PK/PD Modeling & Simulation

Blood or Plasma? Which Should You Assay for Drug Concentration?

Nathan Teuscher

Since modern drug development, drug concentration assays have almost exclusively used plasma as a matrix rather than whole blood. Various theories about assay sensitivity, matrix interference, protein binding, and free drug movement have been put forth to explain why it is “best” to measure drug concentrations in plasma. Personally none of these theories convinces me […]

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Topics: PK/PD Modeling & Simulation

Why Should You Evaluate Dose Proportionality?

Nathan Teuscher

Dose proportionality is a common phrase used pharmacokinetics. Early in the pre-clinical development process, we evaluate dose proportionality in animal species. Then if the drug advances to clinical trials, one of the first assessments in humans is to evaluate dose proportionality. Why is it so important? What do we learn from understanding dose proportionality? What […]

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Topics: PK/PD Modeling & Simulation

What is the Difference Between PK and TK?

Nathan Teuscher

PK is the abbreviation for pharmacokinetics. TK is the abbreviation for toxicokinetics. Some consider these to be distinct specialties while others consider them to be the same. Let me explain and then I would like to see what you think. Pharmacokinetics generally deals with doses that are in a therapeutic range. Thus common dose ranges […]

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Topics: PK/PD Modeling & Simulation

Why are PK Parameters Lognormally Distributed?

Nathan Teuscher

The statistical analysis of pharmacokinetic parameters is often overlooked and not always well understood. The disconnect between the pharmacokineticist and the biostatistician can often be a huge stumbling block that prevents the appropriate analysis of PK parameters. While I cannot solve all the disagreements between pharmacokineticists and biostatisticians in a single blog post, I hope […]

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Topics: PK/PD Modeling & Simulation

What are Direct and Indirect Pharmacodynamic Models?

Nathan Teuscher

When constructing pharmacodynamic (PD) models, you will often encounter the adjectives “direct” and “indirect” describing the associated PD model. This terminology was very confusing to me when I was learning about PD modeling. Hopefully a brief explanation will help you. Let’s start with the direct PD model. In this type of model, the drug is […]

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Topics: PK/PD Modeling & Simulation

What is Modeling and Simulation?

Nathan Teuscher

I am currently attending a short conference on modeling and simulation in pediatric clinical pharmacology, and I noticed that many people in the conference don’t have a good grasp on what “Modeling and Simulation” means. I think most of them think that it is an extremely complicated mathematical concoction that is intended to keep everyone […]

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Topics: PK/PD Modeling & Simulation
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