Preclinical development

Preclinical development refers to the stage of research that takes place before a drug is tested on humans. This phase involves laboratory experiments, testing on animals and applications for regulatory status.

Overview

Preclinical development is a crucial phase in the drug development process. It involves a series of tests and evaluations to determine the safety and efficacy of a new drug before it is tested on humans. This phase is designed to minimize the risks associated with new drugs and to ensure that they have the potential to provide significant health benefits.

Process

The process of preclinical development involves several steps. First, the drug is tested in the laboratory to determine its potential effects on the body. This includes tests to determine the drug's pharmacodynamics (how the drug affects the body) and pharmacokinetics (how the body processes the drug).

Next, the drug is tested on animals to evaluate its safety and efficacy. This is known as in vivo testing. The results of these tests are used to predict how the drug might behave in humans.

Finally, the data from these tests is used to apply for Investigational New Drug (IND) status from regulatory authorities such as the Food and Drug Administration (FDA) in the United States. If granted, the drug can proceed to clinical trials.

Challenges

Preclinical development is a complex and challenging process. It requires a deep understanding of biology, chemistry, and pharmacology, as well as strict adherence to regulatory guidelines. Furthermore, the results of preclinical testing do not always accurately predict the effects of a drug in humans, which can lead to failures in later stages of development.

See also

• Drug development
• Clinical trials
• Pharmacodynamics
• Pharmacokinetics
• Investigational New Drug

Preclinical development Resources
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