Preclinical evaluation is a key part of the development process for new drugs and therapies. In this article, we will discuss the preclinical evaluation process in detail.
Design and synthesis of drug candidates
Preclinical evaluation begins with the design and synthesis phase of drug candidates. In this phase, scientists create possible drug molecules that can act on a specific biological target, like an enzyme or receptor.
In vitro studies
After drug candidates are synthesized, the first in vitro studies are conducted. In this phase, scientists take cells or tissues (human or animal) and expose them to drug candidates to see how they react. These studies can provide information on the safety, efficacy, pharmacodynamics and pharmacokinetics of the drug candidates.
Animal testing
If in vitro studies provide promising results, the animal testing stage follows. These studies can provide additional information on the safety and efficacy of the drug, as well as on its effects in living organisms.
Requesting authorization for clinical trials
If in vitro and animal studies provide promising results, the next step is to submit an application for clinical trial authorization to the relevant regulatory authorities, such as the Food and Drug Administration (FDA) in the United States or the European Medicines Agency (EMA) in the European Union. This application must include the full results of the preclinical evaluation, including data on efficacy, safety, pharmacodynamics and pharmacokinetics.
Summary
Preclinical evaluation is a key step in the development process of new drugs, which includes the design and synthesis of drug candidates, in vitro studies, animal studies, and application for clinical trial authorization. Despite its complexity, it is essential to ensure that a new drug is safe and potentially effective before it enters human clinical trials.
