Workshop report and follow-up--AAPS Workshop on current topics in GLP bioanalysis: Assay reproducibility for incurred samples--implications of Crystal City recommendations.
The Conference Report of the 3rd AAPS/FDA Bioanalytical Workshop (Crystal City III) endorsed the concept that assay methods supporting bioanalytical data in submissions must demonstrate assay reproducibility by using incurred samples. The present Workshop was convened to provide a forum for discussion and consensus building about incurred sample assay reproducibility for both nonclinical and clinical studies. Information about current regulatory perspectives on incurred sample reanalysis (ISR) was presented, implications of ISR for both large and small molecules were discussed, and the steering committee put forth recommendations for performing ISR. These recommendations from the Workshop, along with the subsequent evolution of approaches leading to a robust ISR program, may be used by scientists performing bioanalytical assays for regulated studies to provide additional confirmation of assay reproducibility for incurred samples.
Fast
Douglas M
DM
Pharmacokinetics, Dynamics, and Metabolism, Pfizer Inc., MS-8118D-2061, Eastern Point Road, Groton, Connecticut 06340, USA. douglas.m.fast@pfizer.com
Kelley
Marian
M
Viswanathan
C T
CT
O'Shaughnessy
Jacqueline
J
King
S Peter
SP
Chaudhary
Ajai
A
Weiner
Russell
R
DeStefano
Anthony J
AJ
Tang
Daniel
D
D053000:Analytic Sample Preparation Methods; D000818:Animals; D001681:Biological Assay / Q000592:standards*; D017408:Guidelines as Topic; D006801:Humans; D004364:Pharmaceutical Preparations / Q000032:analysis* / Q000378:metabolism; D010599:Pharmacokinetics; D015203:Reproducibility of Results
D004364:Pharmaceutical Preparations