In this episode, I discuss two data analysis techniques: (1) non-compartmental analysis or NCA, and (2) PK modeling. I discuss the basic premise of each method and similarities and differences between them. Links discussed in the show: Publication about NCA by Johan Gabrielsson and Dan Weiner Publication about PK modeling by Hartmut Derendorf et. al….

In this episode, I discuss the 2022 FDA guidance on food effect studies. I discuss the timing of these studies in your development programs, various aspects of study design, and some unique exceptions to the standard food effect study. Links discussed in the show: • Here’s the current FDA guidance for food effect studies •…

In my inaugural episode, I introduce myself, describe the type of clinical pharmacology and pharmacometrics content I will share, let you know how to get in touch with me, and give the reason why I started this podcast. Links discussed in the show: You can connect with me on LinkedIn and send me a message…