In this episode I review the process I follow for fitting a base pharmacokinetic (PK) model. I talk from the perspective of an individual PK model, but include some differences associated with population PK models. I go over exploratory data analysis, getting initial estimates, and how to choose between different base models.Links discussed in the show:AIC and BICYou can connect with me on LinkedIn and send me a message Send me a message Sign up for my newsletter Copyright Teuscher Solutions LLCAll Rights Reserved
--------
27:40
Different estimation methods used in modeling (Ep. 44)
In this episode I discuss different algorithms used for pharmacometrics modeling. I describe difference between maximum likelihood and expectation maximization methods. I review the FO and FOCEI maximum likelihood algorithms. I then review SAEM, IMP, and QRPEM expectation maximization algorithms that are available. I conclude with an brief explanation of the difference between parameter estimation and parameter uncertainty. Links discussed in the show:PMXRepoJames Ousey LinkedIn pageManuscript by Liu and Wang, 2016You can connect with me on LinkedIn and send me a messageSend me a messageSign up for my newsletterCopyright Teuscher Solutions LLCAll Rights Reserved
--------
25:37
What is consulting life like? (Ep. 43)
In this episode I discuss my experience as an independent consultant in the clinical pharmacology and pharmacometrics space. I talk about how I got from high school to become a consultant. I touched on the many different activities I do as an independent consultant. I shared a bit about how I handle compensation with clients and how I pay myself. And I ended with some brief comments about getting customers. Links discussed in the show:Time management with Clockify Accounting and invoices with Wave Project management with Jira Project notes with Confluence Computing resources with AWS Microsoft 365 for email, sharepoint, and more as a small business Profit First You can connect with me on LinkedIn and send me a message Send me a message Sign up for my newsletter Copyright Teuscher Solutions LLCAll Rights Reserved
--------
30:05
Population PK modeling with nlmixr (Ep. 42)
In this episode I discuss using nlmixr for population PK modeling in R. I give an overview of the software package, describe the installation process, and walk through a simple example. Overall, nlmixr is a nice package that can be used for most modeling activities you encounter. It eliminates the need for a license since it is open-source. There are some challenges associated with using R for modeling with large datasets and long-running models. But once those are overcome, this could be a great package for all-around use. Links discussed in the show: nlmixr website nlmixr on github Example R code – remove the .txt file type after download You can connect with me on LinkedIn and send me a message Send me a message Sign up for my newsletterCopyright Teuscher Solutions LLCAll Rights Reserved
--------
25:55
Sample size calculations (Ep. 41)
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
You can connect with me on LinkedIn and send me a message
Send me a message
Sign up for my newsletter
Copyright Teuscher Solutions LLC
All Rights Reserved
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.
Listen to Clinical Pharmacology Podcast with Nathan Teuscher, More or Less: Behind the Stats and many other podcasts from around the world with the radio.net app