Antimicrobial Drug Resistance, Regulation, and Research1

Metlay, Joshua P.; Powers, John H.; Dudley, Michael N.; Christiansen, Keryn; Finch, Roger G.

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Antimicrobial Drug Resistance, Regulation, and Research1

Supporting Files Public Domain

Feb 2006
By Metlay, Joshua P. ; Powers, John H. ; Dudley, Michael N. ; ...

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:

Anti-Bacterial Agents Antibiotic Resistance Bacteria Bacterial Infections Clinical Trials Drug Approval Drug Design Drug Industry Drug Resistance, Bacterial Drug Resistance, Microbial Humans International Cooperation Legislation, Drug Outcome Assessment Perspective Pharmacokinetics Pharmacology Research
Source:

Emerg Infect Dis. 12(2):183-190.
Document Type:

Journal Article
Volume:

12
Issue:

2
Collection(s):

Emerging Infectious Diseases
Main Document Checksum:

urn:sha256:16daa631023a198ee0ebdb4e2ea5071663cecf8ba7a629b3a95a4f65fc008b9b
Download URL:

https://stacks.cdc.gov/view/cdc/15824/cdc_15824_DS1.pdf
File Type:

[PDF - 258.75 KB ]

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