preclinics

Preclinics is a term that generally refers to the period of medical research and development that occurs before human clinical trials begin. This phase is crucial for assessing the safety and efficacy of a new drug, therapy, or medical device. It involves a range of studies conducted in laboratory settings and on animal models.

The primary goals of preclinical research are to gather sufficient data to support the rationale for human testing and to identify potential risks. This typically includes in vitro studies, which use cell cultures or isolated tissues, and in vivo studies, which involve living organisms, most commonly rodents. These investigations aim to understand how a substance is absorbed, distributed, metabolized, and excreted (pharmacokinetics) and its effects on the body (pharmacodynamics). Toxicology studies are a critical component, evaluating potential adverse effects, determining safe dosage ranges, and identifying target organs for toxicity.

Successful completion of preclinical studies provides the necessary evidence for regulatory agencies, such as the Food and Drug Administration (FDA) in the United States, to grant approval for initiating human clinical trials. This transition marks a significant milestone, moving a potential treatment from the laboratory to real-world patient populations. The rigor and thoroughness of preclinical research directly impact the safety and success of subsequent clinical development.