Präklinischen

Präklinischen refers to the phase of research and development that occurs before human clinical trials. This stage is crucial for assessing the safety and efficacy of a potential new treatment, drug, or medical device. It involves a series of studies conducted in laboratory settings, often using cell cultures and animal models, to gather essential data.

The primary goals of präklinischen studies are to understand the pharmacological properties, including how a substance is absorbed, distributed, metabolized, and excreted by the body (pharmacokinetics), and its effects on biological systems (pharmacodynamics). Researchers also investigate potential toxicity, determine safe dosage ranges, and identify any adverse effects. These experiments provide the foundational evidence needed to justify proceeding to human testing.

In the context of drug development, präklinischen research typically includes in vitro studies and in vivo studies. In vitro studies are performed in controlled laboratory environments outside of a living organism, such as in test tubes or petri dishes. In vivo studies involve experiments conducted on living organisms, most commonly laboratory animals like rodents, rabbits, or non-human primates. The data generated during this phase is meticulously reviewed by regulatory agencies, such as the Food and Drug Administration (FDA) in the United States, before approval is granted for clinical trials in humans.