Renal and Hepatic Impairment (Ep. 59)
Today’s episode is a discussion of renal and hepatic impairment. I review the biology of the kidney and liver and how we analyze pharmacokinetic data to assess their impact on drug exposure. Links dis...
24 Elo 28min
Beyond Small Molecules—Allometric Scaling for Biologics and Engineered mAbs (Ep. 58)
Today’s episode is about allometric scaling with therapeutic antibodies. I discuss differences from small molecules, how to handle antibodies with engineered Fc regions (e.g. YTE or LS), and using all...
27 Heinä 20min
Bioequivalence Testing: The Stats Behind Generic Drug Approvals (Ep. 57)
In this episode I discuss bioequivalence testing and how it was developed to support generic drug approvals, but is now a mainstream tool for all of drug development. I discuss the basics of what bioe...
25 Touko 24min
Examining Volume of Distribution (Ep. 56)
In this episode we’re going to define Volume of Distribution, look at the different types of Volume of Distribution parameters, talk about how we actually calculate it, examine what drives its value, ...
20 Huhti 19min
Talking about data science with Mike Stackhouse (Ep. 55)
This episode is an interview with Michael Stackhouse, the Chief Innovation Officer at Atorus Research. We discussed a variety of topics such as modern data science tools, why regulatory agencies want ...
16 Maalis 45min
Using AI tools for regulatory intelligence (Ep. 53)
This episode is an interview with Aruna Dhontabhaktuni, Founder and CEO of RegKey, a regulatory intelligence platform that uses AI. The discussion touches on how companies can leverage large language ...
19 Tammi 21min
When to use model-informed drug development (Ep. 52)
This episode is a collection of my thoughts on model-informed drug development and where different modeling modalities fit into the development schedule. These are just my opinions and each developmen...
22 Joulu 202528min
