Empirical PK/PD
What is Empirical PK/PD?
Empirical PK/PD modeling is a data-driven approach that relates drug concentration (pharmacokinetics) and drug effect (pharmacodynamics) based on observed data. The selection of mathematical expressions is driven by the observed data. There are a few commonly used models, such as Emax, logistic regression, direct response and indirect response models. Empirical PK/PD can also be referred to as traditional PK/PD or classical PK/PD.
When to use Empirical PK/PD
Empirical PK/PD modeling can be applied at both preclinical and clinical stages once PK and PD data is available. Here are some examples of when they are applied:
- Characterize exposure vs. efficacy relationship in mice
- Characterize exposure vs. toxicity relationship from toxicity studies
- Characterize exposure vs. PD relationship in animal or human studies
- Help understand the translation of PK/PD relationship from preclinical to clinical
- Predict PK and PD at new dose levels or dosing regimen
Empirical PK/PD models focus on fitting the data with the simplest model needed. It often takes less time than mechanistic models and may provide a better fit to the data. However, it will not provide mechanistic understanding when comparing across different compounds, different experiments, or different patient populations, except determining if a difference exists. It is also best used when interpolating between doses instead of extrapolating to higher dose levels that have never been tested. Given the limitations, it can still be a very useful tool when quick characterization of the data is needed.
Free Consultation
What scientific questions are you trying to answer? We'll put you in touch with the right person on our team.