Abstract
Regulatory agencies play a critical role in the licensing of new antimicrobial agents. To address the pivotal role played by regulatory agencies, particularly in the context of a paucity of new drugs active against bacteria resistant to currently available drugs, the BSAC formed the 'Urgent Need' Working Party to address the regeneration of antibacterial drug discovery and development. The Working Party identified a number of issues, including: increased application of pharmacokinetic/pharmacodynamic principles to expedite drug development; the need to prioritize licensing of drugs (including 'orphan' drugs) active in life-threatening infections; and expansion of the use of surrogate markers and rapid point of care diagnostics to facilitate drug development.
Original language | English |
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Pages (from-to) | 1945-7 |
Number of pages | 3 |
Journal | Journal of Antimicrobial Chemotherapy |
Volume | 66 |
Issue number | 9 |
DOIs | |
Publication status | Published - Sept 2011 |
Keywords
- Anti-Bacterial Agents
- Bacterial Infections
- Diffusion of Innovation
- Drug Design
- Drug Resistance, Bacterial
- Humans
- Legislation, Drug
- Microbiology
- Technology