Preklinikk

Preklinikk, often translated as the preclinical phase, is the stage of biomedical research conducted before a new drug, device, or therapy is tested in humans. The aim is to characterize safety and potential efficacy using laboratory experiments and animal studies.

The work includes in vitro studies such as cell assays to assess biological activity and toxicity, in vajo studies to evaluate safety, pharmacokinetics (absorption, distribution, metabolism, elimination) and pharmacodynamics, and the development of formulation and manufacturing processes.

Regulatory aspect: Before any clinical trial can begin, sponsors typically must compile preclinical data in a regulatory submission (for instance IND in the United States or a clinical trial authorization in the EU). Data requirements may cover toxicology, genotoxicity, safety pharmacology, and dose extrapolation.

The transition to human testing usually requires adherence to Good Laboratory Practice (GLP) in nonclinical toxicology studies and once moving to production, to Good Manufacturing Practice (GMP) standards for materials.

Methods and models include cell cultures, rodent and non‑rodent species, and newer approaches such as organoids and microphysiological systems. The goal is to improve relevance to humans and reduce reliance on animal testing where possible.

Challenges include translational gaps between animal models and human biology, high costs and long timelines, and ethical considerations.

In Norwegian usage, preklinikk is commonly used in pharmacology, biotechnology, and medicine to describe this early research phase, distinct from clinical trials (kliniske studier) conducted in humans.