Blog

Investigating Unforeseen Outcomes in a Culture of Quality

June 15, 2023

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…

Upcoming Publication: Practical Considerations in Using an Equivalence Approach to Establish Lot Release Limits for Vector Dose

Publications

May 31, 2023

BioProcessing Journal has invited Dr. Janice Callahan and I to publish a second manuscript as a follow-on to a prior publication proposing an equivalence model for lot release and vector dose assignment. This preview of the work-in-progress…

Total Analytical Error (TAE) from Concept to Calculations

Quality Quarterly

March 1, 2023

Do you struggle with understanding statistical concepts applicable to your role and responsibilities in the development of biologics? Are you aware of the trend toward Bayesian statistical inference and the shift away from the frequentist…

Developments in Bioassays

Quality Quarterly

November 2, 2022

For over 30 years, I have been involved in the quality control of experimental biologics and have witnessed both incredible outcomes and tragic disappointments in addressing many different unmet clinical needs. I recently attended a conference…

Co-chair panel Bioassays and statistics FAQs to FACTS

Presentations and Panels

September 27, 2021

In 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…

Email: nancy@sajjadiconsulting.com
Phone: 703-727-9195

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