Dosresponsstudier

Dosresponsstudier, or dose–response studies, are experiments or analyses that examine how the magnitude of a biological or toxic effect changes with varying doses of a substance. The central aim is to characterize the dose–response relationship and to identify doses that achieve desired effects with acceptable safety, or doses that induce adverse effects for risk assessment.

These studies can be conducted in vitro (cell or tissue systems), in vivo in animal models, or in humans through clinical dose-ranging or early-phase trials. Typical designs include multiple dose groups, defined administration routes, and a measurable endpoint such as receptor activity, biomarker change, clinical symptoms, or mortality. Data are used to construct dose–response curves, which can be graded (continuous outcome) or quantal (all-or-nothing outcomes).

Key concepts include potency, often summarized by the EC50 or IC50, efficacy (the maximum effect), and the slope of the curve. Models such as the Hill equation or logistic functions are commonly applied to estimate parameters and to compare substances or formulations. A parallel set of terms, NOAEL (no observed adverse effect level) and LOAEL (lowest observed adverse effect level), frequently appear in toxicology applications.

Applications of dosresponsstudier span drug development, toxicology, and environmental health risk assessment. They inform dosing recommendations, safety margins, and regulatory labeling. Limitations include challenges in extrapolating across species, variability among individuals, and potential nonmonotonic dose responses, which require careful interpretation. See also pharmacodynamics and toxicology.