Preclinical research

Preclinical research also known as preclinical study or nonclinical study refers to laboratory experiments conducted on cells, animals and animal models before they are performed on humans. This type of research is designed to assess the safety and effectiveness of new pharmaceutical drugs, medical devices, and treatment methods.

Overview

Preclinical research is a critical stage in the drug development process. It involves in vitro (test tube or cell culture) and in vivo (animal) testing to determine whether a drug is safe and effective for human use. The main goal of preclinical research is to ensure that potential new treatments are safe enough to proceed to clinical trials.

Types of Preclinical Research

There are two main types of preclinical research: in vitro and in vivo studies.

In Vitro Studies

In vitro studies are performed with cells or biological molecules outside their normal biological context. These studies are often used to study the interaction between a molecule and a drug.

In Vivo Studies

In vivo studies are performed on whole, living organisms. In preclinical research, these organisms are typically laboratory animals such as mice or rats.

Regulatory Aspects

Preclinical research must comply with regulations set by the Food and Drug Administration (FDA) in the United States, or by similar regulatory bodies in other countries. These regulations ensure that the research is conducted ethically and that the results are reliable.

Challenges and Criticisms

Despite its importance, preclinical research has faced criticism for its use of animal testing, its cost, and the reliability of its results. Some critics argue that the results of animal testing may not accurately predict human responses.

See Also

• Clinical research
• Drug development
• Animal testing
• In vitro
• In vivo

References

Preclinical research Resources
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