AAPS 2021 PHarmSCi 360 Keynote

American Association of Pharmaceutical Scientists PharmSci360
DATE:October 16-19. 2022

Presentation Slides (PDF)

In 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 is inextricably linked to a statistical hypothesis framework and demonstrates how assay validation data can be used to define and evaluate assay performance criteria.

A PDF slide deck is being made available to promote use of the proposed approach.  Please note this presentation and its content are protected by copyright laws.All rights reserved. You may view and download this presentation for personal use or share this presentation with others for educational purposes, provided proper attribution is given to Sajjadi Consulting. Please seek permission for any other use not covered here.Unauthorized use or reproduction of any part of this presentation without prior written permission is strictly prohibited.