präklinik

Präklinik refers to the phase of medical research and development that occurs before human clinical trials. This stage is crucial for evaluating the safety and efficacy of a new drug, medical device, or treatment in a laboratory or controlled setting. The primary goal of präklinik is to gather sufficient data to justify moving forward with testing in humans.

This preclinical phase typically involves a series of studies. In vitro studies utilize cells or tissues outside of a living organism to assess biological activity and potential toxicity. In vivo studies, on the other hand, involve animal models to understand how a substance or device behaves within a complex biological system. These animal studies can explore pharmacokinetics (absorption, distribution, metabolism, and excretion), pharmacodynamics (the drug's effect on the body), and potential side effects.

The data generated during präklinik is meticulously reviewed by regulatory agencies like the Food and Drug Administration (FDA) in the United States or the European Medicines Agency (EMA) in Europe. If the preclinical results demonstrate a favorable risk-benefit profile and suggest that the intervention is likely to be safe and effective in humans, researchers can then apply to begin clinical trials. Without successful präklinik, the development of new medical advancements would be significantly hindered.