préclínicos

Préclínicos refers to studies conducted on non-human subjects, typically in laboratory settings, prior to testing a new drug, medical device, or treatment in humans. These studies are a crucial step in the research and development process for new therapies. The primary goal of préclínicos is to assess the safety and efficacy of a substance or intervention in a biological system.

These studies are often divided into two main categories: in vitro and in vivo. In vitro studies involve experiments conducted in controlled laboratory environments, such as on cells or tissues in test tubes or petri dishes. This allows researchers to investigate specific biological mechanisms and cellular responses without the complexities of a whole organism. In vivo studies, on the other hand, are conducted on living organisms, most commonly laboratory animals like rodents, rabbits, or primates. These studies are designed to evaluate how a substance is absorbed, distributed, metabolized, and excreted by the body (pharmacokinetics), as well as its effects on physiological systems and potential toxicity.

The data generated from préclínicos studies is essential for determining whether an intervention is sufficiently safe and shows promise for potential therapeutic benefit to warrant progression to human clinical trials. Regulatory agencies, such as the Food and Drug Administration (FDA) in the United States, require extensive préclínicos data before approving human testing. This rigorous evaluation helps to minimize risks to human participants and ensures that only the most promising candidates advance through the drug development pipeline.