u.s. food and drug administration (fda)

What is the Importance of Toxicology in Drug Approval?

Toxicology is a cornerstone in the drug approval process. Before any new drug can be approved, it must undergo a thorough toxicological evaluation to ensure it does not pose undue risk to patients. The FDA requires comprehensive data on the drug's [pharmacokinetics](href), [pharmacodynamics](href), and any potential [toxic effects](href) observed during both preclinical and clinical testing. This helps in determining the appropriate dosage, identifying potential side effects, and ensuring overall patient safety.

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