Antimicrobial Drug Resistance, Regulation, and Research1

Details

• Alternative Title:
  Emerg Infect Dis
• Personal Author:
  Metlay, Joshua P. ; Powers, John H. ; Dudley, Michael N. ; Christiansen, Keryn ; Finch, Roger G.
• Corporate Authors:
  on behalf of the Second Colloquium of the International Forum on Antibiotic Resistance
• Description:
  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.
• Subjects:
  • Perspective
  • Antibiotic resistance
  • Bacterial infections
  • Clinical trials
  • Drug approval
  • Drug industry
  • Drug resistance, microbial
  • Outcome assessment
  • Pharmacology
  • Pharmacokinetics
  More +
• Source:
  Emerg Infect Dis. 12(2):183-190.
• Document Type:
  Journal Article
• Volume:
  12
• Issue:
  2
• Download URL:
  https://stacks.cdc.gov/view/cdc/15824/cdc_15824_DS1.pdf
• File Type:
  [PDF - 258.75 KB]
• Collection(s):
  Emerging Infectious Diseases
• Main Document Checksum:
  urn:sha256:16daa631023a198ee0ebdb4e2ea5071663cecf8ba7a629b3a95a4f65fc008b9b