Finding a job in Clinical Pharmacology (Ep. 9)
This episode I talk about finding a job in Clinical Pharmacology or Pharmacometrics. I share a few thoughts from my experience followed by an interview with TJ Elder, the president of STEM Sourcing Re...
11 Sep 202343min
QT Prolongation Guidance ICH E14 (Ep. 8)
This episode is a discussion of the FDA and ICH guidance E14 titled “Clinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential for Non-Antiarrhythmic Drugs”. I start with backgro...
28 Aug 202330min
Pediatric Extrapolation (Ep. 7)
Thank you to everyone who sent me feedback on this podcast. This episode is based on a suggestion from Kushal and Parmesh. In this episode, I discuss a general clinical pharmacology pediatric extrapol...
14 Aug 202324min
Bioequivalence Guidances from FDA and EMA (Ep. 6)
Thank you to everyone who sent me feedback on this podcast. This episode is based on a suggestion from Drew. In this episode, I discuss bioequivalence studies and generic drug development. I will refe...
24 Juli 202330min
Nuances of NCA (Ep. 5)
In this episode, I discuss some nuances of non-compartmental analysis or NCA. I am going to focus on three separate parameters: Cmax, AUC, and the terminal elimination rate constant. These three are t...
10 Juli 202320min
Population PK FDA guidance (Ep. 4)
In this episode, I discuss the 2022 FDA Guidance on Population PK analysis. This includes a discussion of the applications, methods, and submission requirements for population PK models. Links discus...
3 Juli 202336min
Comparing NCA and PK models (Ep. 3)
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...
3 Juli 202317min
Food Effect FDA Guidance (Ep 2)
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...
3 Juli 202317min
