Bioanalytical method validation for macromolecules in support of pharmacokinetic studies.
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.
Smolec
JoMarie
J
Alta Analytical Laboratory, San Diego, California, USA. josmolec@alta-immunochem.com
DeSilva
Binodh
B
Smith
Wendell
W
Weiner
Russell
R
Kelly
Marian
M
Lee
Ben
B
Khan
Masood
M
Tacey
Richard
R
Hill
Howard
H
Celniker
Abbie
A
Shah
Vinod
V
Bowsher
Ronald
R
Mire-Sluis
Anthony
A
Findlay
John W A
JW
Saltarelli
Mary
M
Quarmby
Valerie
V
Lansky
David
D
Dillard
Robert
R
Ullmann
Martin
M
Keller
Stephen
S
Karnes
H Thomas
HT
D002138:Calibration; D002623:Chemistry Techniques, Analytical; D010599:Pharmacokinetics; D012015:Reference Standards; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity