
Co-chair panel Bioassays and statistics FAQs to FACTS
Presentations and PanelsIn this session, Nancy Sajjadi and Steve Walfish introduce 4 speakers and posit several questions to address hot topics in bioassay design, development and validation: Generating and evaluating the standard curve, establishing equivalence…

AAPS Keynote Philadelphia
Presentations and PanelsIn this presentation, Nancy describes how %CV is an often used, but poor metric for relating assay performance, reported value measurement uncertainty and fitness-for-purpose. She presents a biomarker case study to show how assay suitability…

Dose Escalation Studies: How to Deal with Variability in Vector Dose Measurements
Presentations and PanelsIn this presentation, Nancy explains that pre-clinical and clinical trials involving dose escalation assume that the assigned dose values are comparable across studies. However, dose assays for vectors often have high variability. Nancy discusses…