Business · 01/03/2024
FDA Releases Final Guidance on Clinical Pharmacology Considerations for Antibody-Drug Conjugates
The US Food and Drug Administration (FDA) has released a final guidance document titled 'Clinical Pharmacology Considerations for Antibody-Drug Conjugates,' which provides recommendations for the development of antibody-drug conjugates (ADCs), addressing key areas such as bioanalytical methods, dose selection, and drug-drug interactions.
Original source language: Federal Register — Food and Drug AdministrationOpen original release →