Preclinical studies can also be defined as basic research. This type of research takes place only in the laboratory and is not yet tested on humans. During the so-called preclinical development program, the drug candidate is examined for potential harmful effects. These primarily look at whether the substance has a toxic effect, triggers other diseases or even alters the genetic makeup of a living being. Preclinical studies must follow strict rules and procedures. Therefore, in addition to pharmacological and toxicity studies, pharmacokinetic and toxicokinetic studies must also be performed. Depending on the drug and the field of application, additional studies may be required.
If a study drug has successfully passed all the necessary preliminary studies, it may be tested on humans. The experiments first take place in cell cultures and then in animals. To ensure safety for humans, international guidelines must also be followed and adhered to.