Pathology Primers

Q: What is pharmacometrics?

Pharmacometrics is the science of quantitative pharmacology that uses mathematical models to describe and predict drug behavior in patients. It combines pharmacokinetics (what the body does to the drug) and pharmacodynamics (what the drug does to the body) to optimize drug development and dosing.

Q: What is NONMEM used for?

NONMEM (NONlinear Mixed Effects Modeling) is specialized software for population pharmacokinetic/pharmacodynamic modeling. It's used to analyze drug concentration-time data from clinical trials to understand variability between patients and optimize dosing regimens.

Q: How is pharmacometrics used in drug development?

Pharmacometrics supports drug development by predicting optimal doses, identifying patient populations likely to benefit, designing efficient clinical trials, and supporting regulatory submissions with quantitative evidence of drug efficacy and safety.

Disease facts that are good to know

Each primer provides a concise, high-level summary of a disease relevant to pharmacometricians, focusing on biomarkers, drug regimens, and modeling approaches.

Typical structure for disease “XYZ”:

What is XYZ?

Disease definition & pathophysiology
Commonly used Pharmacodynamic (PD) Models (e.g., disease progression models, target engagement)

Patient characteristics

Typical patient population
Risk factors & disease progression indicators

Diagnosis & biomarkers

Key Clinical Biomarkers (e.g., lab values, thresholds, imaging)
Disease Severity Classification (if applicable, e.g., staging systems)

How can XYZ be treated?

Treatment aim (PD-targets)
Common Drug Classes & Regimens
- Mechanism of Action (MoA)
- First-line vs. second-line treatments
- Dose Adjustments (e.g., renal/liver impairment, pediatrics)
Commonly used PK-models