Simulations (Ep. 27)
This episode discusses simulations. I group simulations into 4 categories: (1) average response, (2) population, (3) individual, and (4) clinical trial simulations. I discuss details of each of these ...
10 Jun 202420min
Different work environments (Ep. 26)
Today’s show is about different work environments and not scientific topics. Throughout my career I have worked in many different types of companies, and I would like to share some observations with y...
27 Mai 202435min
Biosimilar products (Ep. 25)
Today’s show discussed biosimilar development from a clinical pharmacology perspective. I describe what biosimilar products are and the necessary comparisons to the reference product. I review require...
13 Mai 202416min
Choosing an absorption model (Ep. 24)
Today’s show discussed approaches for modeling absorption profiles. I discussed the rationale behind modeling absorption and then described some common models. These included first-order absorption, z...
22 Apr 202424min
What is Aplos NCA? (Ep. 23)
Today’s show was an overview of Aplos Analytics and the development story for Aplos NCA. Please consider participating in the Early Access Program. Use the link below to learn more about Aplos NCA. Li...
8 Apr 202429min
Big announcement and Hepatic impairment studies (Ep. 22)
Today’s show is about hepatic impairment clinical studies. I cover the rationale behind evaluating hepatic impairment, common study designs, and key factors in the analysis and interpretation of the s...
25 Mar 202418min
Project Optimus (Ep. 21)
Today’s episode was about Project Optimus, the FDA initiative to improve dose selection and optimization for oncology products. Julie Bullock was a guest on this episode and shared her expertise as a ...
11 Mar 202439min
Tackling TMDD Models (Ep. 20)
Today’s show is about TMDD or target-mediated drug disposition models. I review the scientific and physiologic basis for TMDD models, how to review data and determine if a TMDD model is needed. I revi...
26 Feb 202415min
