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Variability of Ligand Binding Assays Used for PK Protein Drug Bioanalysis – Database Collected as a Follow-up to the 2006 AAPS Crystal City III Workshop
Tuesday, November 13
9:00 am – 11:00 am
Roundtable
ACPE #073-999-07-517-l04
Ligand binding assays (LBA) are generally recognized to be less precise than chromatographic-based assays, such as LC-MS. However, no data have been collected and analyzed systematically to date to investigate method variability and its impact on decision making for application in PK assessments of biotherapeutics. At the AAPS 2006 Crystal City III Workshop, a 4-6-20 rule was suggested as a default QC run acceptance criteria for LBAs based on the ‘comfort zone’ from historical assay data. Accordingly, it is appropriate at this juncture to systematically evaluate retrospective data to define an appropriate default run acceptance rule for LBAs. Several members of the AAPS Ligand Binding Assay Bioanalytical Focus Group and PQRI have worked together to share data to permit statistical analysis for evaluating variability, bias, total error and other technical LBA performance characteristics. The information gathered will provide a ‘realistic’ picture of assay performance and variability of LBA and offer statistically appropriate default criteria for LBA run acceptance. It would help the pharmaceutical industry to identify the norm, evaluate method acceptability, and to develop optimal acceptance criteria for the intended applications. This roundtable will present the initial pilot datasets to estimate the required size of database and preliminary results of the work.
Moderators
Ronald Bowsher, Ph.D.
LINCO Diagnostic Services, Inc.
Wendell Smith, Ph.D.
B2S Stats
Introduction Historical Perspective. Objective and Cope of the Work for Bioanalytical IA Variance Assessment. Why is it worthwhile?
Jean W. Lee, Ph.D.
Amgen, Inc.
Results of Pilot Dataset – and How This Led to the Design of a Larger Data Set
Bruno Boulanger, Ph.D.
Eli Lilly and Company
Preliminary Data from PQRI – The Lessons Learned and Where Do We Go From Here
Mario Rocci, Ph.D.
Prevalere Life Sciences