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VI. Public Policy |

Process of Developing a New Antimicrobial Drug

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▸Requests for reprints should be addressed to George Arcieri, M.D.; Antibiotic Clinical Research, Schering Corporation, 60 Orange Street; Bloomfield, NJ 07003.

Bloomfield, New Jersey

© 1978 American College of PhysiciansAmerican College of Physicians

Ann Intern Med. 1978;89(5_Part_2):838-841. doi:10.7326/0003-4819-89-5-838
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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.





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