Preclinical studies

Preclinical studies are a stage of research that precedes clinical trials (or therapy) and 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 tests.

Overview

Preclinical studies, also known as nonclinical studies, provide a general idea about the nature of the product and its safety efficacy. These studies are conducted in in vitro studies and in vivo animal testing. The data collected from these studies are used to decide whether the product should be tested in humans.

Types of Preclinical Studies

There are two main types of preclinical studies: Pharmacodynamics and Pharmacokinetics.

Pharmacodynamics

Pharmacodynamics studies the effects of a drug on a living organism. It involves the study of the biochemical and physiological effects of drugs and their mechanisms of action.

Pharmacokinetics

Pharmacokinetics studies the movement of drugs within the body. It involves the study of the absorption, distribution, metabolism, and excretion of drugs.

Regulatory Aspects

Preclinical studies are required before clinical trials can be conducted and they form an essential part of the data necessary for Investigational New Drug (IND) applications to regulatory authorities such as the Food and Drug Administration (FDA).

Ethical Considerations

The use of animals in preclinical studies raises ethical considerations. The Three Rs (Replacement, Reduction and Refinement) are guiding principles for the ethical use of animals in testing.

See Also

• Clinical trials
• Pharmacodynamics
• Pharmacokinetics
• Investigational New Drug
• Food and Drug Administration