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Bioequivalence Testing: The Stats Behind Generic Drug Approvals (Ep. 57)
Episode 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 …
12 hours ago
Examining Volume of Distribution (Ep. 56)
Episode 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 act…
1 month ago
Talking about data science with Mike Stackhouse (Ep. 55)
Episode 55
This episode is an interview with Michael Stackhouse, the Chief Innovation Officer at Atorus Research. We discussed a variety of topics such as moder…
2 months, 1 week ago
Using Accelerator Mass Spectrometry in Clinical Pharmacology
Episode 54
This episode is an interview with Dr. Wouter Vaes, the Chief Science Officer of Peregrion. We discuss how accelerator mass spectrometry is being used…
3 months, 1 week ago
Using AI tools for regulatory intelligence (Ep. 53)
Episode 53
This episode is an interview with Aruna Dhontabhaktuni, Founder and CEO of RegKey, a regulatory intelligence platform that uses AI. The discussion to…
4 months ago
When to use model-informed drug development (Ep. 52)
Episode 52
This episode is a collection of my thoughts on model-informed drug development and where different modeling modalities fit into the development sched…
5 months ago
QSP Modeling with Ahmed Elmokadem (Ep. 51)
Episode 51
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…
6 months ago
CDISC datasets and ACoP 2025 (Ep. 50)
Episode 50
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 pharmac…
6 months, 4 weeks ago
Statistics in Pharmacokinetics (Ep. 49)
Episode 49
In this episode I discuss review statistics that are commonly used in pharmacokinetics and pharmacometrics work. I reviewed the basic theory of the n…
8 months ago
Clinical Trial Simulations (Ep. 48)
Episode 48
In this episode I discuss clinical trial simulations. I review concepts of trial simulation including different variability terms and when to use the…
9 months ago