Issue Date: March 1, 2024
Issued by: Center for Drug Evaluation and Research
Topic(s): Clinical – Pharmacology
Status: Final
Clinical Pharmacology Considerations for Antibody-Drug Conjugates Guidance for Industry: Guidance for Industry
This guidance provides recommendations to assist industry and other parties involved in the development of antibody-drug conjugates (ADCs) with a cytotoxic small-molecule drug or payload. Specifically, this guidance addresses the FDA’s current thinking regarding clinical pharmacology considerations and recommendations for bioanalytical methods, dosing strategies, dose- and exposure-response analysis, intrinsic factors, QTc assessments, immunogenicity, and drug-drug interactions (DDIs). The principles discussed in this guidance might not be applicable to the development of other types of ADCs (e.g., ADCs with payloads other than cytotoxic small molecule drugs and/or for indications other than oncology). Additional Guidance Resources Clinical Pharmacology Considerations for Antibody-Drug Conjugates: Guidance Snapshot Clinical Pharmacology Considerations for Antibody-Drug Conjugates: Podcast Clinical Pharmacology Considerations for Antibody-Drug Conjugates: Podcast Transcript
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