A willingness to investigate unwelcome results is integral to building and maintaining a culture of quality.
My first two Quality Quarterly issues focused on bioassays and total analytical error. I chose these topics because the resolving…
https://sajjadiconsulting.com/wp-content/uploads/2023/06/Qq3Image2.png5641128Jill Kurtzhttps://sajjadiconsulting.com/wp-content/uploads/2021/08/sajjadi-logo-web.pngJill Kurtz2023-06-15 08:50:452023-06-15 08:54:22Investigating Unforeseen Outcomes in a Culture of Quality
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…
https://firstname.lastname@example.org://email@example.com 14:33:312021-09-28 09:47:23AAPS Keynote Philadelphia
In this interview, Nancy describes her unconventional journey to becoming a scientist and how her early childhood experiences influenced her recent decision to expand the scope of her business. She gives her insights into the quality challenges…
https://firstname.lastname@example.org://email@example.com 13:58:482021-09-23 16:34:27CHI podcast The Chain Interview June 2021
In 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…
https://firstname.lastname@example.org://email@example.com 15:16:122021-09-28 09:47:59Dose Escalation Studies: How to Deal with Variability in Vector Dose Measurements
This open access article was co-authored with my statistical consultant colleague of 30+ years. In it we propose using an equivalence approach for lot release testing of vector products. Because dose related toxicity is a concern, dose assays…
https://firstname.lastname@example.org://email@example.com 15:18:312023-05-31 10:38:19Defining Therapeutic Window for Viral Vectors: A Statistical Framework to Improve Consistency in Assigning Product Dose Values
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