Translational PK/PD for the Development of Novel Antibiotics—A Drug Developer’s Perspective

Translational PK/PD for the Development of Novel Antibiotics—A Drug Developer’s Perspective

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...

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Bibliographic Details
Main Authors: Caterina Bissantz, Claudia Zampaloni, Pascale David-Pierson, Guennaelle Dieppois, Andreas Guenther, Andrej Trauner, Lotte Winther, William Stubbings
Format: Article
Language:English
Published: MDPI AG 2024-01-01
Series:Antibiotics
Subjects:
antibiotics
drug development
regulatory
translational PK/PD
PK/PD index
PTA
Online Access:https://www.mdpi.com/2079-6382/13/1/72

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