Large molecule specific assay operation: recommendation for best practices and harmonization from the global bioanalysis consortium harmonization team.
The L2 Global Harmonization Team on large molecule specific assay operation for protein bioanalysis in support of pharmacokinetics focused on the following topics: setting up a balanced validation design, specificity testing, selectivity testing, dilutional linearity, hook effect, parallelism, and testing of robustness and ruggedness. The team additionally considered the impact of lipemia, hemolysis, and the presence of endogenous analyte on selectivity assessments as well as the occurrence of hook effect in study samples when no hook effect had been observed during pre-study validation.
Biogen Idec, 14 Cambridge Center, Cambridge, Massachusetts, 02142, USA, Lauren.Stevenson@biogenidec.com.
Lauren
L
Stevenson
Marian
M
Kelley
Boris
B
Gorovits
Clare
C
Kingsley
Heather
H
Myler
Karolina
K
Osterlund
Arumugam
A
Muruganandam
Yoshiyuki
Y
Minamide
Mario
M
Dominguez
D002623:Chemistry Techniques, Analytical / Q000592:standards*; D017410:Practice Guidelines as Topic; D011506:Proteins / Q000032:analysis*; D054928:Validation Studies as Topic
D011506:Proteins