16.04.2024 - 18.04.2024Hilton Boston Back Bay, 40 Dalton Street, 02115 Boston, Massachusetts, USA
Time: 08:00 AM - 03:45 PM
Kongressthemen The updated ICH Q14 guidance from the FDA revising analytical procedures used for release and stability testing has shown higher product quality expectations from regulatory agencies. As analytical studies become an indispensable requirement to progress the antibody-drug conjugate space forward, so has the need for rigorous analytical methodologies that ensure product quality ahead of regulatory submissions.