Model diagnostics and selection (Ep. 11)
This episode is a discussion on model evaluation and selection. I discussed diagnostic plots using predictions and residuals. I covered approaches for model selection and factors to consider. The focu...
9 Okt 202331min
Exposure-Response FDA Guidance (Ep. 10)
This episode is a discussion of the FDA guidance “Exposure-Response Relationships”. The relationship between drug exposure and response is critical to any determination of the safety and effectiveness...
25 Sep 202324min
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 Jul 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 Jul 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 Jul 202336min
