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Quadruple-Checkerboard: A Modification of the Three-Dimensional Checkerboard for Studying Drug Combinations
Published on: July 24, 2021
Antibacterial drug development: challenges, recent developments, and future considerations
S Nambiar1, K Laessig1, J Toerner2
1Division of Anti-Infective Products, US Food and Drug Administration, Silver Spring, Maryland, USA.
Abstract:
A decline in antibacterial drug development coupled with emerging bacterial resistance has resulted in limited treatment options. One of the challenges facing antibacterial drug development is appropriate clinical trial designs. Noninferiority trials are appropriate to study new antibacterial drugs for the treatment of serious diseases; superiority trials can be challenging and cannot be the only acceptable trial design to study antibacterial drugs. Our efforts must continue to make new therapies available to meet patient needs.
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