Use of Preclinical Data for Selection of a Phase II/III Dose for Evernimicin and Identification of a Preclinical MIC Breakpoint

One of the most challenging issues in the design of phase II/III clinical trials of antimicrobial agents is dose selection. The choice is often based on preclinical data from pharmacokinetic (PK) studies with animals and healthy volunteers but is rarely linked directly to the target organisms except...

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Detalles Bibliográficos
Main Authors: Drusano, G. L., Preston, S. L., Hardalo, C., Hare, R., Banfield, C., Andes, D., Vesga, O., Craig, W. A.
Formato: Artigo
Idioma:Inglês
Publicado: American Society for Microbiology 2001
Assuntos:
Experimental Therapeutics
Acceso en liña:https://ncbi.nlm.nih.gov/pmc/articles/PMC90233/
https://ncbi.nlm.nih.gov/pubmed/11120938
https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1128/AAC.45.1.13-22.2001
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