prekliniczny

Prekliniczny refers to the stage of research and development that occurs before human clinical trials begin. This phase is crucial for evaluating the safety and efficacy of a potential new drug, medical device, or treatment. Prekliniczny research is typically conducted in laboratory settings using cell cultures, animal models, or other experimental systems.

The primary goals of preclinical studies are to gather data on how a substance or device interacts with biological systems, to determine appropriate dosage ranges, to identify potential toxicities, and to establish proof of concept for its therapeutic potential. This involves a variety of tests, including in vitro (in glass or test tube) experiments and in vivo (in a living organism) studies. Pharmacokinetic and pharmacodynamic studies are often conducted to understand how the body absorbs, distributes, metabolizes, and excretes the substance, as well as its effects on the body.

Successful completion of preclinical testing is a prerequisite for seeking approval from regulatory authorities, such as the Food and Drug Administration (FDA) in the United States, to initiate human clinical trials. These earlier stages are vital for minimizing risks to human participants and for increasing the likelihood of developing safe and effective medical interventions. The data generated during the preclinical phase informs the design and protocols of subsequent clinical studies.