Abstract:
:Innovative regulatory and legislative measures to stimulate and facilitate the development of new antimicrobial drugs are needed. We discuss research approaches that can aid regulatory decision making on the treatment of resistant infections and minimization of resistance selection. We also outline current and future measures that regulatory agencies may employ to help control resistance and promote drug development. Pharmacokinetic/pharmacodynamic research models offer promising approaches to define the determinants of resistance selection and drug doses that optimize efficacy and reduce resistance selection. Internationally, variations exist in how regulators use drug scheduling, subsidy restrictions, central directives, educational guidelines, amendments to prescribing information, and indication review. Recent consultations and collaborations between regulators, academics, and industry are welcome. Efforts to coordinate regulatory measures would benefit from greater levels of international dialogue.
journal_name
Emerg Infect Disjournal_title
Emerging infectious diseasesauthors
Metlay JP,Powers JH,Dudley MN,Christiansen K,Finch RGdoi
10.3201/eid1202.050078subject
Has Abstractpub_date
2006-02-01 00:00:00pages
183-90issue
2eissn
1080-6040issn
1080-6059journal_volume
12pub_type
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