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USFDA Guidance: Submitting Clinical Trial Datasets to Evaluate the Impact of Immunogenicity on the Pharmacokinetics of a Drug
Immunogenicity is an important consideration in the development and regulatory evaluation of many biological products and therapeutic proteins. The formation of anti-drug antibodies (ADAs) can influence a drug's pharmacokinetic profile, potentially affecting drug exposure, efficacy, and safety. To support consistent regulatory assessment, the FDA issued the guidance "Submitting Clinical Trial Datasets to Evaluate the Impact of Immunogenicity on the Pharmacokinetics of a Drug.
Sharan Murugan
1 day ago3 min read