preklininen

Preklininen is the Finnish term for the preclinical stage of biomedical research, the phase that precedes testing in humans. It encompasses laboratory experiments and animal studies intended to characterize a candidate’s biological activity, safety, and pharmacokinetic properties before any clinical trials can be initiated.

Typical activities in preclinical research include in vitro assays to assess target engagement and efficacy, pharmacokinetics and pharmacodynamics, safety pharmacology and toxicology evaluations, and early formulation and manufacturing work to support dose setting and product quality. Researchers increasingly use computational models, in vitro organ systems, and other non-animal methods to complement or reduce animal testing.

Regulatory context: Preclinical data are used to determine starting doses for human trials and to support applications for authorization to begin clinical research, such as the Investigational New Drug (IND) application in the United States or the Clinical Trial Authorization (CTA) in the European Union. Studies are commonly conducted under Good Laboratory Practice and guided by ethical principles to minimize harm, including the 3Rs framework (replacement, reduction, refinement).

Limitations: Although preclinical studies strive to predict human outcomes, they cannot fully replicate human physiology, and some adverse effects may only become apparent in clinical testing. The term preklininen is widely used in Finnish science to distinguish non-clinical research from clinical research.