GEORGE ARCIERI, M.D.
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 diagnoses before treatment.
ARCIERI G. Process of Developing a New Antimicrobial Drug. Ann Intern Med. 1978;89:838–841. doi: https://doi.org/10.7326/0003-4819-89-5-838
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Published: Ann Intern Med. 1978;89(5_Part_2):838-841.
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