Esiklinisistä

Esiklinisistä refers to the stage of research and development that occurs before a new drug or medical treatment is tested in humans. This preclinical phase is crucial for evaluating the safety and potential efficacy of a candidate therapy. It typically involves a series of laboratory and animal studies.

In vitro studies, or those conducted in test tubes or petri dishes, are often the first step. These experiments assess how the substance interacts with cells, tissues, or biological molecules. They can provide initial insights into the drug's mechanism of action and its potential toxicity at a cellular level. Following in vitro testing, in vivo studies are performed, usually involving animal models. These studies aim to understand how the drug is absorbed, distributed, metabolized, and excreted by a living organism (pharmacokinetics) and what effects it has on the body (pharmacodynamics). Animal studies are also designed to identify potential side effects and determine safe dosage ranges.

The data gathered during the preclinical phase is essential for regulatory agencies, such as the Food and Drug Administration (FDA) in the United States, to determine whether a drug is safe enough to proceed to human clinical trials. If the preclinical studies demonstrate acceptable safety and promising efficacy, the researchers can then submit an Investigational New Drug (IND) application to begin testing in humans. The preclinical stage is a vital gatekeeper, ensuring that only therapies with a reasonable chance of success and an acceptable safety profile advance to the next, more complex and expensive, stages of drug development.