TY - JOUR AU - Metlay, Joshua AU - Powers, John AU - Dudley, Michael AU - Christiansen, Keryn AU - Finch, Roger T1 - Antimicrobial Drug Resistance, Regulation, and Research T2 - Emerging Infectious Disease journal PY - 2006 VL - 12 IS - 2 SP - 183 SN - 1080-6059 AB - 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. KW - Antibiotic resistance KW - Bacterial infections KW - Clinical trials KW - Drug approval KW - Drug industry KW - Drug resistance, microbial KW - Outcome assessment KW - Pharmacology KW - Pharmacokinetics DO - 10.3201/eid1202.050078 UR - https://wwwnc.cdc.gov/eid/article/12/2/05-0078_article ER - End of Reference