Workshop on Bioanalytical Methods Validation for Macromolecules: Summary Report

1. To determine industry and regulatory standards established for bioanalytical method validation in support of the estimation and characterization of macromolecules in the preclinical and clinical stages of drug development. 2. To evaluate special validation considerations for quantitative, macromolecule-detecting technologies that have emerged since 1990 including immunoassays, cell-based assays, antibody titers, and automation in the laboratory. 3. To address the strengths/limitations and advantages/ disadvantages of assay-customized approaches to validation that focus on assay parameters specific to the intended use of the assay. 4. To develop a 2000 workshop report regarding appropriate bioanalytical validation criteria and standardization of terminology for the above to be used by regulatory agencies to draft new guidelines for the bioanalytical validation criteria for macromolecules quantitation.