Allometry in Pediatrics and First in Human Studies (Ep. 17)
Happy New Year! Today’s episode is all about allometric scaling in pharmacokinetic and pharmacodynamics. In particular, I’ll discuss how to use it for scaling from adults to pediatrics and for selecti...
8 Jan 202417min
Computer System Validation for Pharmacometrics (Ep. 16)
This is the last podcast for 2023. Thank you for listening throughout the year! In today’s episode I talk about computer system validation for pharmacometrics. I review my experience with validation i...
25 Dec 202330min
QSP, PBPK, PKPD, PopPK … analysis abbreviation soup! (Ep. 15)
In today’s episode I cover 4 different modeling approaches: QSP, PBPK, PopPK, and PKPD. All of these are methods for analyzing data to predict either drug concentrations, or a response variable. But e...
11 Dec 202326min
Handling BLQ samples (Ep. 13)
In today’s episode I discuss BLQ handing for both non-compartmental and modeling analysis approaches. I discuss how BLQ samples are defined, methods for analyzing them, and situations when you should ...
27 Nov 202322min
Clinical Drug Interaction Studies (Ep. 14)
In today’s episode I covered the different types of drug interactions, followed by features of clinical drug evaluation studies recommended in the guidance. Then I will review recommendations for both...
27 Nov 202319min
PK in patients with impaired renal function (Ep. 12)
In today’s episode I discuss the evaluation of pharmacokinetics in patients with impaired renal function. I include information from both the US FDA and EMA guidance documents linked below. I discuss ...
23 Okt 202314min
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
