præklinisk

Præklinisk is a Danish term that translates to "preclinical" in English. It refers to the phase of drug development that occurs before a drug is tested on humans. This phase is crucial in the process of bringing a new drug to market, as it helps to determine the safety, efficacy, and optimal dosage of the drug.

The preclinical phase typically involves several stages. Initially, the drug's potential is assessed in vitro, meaning in test tubes or cell cultures, to understand its basic mechanisms of action. This is followed by in vivo studies, where the drug is tested in animals to evaluate its pharmacokinetics, pharmacodynamics, and toxicity.

Key objectives of the preclinical phase include:

1. Establishing the drug's mechanism of action.

2. Determining the drug's pharmacokinetics, such as absorption, distribution, metabolism, and excretion.

3. Assessing the drug's safety profile, including potential side effects and toxicity.

4. Identifying the optimal dosage and route of administration.

If a drug successfully passes the preclinical phase, it proceeds to clinical trials, where it is tested on human volunteers to further evaluate its safety and efficacy. The preclinical phase is essential for reducing the risk of failure in later stages of drug development and for ensuring that only safe and effective drugs advance to human testing.