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 discussed in the show: You can connect with me on LinkedIn and send me a message Send me a message Sign up…

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 allometry to extrapolate from adults to pediatrics for these antibodies. Links discussed in the show: Haray and Tachibana’s article on allometric exponents for monoclonal antibodies Exponents…

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 bioequivalence means, how the studies are designed, and then how to perform the statistical analysis. I end with some examples of…

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, and—most importantly—discuss why it matters for the decisions we make every day in drug development. Links discussed in the show: Volume of Distribution…

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 to get rid of SAS transport files in favor of Dataset JSON file formats, and how AI is being used in data programming and…

This episode is an interview with Dr. Wouter Vaes, the Chief Science Officer of Peregrion. We discuss how accelerator mass spectrometry is being used in early clinical development for drug metabolism and pharmacokinetics. We discuss using this technology to support development of oncology agents, determining absolute bioavailability without IV toxicology work, and more. Links discussed…

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 model AI tools to accelerate regulatory strategy work. Links discussed in the show: You can contact Aruna by email: arunad@regkey.ai Visit the RegKey website Connect…

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 development program is different. Links discussed in the show: You can connect with me on LinkedIn and send me a message Send me a message Sign…

In this episode I chat with Ahmed Elmokadem about QSP modeling. Ahmed, from Metrum Research Group, is an expert consultant in QSP modeling and how it can be used to provide a framework to connect mechanistic understanding with clinical pharmacology and decision-making. Links discussed in the show: Connect with Ahmed on LinkedIn on on his…

In this episode I discuss dataset-JSON, a new proposed data standard for CDISC files and explain some of the CDISC files I use in my clinical pharmacology work. I end with some brief thoughts about the ACoP 2025 meeting in Denver in October 2025. Links discussed in the show: CDISC dataset-JSON CDISC files I use…