
pmid: 16494740
pmc: PMC3373116
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.
Bacteria, Antibiotic resistance, International Cooperation, Research, R, Drug industry, Infectious and parasitic diseases, RC109-216, Bacterial Infections, Legislation, Drug, Anti-Bacterial Agents, Clinical trials, Bacterial infections, Drug Design, Perspective, Drug Resistance, Bacterial, Drug approval, Medicine, Humans, Drug resistance, microbial
Bacteria, Antibiotic resistance, International Cooperation, Research, R, Drug industry, Infectious and parasitic diseases, RC109-216, Bacterial Infections, Legislation, Drug, Anti-Bacterial Agents, Clinical trials, Bacterial infections, Drug Design, Perspective, Drug Resistance, Bacterial, Drug approval, Medicine, Humans, Drug resistance, microbial
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| influence This indicator reflects the overall/total impact of an article in the research community at large, based on the underlying citation network (diachronically). | Top 10% | |
| impulse This indicator reflects the initial momentum of an article directly after its publication, based on the underlying citation network. | Top 10% |
