Preclinical evaluation is a key step in the development process of new drugs, therapies or medical technologies. In this article, we will look at preclinical evaluation and its goals.
What is preclinical evaluation?
Preclinical evaluation is a stage of the research process conducted before human clinical trials. In this phase, researchers conduct a series of in vitro (e.g., in test tubes) and in vivo (e.g., in animals) studies to investigate the safety, efficacy, pharmacokinetics (how the body affects the drug) and pharmacodynamics (how the drug affects the body) of a new drug or therapy.
Objectives of preclinical evaluation
The main goal of preclinical evaluation is to ensure that a new drug or therapy is safe and potentially effective before it reaches humans. Below are some of the main objectives of preclinical evaluation.
Safety assessment
One of the most important goals of preclinical evaluation is to assess the safety of a new drug. This includes testing for potential side effects, toxicity, drug interactions and allergic reactions. These studies help determine safe doses for further human clinical trials.
Efficacy evaluation
Another important goal of preclinical evaluation is to assess the effectiveness of a new drug or therapy. This involves testing whether the drug effectively attacks the targeted disease mechanism and whether it provides the expected health benefits.
Pharmacokinetics and pharmacodynamics
Preclinical evaluation also includes testing the pharmacokinetics and pharmacodynamics of the new drug. Pharmacokinetic studies look at how the body affects the drug, covering the processes of absorption, distribution, metabolism and excretion. Pharmacodynamic studies, on the other hand, analyze how a drug affects the body, evaluating its effects at the molecular and cellular levels.
Summary
Preclinical evaluation is a key step in the development of new drugs and therapies. By assessing safety, efficacy, as well as studying pharmacokinetics and pharmacodynamics, preclinical evaluation helps ensure that new drugs are safe and potentially effective before they enter human clinical trials. In this context, preclinical evaluation is essential for advancing medicine and protecting patients' health.