Antimicrobial drug resistance, regulation, and research.
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.
VA Medical Center, University of Pennsylvania School of Medicine, Center for Clinical Epidemiology and Biostatistics, Philadelphia, Pennsylvania 19104, USA. jmetlay@cceb.med.upenn.edu
Joshua P
JP
Metlay
John H
JH
Powers
Michael N
MN
Dudley
Keryn
K
Christiansen
Roger G
RG
Finch
D000900:Anti-Bacterial Agents / Q000493:pharmacokinetics / Q000494:pharmacology / Q000627:therapeutic use; D001419:Bacteria / Q000187:drug effects; D001424:Bacterial Infections / Q000188:drug therapy / Q000382:microbiology; D015195:Drug Design; D024881:Drug Resistance, Bacterial; D006801:Humans; D007391:International Cooperation; D007880:Legislation, Drug; D012106:Research
D000900:Anti-Bacterial Agents