Podcast Episodes
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Pediatric Extrapolation (Ep. 7)
Episode 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…
2 years, 9 months ago
Bioequivalence Guidances from FDA and EMA (Ep. 6)
Episode 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 bioequivalenc…
2 years, 10 months ago
Nuances of NCA (Ep. 5)
Episode 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 te…
2 years, 10 months ago
Population PK FDA guidance (Ep. 4)
Episode 4
In this episode, I discuss the 2022 FDA Guidance on Population PK analysis. This includes a discussion of the applications, methods, and submission r…
2 years, 10 months ago
Comparing NCA and PK models (Ep. 3)
Episode 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 e…
2 years, 10 months ago
Food Effect FDA Guidance (Ep 2)
Episode 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 …
2 years, 10 months ago
Podcast about clinical pharmacology (Ep 1)
Episode 1
In my inaugural episode, I introduce myself, describe the type of clinical pharmacology and pharmacometrics content I will share, let you know how to…
2 years, 10 months ago