Clinical Pharmacology Podcast with Nathan Teuscher
Nathan Teuscher
I discuss clinical pharmacology and pharmacometrics topics from the perspective of drug development scientists. I share my expertise and knowledge about designi...
In this episode I discuss power calculations using the R package PowerTOST. I gave an introduction to power calculations and the statistical premise. I reviewed bioequivalence study designs that are commonly used for generic drug development, food effect evaluation, and drug-drug interaction studies.
Links discussed in the show:
PowerTOST R package
PowerTOST instructions (scroll down to the Read Me information)
Example R code (Change the filetype to .R after downloading)
Statistical Power
Statistical approaches to establishing Bioequivalence from FDA
Calculation of CV
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34:39
Collaboration with BioTalk Unzipped (Ep. 40)
In this episode I share a couple short clips from my conversation with Chad Briscoe and Greg Austin from BioTalk Unzipped (www.biotalkunzipped.com). We chat about a variety of topics including artificial intelligence and challenges with cell therapy development. You can hear the entire conversation on the BioTalk Unizipped podcast or YouTube channel in January. For now, enjoy these clips from the upcoming show!
Links discussed in the show:
BioTalk Unzipped main page
BioTalk Unzipped YouTube channel
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13:53
Toxicokinetics (Ep. 39)
In this episode I discuss toxicokinetic analysis. This is the analysis of exposure data to support animal toxicology studies. I review the purpose of toxicology studies and how exposure metrics are used. Then I discuss different blood sampling schemes, and how to calculate exposure parameters for both full profiles and mean profiles.
Links discussed in the show:
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19:03
Steady State (Ep. 38)
This episode is a discussion of steady state pharmacokinetics. Steady state occurs when the amount of drug input is equivalent to the amount of drug elimination in a dosing interval. I discuss some key PK parameters at steady state and how to use them. I also discuss different methods of confirming that you have reached steady state.
Links discussed in the show:
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16:27
Dose Proportionality (Ep. 37)
In this episode I talk about dose proportionality, which is a surrogate for determining if we have linear clearance across a range of dose levels. I discuss 3 different methods that people use to determine dose proportionality along with a recommendation to use the power model method.
Links discussed in the show:
Power model method
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About Clinical Pharmacology Podcast with Nathan Teuscher
I discuss clinical pharmacology and pharmacometrics topics from the perspective of drug development scientists. I share my expertise and knowledge about designing and conducting clinical pharmacology studies and discuss how to analyze the data using the most effective approaches. I draw from my experience of over 20 years working in drug development organizations and consultancies.
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