Preclinical research refers to a series of experimental studies that are carried out before clinical trials on humans begin. They are the first stage in the development and evaluation of new medical technologies, active pharmaceutical ingredients, medical devices and treatments. The goal of preclinical studies is to assess the safety, toxicity and potential efficacy of the active pharmaceutical ingredient or procedure being studied.

The most important aspects of preclinical research (translation into German: präklinische Forschung) include:

• Laboratory tests: In this step, laboratory tests and experiments are carried out using cells, tissues or animals. The aim is to determine how the substance interacts with biological systems and what effects it could have on them.
• Toxicity studies: The toxicity of investigational new drugs (IND) is tested in preclinical studies. This includes assessing its effects on organs and tissues as well as determining a safe dosage.
• Pharmacokinetics and pharmacodynamics: Pharmacokinetic studies (German translation: pharmakokinetische Studien) examine how the body “processes” a substance (how it is absorbed, distributed, metabolized and excreted), while pharmacodynamics evaluates the substance’s effect and mechanism of action.
• Studies on the mechanism of action: Preclinical studies can be used to investigate the molecular and biological mechanisms by which the investigational new drug works.
• Safety assessment: Preclinical studies help to identify potential risks and adverse effects (German: unerwünschte Arzneimittelwirkungen) associated with the use of a product and to assess its drug safety.
• Development of protocols for clinical trials: The results of preclinical studies are often used to develop protocols for clinical trials conducted on human subjects.

Preclinical research usually precedes clinical trials and is intended to ensure that new active pharmaceutical ingredients and methods are safe and highly likely to be effective before they are tested on patients. This phase also helps to eliminate the most dangerous and unsafe treatment concepts before clinical trials even start.

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