname: Quarmby
authors.forename: David
authors.initials: D
authors.lastname: Lansky
authors.forename: Robert
authors.initials: R
authors.lastname: Dillard
authors.forename: Martin
authors.initials: M
authors.lastname: Ullmann
authors.forename: Stephen
authors.initials: S
authors.lastname: Keller
authors.forename: H Thomas
authors.initials: HT
authors.lastname: Karnes
mesh_terms: D002138:Calibration; D002623:Chemistry Techniques, Analytical; D010599:Pharmacokinetics; D012015:Reference Standards; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity