Submitting Clinical Trial Datasets to Evaluate the Impact of Immunogenicity on the Pharmacokinetics of a Drug

FDA (CDER)

GUIDANCE FINAL

Published: 6/18/2026Detected: 6/18/2026

Clarifies how to submit clinical trial datasets that allow FDA to evaluate whether immunogenicity affects a drug’s pharmacokinetics.

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#immunogenicity

#pharmacokinetics

#clinical trial datasets

#data submission

#analysis-ready datasets

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