Translational PK/PD for the Development of Novel Antibiotics-A Drug Developer's Perspective

• Main Authors: Caterina Bissantz (Author), Claudia Zampaloni (Author), Pascale David-Pierson (Author), Guennaelle Dieppois (Author), Andreas Guenther (Author), Andrej Trauner (Author), Lotte Winther (Author), William Stubbings (Author)
• Format: Book
• Published: MDPI AG, 2024-01-01T00:00:00Z.
• Subjects: article
• Online Access: Connect to this object online.

Antibiotic development traditionally involved large Phase 3 programs, preceded by Phase 2 studies. Recognizing the high unmet medical need for new antibiotics and, in some cases, challenges to conducting large clinical trials, regulators created a streamlined clinical development pathway in which a...