Literature DB >> 26093075

Use of old antibiotics now and in the future from a pharmacokinetic/pharmacodynamic perspective.

A E Muller1, U Theuretzbacher2, J W Mouton3.   

Abstract

Because of the increase in bacterial resistance to commonly used antibacterial drugs, old antibiotics are being 'revived' and, once again, are attracting interest. Many of these old antibiotics were approved long ago, in an era when there was no clear process for development, and requirements for efficacy to be demonstrated in rigorous clinical trials did not exist. At the time of these approvals, pharmacokinetic and pharmacodynamic principles were largely unknown, and did not inform the dose-finding process or recommendations for optimal usage. Indeed, the task of generating basic vital information for these old antibiotics remains to be performed. In this review, we provide a brief overview of the most essential data needed for dose justification and optimization. An overview of the shortage of data for selected old antibiotics illustrates the scope of the problem. In order to prevent harming patients with clinical decisions based on inadequate evidence, a redevelopment procedure for old antibiotics is urgently needed, including a regulatory framework.
Copyright © 2015 European Society of Clinical Microbiology and Infectious Diseases. Published by Elsevier Ltd. All rights reserved.

Entities:  

Keywords:  Dose optimization; PK/PD; effectiveness; registration; revived antibiotics

Mesh:

Substances:

Year:  2015        PMID: 26093075     DOI: 10.1016/j.cmi.2015.06.007

Source DB:  PubMed          Journal:  Clin Microbiol Infect        ISSN: 1198-743X            Impact factor:   8.067


  10 in total

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  10 in total

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