preklinika

Preklinika, a term commonly used in Czech and Slovak contexts, refers to the stage of drug development that proceeds before testing in humans. It comprises nonclinical studies focused on understanding a compound’s pharmacology, safety, and potential efficacy, as well as establishing whether it is suitable for human trials.

The work of preclinical development includes several components. In vitro studies examine biochemical and cellular effects to identify potential mechanisms of action and therapeutic targets. In vivo studies assess pharmacokinetics and biodistribution, as well as safety in one or more animal species. Safety pharmacology evaluates potential adverse effects on vital organ systems, while toxicology studies address acute, subchronic, and chronic toxicity, along with specific assessments of genotoxicity, carcinogenicity, and reproductive toxicity. A key output is the determination of dose–response relationships and safety margins, including concepts such as the NOAEL (no observed adverse effect level). This information helps define a starting dose and escalation plan for first-in-human trials.

Regulatory aspects are central to preclinical work. Studies are typically conducted under Good Laboratory Practice (GLP) standards, and the resulting data are assembled into a nonclinical package submitted to regulatory authorities to obtain permission to begin clinical trials (the specifics vary by country and regulatory body).

Limitations and scope are important to note. Preclinical studies cannot fully predict human outcomes; they inform risk management but do not guarantee safety. Increasingly, they are complemented by alternative methods such as in silico modeling and in vitro techniques, with ongoing emphasis on reducing animal testing in line with the 3Rs principle.