Preclinico

Preclinico, or preclinical, refers to the stage of biomedical research and product development that occurs before testing in humans. In drug development, this phase includes laboratory experiments and animal studies designed to characterize safety, pharmacology, and toxicology, as well as the pharmacokinetic and pharmacodynamic properties of a candidate compound. The aim is to establish preliminary evidence of efficacy and to define safe starting doses for first‑in‑human trials, while identifying potential risks.

Key activities include in vitro assays, cell-based models, and in vivo studies in one or more animal species. Scientists investigate absorption, distribution, metabolism, and excretion (ADME), mechanism of action, dose–response relationships, and potential toxicities across organ systems. Toxicology, safety pharmacology, reproductive and developmental toxicity, and carcinogenicity studies are typically conducted under Good Laboratory Practice (GLP). Computational modelling and other non-animal approaches may supplement experimental work.

Regulatory context: data from preclinical studies are used to support an Investigational New Drug (IND) application or equivalent regulatory submission, enabling progression to clinical trials. Guidelines from bodies such as ICH describe the standards for pharmacology, toxicology, and quality control, while ethics and animal welfare principles, including the 3Rs (replacement, reduction, refinement), guide study design.

In Spanish and Portuguese, preclínico is commonly used to denote this stage, as well as the broader concept of the academic preclinical phase in education. Across contexts, preclinical work seeks to balance scientific insight with safety and regulatory expectations before human exposure.