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# Guide on Immunogenicity Data Submissions for Pharmacokinetic Reviews
- URL: https://www.fdaweb.com/guide-on-immunogenicity-data-submissions-for-pharmacokinetic-reviews/
- Published: 2026-06-18T12:00:00.000Z
- Updated: 2026-09-14T13:41:24.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5161331

FDA has issued a guidance that is intended to assist industry in the submission of datasets from clinical studies that evaluate immunogenicity and its impact on the pharmacokinetics of a drug. It provides detailed information and specifications for these datasets. “These specifications may elicit discussions between the sponsor and reviewers regarding issues with trial design or conduct that may affect the content of the analysis datasets,” the document says.

The [guidance](https://www.fda.gov/media/193208/download?ref=fdaweb.com), titled *Submitting Clinical Trial Datasets to Evaluate the Impact of Immunogenicity on the Pharmacokinetics of a Drug*, provides detailed data specifications for the following datasets:

- Analysis Dataset for Immunogenicity Specimen
- Analysis Dataset for Pharmacokinetic Concentrations
- Subject-Level Analysis Dataset