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

Issue Date: June 18, 2026
Issued by: Center for Drug Evaluation and Research
Topic(s): Clinical – Pharmacology
Status: Final

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

This technical specifications document represents the Food and Drug Administration’s (FDA’s) current thinking on this topic. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. You can use an alternative approach if the approach satisfies the requirements of the applicable statutes and regulations. If you want to discuss an alternative approach, contact the FDA staff responsible for implementing this guidance. If you cannot identify the appropriate FDA staff, send an email to cder-edata@fda.hhs.gov or cber.cdisc@fda.hhs.gov.

Download the Guidance Document