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Allometry in Pediatrics and First in Human Studies (Ep. 17)
Episode 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 fo…
2 years, 4 months ago
Computer System Validation for Pharmacometrics (Ep. 16)
Episode 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 pharma…
2 years, 5 months ago
QSP, PBPK, PKPD, PopPK … analysis abbreviation soup! (Ep. 15)
Episode 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…
2 years, 5 months ago
Handling BLQ samples (Ep. 13)
Episode 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 …
2 years, 5 months ago
Clinical Drug Interaction Studies (Ep. 14)
Episode 14
In today’s episode I covered the different types of drug interactions, followed by features of clinical drug evaluation studies recommended in the gu…
2 years, 5 months ago
PK in patients with impaired renal function (Ep. 12)
Episode 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 …
2 years, 7 months ago
Model diagnostics and selection (Ep. 11)
Episode 11
This episode is a discussion on model evaluation and selection. I discussed diagnostic plots using predictions and residuals. I covered approaches fo…
2 years, 7 months ago
Exposure-Response FDA Guidance (Ep. 10)
Episode 10
This episode is a discussion of the FDA guidance “Exposure-Response Relationships”. The relationship between drug exposure and response is critical t…
2 years, 8 months ago
Finding a job in Clinical Pharmacology (Ep. 9)
Episode 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 intervi…
2 years, 8 months ago
QT Prolongation Guidance ICH E14 (Ep. 8)
Episode 8
This episode is a discussion of the FDA and ICH guidance E14 titled “Clinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential …
2 years, 8 months ago