Blog

The Importance of Reference Standard Management Programs in Drug Development

PDF Version For those who liked (or missed) my attempt at a beach read, you can download QQ#4 on significant figures in PDF format. Not everyone enjoys nor needs to get into the nitty gritty of calculations, but some appreciated being walked…

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

BioProcessing Journal  has published a second manuscript by Dr. Janice Callahan and I as a follow-on to a prior publication proposing an equivalence model for lot release and vector dose assignment. This latest publication outlines the scope…

NIST-FDA Workshops on Measurements and Standards for Advanced Therapy

See the details for NIST-FDA Workshops on Measurements and Standards for Advanced Therapy, held November 2023.
Significant Figures, Quality Quarterky 4

Significant Figures

PDF Version If this issue goes out according to schedule, it will be precisely 0.8876712328767120 years since I launched the Quality Quarterly. I want to mark this ~1 year anniversary by thanking those who have taken time to reply to the…

BIOASSAY — FROM FRAMEWORK TO FAQs

See the details for presentation at Optimizing Bioassays for Biologics, held October 2023.