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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.
Frequently asked queries:
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What are the Regulatory Requirements for Toxicology in Drug Development?
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