drug development

What are the Regulatory Requirements for Toxicology in Drug Development?

Regulatory agencies have stringent requirements for toxicological evaluations to ensure drug safety. These requirements often include:
Compliance with Good Laboratory Practice (GLP) standards.
Submission of comprehensive toxicological data in the form of an Investigational New Drug (IND) application.
Continued monitoring of drug safety through post-marketing surveillance, also known as pharmacovigilance.
Meeting these requirements is essential for gaining regulatory approval and ensuring public safety.

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