
Investigating Unforeseen Outcomes in a Culture of Quality
Quality QuarterlyA 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…

Total Analytical Error (TAE) from Concept to Calculations
Quality QuarterlyDo 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 QuarterlyFor 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…