Preclinical study

Preclinical study is a stage of research that precedes clinical trials (or therapy), during which important feasibility, iterative testing and drug safety data are collected. The main aim of preclinical studies is to determine a product's ultimate safety profile. Products may include medical devices, drugs, gene therapy solutions and diagnostic tools.

Overview

Preclinical studies, also called nonclinical studies, can provide the necessary background information about a device or drug's pharmacokinetic properties. These studies can also give detailed information about the pharmacologic effects of the drug and its potential toxicity.

Types of Preclinical Studies

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

In vitro studies, also known as test-tube experiments, are conducted using cells or biological molecules outside their normal biological context. These studies can provide valuable information about the potential effects of a drug or device.

In vivo studies, on the other hand, are conducted on whole, living organisms. These studies are typically conducted on animals such as mice or rats, and provide information about the effects of a drug or device in a living system.

Regulatory Guidelines

Preclinical studies are guided by regulatory guidelines provided by the Food and Drug Administration (FDA) in the United States, or by the European Medicines Agency (EMA) in the European Union. These guidelines provide a framework for ensuring that preclinical studies are conducted ethically and that the data generated is reliable.

See Also

• Clinical trial
• Pharmacokinetics
• Pharmacology
• Toxicology

References

Preclinical study Resources
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