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# Antibody-Drug Conjugate Guidance
- URL: https://www.fdaweb.com/antibody-drug-conjugate-guidance/
- Published: 2024-02-29T12:00:00.000Z
- Updated: 2026-09-14T14:24:15.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5156453

FDA has published a guidance, *Clinical Pharmacology Considerations for Antibody-Drug Conjugates*, with recommendations to assist industry and other parties involved in the development of antibody-drug conjugates (ADC) with a cytotoxic small-molecule drug or payload. The [document](https://www.fda.gov/media/155997/download?ref=fdaweb.com) addresses the agency’s current thinking about clinical pharmacology considerations and recommendations for bioanalytical methods, dosing strategies, dose- and exposure-response analysis, intrinsic factors, QTc assessments, immunogenicity, and drug-drug interactions.

The guidance does not focus on the development of any particular ADC, FDA says, and questions about regulatory recommendations for a particular ADC should be addressed to the appropriate agency review division.