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Early clinical drug development.

08:00 EDT 1st June 2019 | BioPortfolio

Summary of "Early clinical drug development."

The first administrations of a molecule to humans, so-called phase I studies of drug development, follow experimental animal studies which allow to have a first assessment of the pharmacological effects and toxicity of the molecule under development. Typically, these studies are performed in "healthy" subjects or in relapsing patients with cancer. Participants' safety is a priority. Trained professionals administer single doses, followed by repeated doses, in authorized medical centres. They allow to study the pharmacokinetic and pharmacodynamic profile of tested molecules in humans and to explore some sources of variability of these parameters. These studies are highly regulated and their methodology is fairly standardized.

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Journal Details

This article was published in the following journal.

Name: La Revue du praticien
ISSN: 2101-017X
Pages: 607-611

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