Preclinical evaluation is an essential step in the process of developing new drugs. In this article, we will discuss the role of preclinical evaluation in new drug development.
Preliminary evaluation of new drug candidates
The first step in preclinical evaluation is the identification of potential drug candidates and their initial evaluation. At this stage, researchers perform a series of in vitro and in silico (using computers) tests to assess whether potential drugs show promise in terms of efficacy and safety.
In vitro studies
After the initial evaluation, drug candidates are subjected to a series of in vitro tests. These tests allow scientists to assess how substances interact with their biological targets, how they are metabolized by the body, their potential side effects, and how they may affect various biological processes.
In vivo studies
If the results of in vitro studies are promising, the next step is in vivo studies, usually conducted on animals. These studies help assess how the drug works throughout the body, how it is absorbed, distributed, metabolized and excreted, as well as its potential side effects and effectiveness.
Application for approval of clinical trials
If the results of the preclinical evaluation are promising, researchers can submit an application for human clinical trial authorization to the relevant regulatory authorities. This application must include details of the preclinical evaluation, including the results of in vitro and in vivo studies.
Impact of preclinical evaluation on new drug development
Preclinical evaluation has a key impact on the development of new drugs. The results of preclinical evaluation can influence decisions about which drug candidates are further developed, what doses are safe and effective, and the planning and design of clinical trials. In addition, success in preclinical evaluation is one of the key factors that can attract investors and funding for further drug development.
Summary
Preclinical evaluation is crucial to the process of new drug development, providing important data that can influence decisions on safety, efficacy, dosing and clinical trial design. It is a complex process that requires a multidisciplinary approach and careful coordination, but its importance to the development of safe and effective drugs is undeniable.
