Preclinical

Preclinical studies are experiments performed before they are conducted on humans. These studies involve in vitro (test tube or cell culture) and in vivo (animal) experiments using wide-ranging doses of the study drug to obtain preliminary efficacy, toxicity and pharmacokinetic information. This is a critical phase in drug development due to the high cost, time commitment, and risk involved later in the process.

Overview

Preclinical studies are designed to determine a product's ultimate safety profile. Products may include medical devices, drugs, gene therapy solutions and Diagnostic devices. These studies can provide valuable insights into a product's potential therapeutic value and safety risks.

Types of Preclinical Studies

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

In Vitro

In vitro studies, also known as test tube experiments, are performed with cells or biological molecules outside their normal biological context. These studies are conducted using components of an organism that have been isolated from their usual biological surroundings in order to permit a more detailed or more convenient analysis than can be done with whole organisms.

In Vivo

In vivo studies, on the other hand, are experiments that are conducted on whole, living organisms. Usually, these are animal models such as rats or mice. These studies are designed to be very controlled and are conducted in a laboratory setting.

Importance of Preclinical Studies

Preclinical studies are a critical component of drug development. They provide the data necessary for a Investigational New Drug (IND) application to the Food and Drug Administration (FDA). The FDA uses the data from these studies to decide whether a drug is safe for testing in humans during clinical trials.

See Also

• Clinical trial
• Drug development
• Food and Drug Administration
• Investigational New Drug

References

Preclinical Resources
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