Process of developing a new antimicrobial drug.

G Arcieri

doi:10.7326/0003-4819-89-5-838

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Process of developing a new antimicrobial drug.

G Arcieri

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Abstract

The network for development of a new antimicrobial drug, from discovery of the compound to submission of the New Drug Application, is reviewed. The key problems encountered during this process, as elucidated through a survey of 62 American pharmaceutical companies, include difficulties in discovering new and significant antimicrobial drugs, the unpredictability of in-vitro and animal studies, lack of specific criteria for the bacteriologic response to therapy, difficulties in setting up well-controlled clinical studies, and difficulty with the timely enrollment of suitable patients with precise microbiologic diagnosis before treatment.

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Animals Anti-Bacterial Agents Clinical Trials as Topic Drug Evaluation Drug Evaluation, Preclinical Drug Industry Humans Research United States United States Food and Drug Administration Clinical Trial Journal Article

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G Arcieri. 1978. Process of developing a new antimicrobial drug.. https://doi.org/10.7326/0003-4819-89-5-838

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