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J. Antimicrob. Chemother. · Sep 2011
Regulatory opportunities to encourage technology solutions to antibacterial drug resistance.
- Roger Finch and BSAC Working Party on The Urgent Need: Regenerating Antibacterial Drug Discovery and Development.
- Nottingham University Hospitals, Department of Microbiology and Infectious Diseases, The Clinical Sciences Building, Hucknall Road, Nottingham NG51PB, UK. roger.finch@nottingham.ac.uk
- J. Antimicrob. Chemother. 2011 Sep 1; 66 (9): 1945-7.
AbstractRegulatory 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.
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