# Submitting Clinical Trial Datasets to Evaluate the Impact of Immunogenicity on the Pharmacokinetics of a Drug - FDA Guidance Document

Source: https://www.keypedia.com/guidances/guidance-document/submitting-clinical-trial-datasets-to-evaluate-the-impact-of-immunogenicity-on-the-pharmacokinetics-of-a-drug/b906dd96-5571-4f8d-81c0-ac787e48c230

> FDA guidance document: Submitting Clinical Trial Datasets to Evaluate the Impact of Immunogenicity on the Pharmacokinetics of a Drug. Issue date: June 18, 2026. Get complete insights and analysis.

---

## Details

- Title: Submitting Clinical Trial Datasets to Evaluate the Impact of Immunogenicity on the Pharmacokinetics of a Drug
- Communication Type: Guidance Document
- Product Type: drugs
- Office Name: Center for Drug Evaluation and Research
- Office URL: /offices/center-for-drug-evaluation-and-research/cd980d74-1cbf-4226-ba9a-9045324c236c
- Issue Date: 2026-06-18
- Last Changed: 2026-06-18
- Docket Number: <a href="https://www.regulations.gov/docket/FDA-2017-D-6821">FDA-2017-D-6821</a>

## Related Documents

- [Technical Specifications for Submitting Clinical Trial Data Sets for Response Assessments for Treatments of Acute Leukemias:  Guidance for Industry Technical Specifications Document](https://www.keypedia.com/guidances/guidance-document/technical-specifications-for-submitting-clinical-trial-data-sets-for-response-assessments-for-treatments-of-acute-leukemias-guidance-for-industry-technical-specifications-document/fcae5d52-07e3-4b70-a7d3-d72bbe4ba316)
- [Submitting Nonclinical Datasets for Evaluation of Rodent Carcinogenicity Studies of Pharmaceuticals](https://www.keypedia.com/guidances/guidance-document/submitting-nonclinical-datasets-for-evaluation-of-rodent-carcinogenicity-studies-of-pharmaceuticals/5558f50a-6637-45c7-9848-23f5e55738d6)
- [Submitting Next Generation Sequencing Data to the Division of Antiviral Products Guidance for Industry Technical Specifications Document](https://www.keypedia.com/guidances/guidance-document/submitting-next-generation-sequencing-data-to-the-division-of-antiviral-products-guidance-for-industry-technical-specifications-document/4edd1e8a-43c4-4293-b6b8-ac9472e1a619)