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…

In this episode I discuss review statistics that are commonly used in pharmacokinetics and pharmacometrics work. I reviewed the basic theory of the normal distribution and then discussed various individual statistics that we use in PK work. I concluded with some examples of which statistics I use in my work. Links discussed in the show:…

In this episode I discuss clinical trial simulations. I review concepts of trial simulation including different variability terms and when to use them. I also share my thoughts on 3 different applications used in clinical trial simulation. Links discussed in the show: Trial Simulator Software page Simulx Software page You can connect with me on…