Phase I clinical studies form an important foundation for drug development and eventual approval of life-saving therapies in man. Potential drug candidates are screened for entry into Phase I trials by extensive in-vitro testing and tolerance in several animal species. Early in-vitro testing establishes potential mechanisms of action, such as binding to a receptor or enzyme. Animal toxicology at large doses are used to determine a small, safe starting dose for first-in-human trials.
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