preklinikai

Preklinikai, or preclinical research, refers to the stage of medical research conducted before testing in humans. In Hungarian usage, the term denotes experiments and studies aimed at evaluating the safety, tolerability, pharmacology, and toxicology of a drug or medical intervention prior to clinical trials.

Typical preclinical activities include in vitro experiments using cell cultures, in vivo studies in animals, and in silico modeling to understand pharmacokinetics (how the body processes the substance) and pharmacodynamics (the substance's effects on the body). Toxicology testing assesses potential adverse effects, identifies safe starting doses, and defines exposure margins. Additional work covers formulation development, stability, and manufacturing feasibility.

Preclinical data, conducted under Good Laboratory Practice (GLP) standards and guided by regulatory frameworks, are used to support an Investigational New Drug (IND) application in the United States, or a Clinical Trial Application in the European Union. The goal is to establish a justification for first-in-human studies and to determine the initial dose range and safety monitoring requirements.

While preclinical results provide essential safety and activity signals, they do not always predict human outcomes, and many compounds fail during clinical testing. Ethical considerations include minimizing animal use and applying the 3Rs principle (Replacement, Reduction, Refinement).