Regulatory opportunities to encourage technology solutions to antibacterial drug resistance

Autor: Michael J. Dawson, Martin J. Blaser, David Findlay, Neil Fishman, Stuart Levy, Sarah Garner, Rick Davies, Tony White, Marcus Keogh-Brown, Ian Chopra, Lloyd Czaplewski, John H. Powers, Steven J. Projan, Richard Wise, Roger Finch, Dominique Monnet, Ragnar Norrby, Laura J. V. Piddock, Kieran Hand, Robert Guidos, Chantal M. Morel, David M. Livermore, Frances Burke, Gail Cassell, Richard Bax, Otto Carrs, Glenn Tillotson
Rok vydání: 2011
Předmět:
Zdroj: Journal of Antimicrobial Chemotherapy. 66:1945-1947
ISSN: 1460-2091
0305-7453
Popis: 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.
Databáze: OpenAIRE