Regulatory requirements for clinical evaluation of antimicrobial agents
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Evaluation of antimicrobial agents in governed mainly by interaction between the pharmaceutical industry and regulatory authorities. The 1977 FDA guidelines have been setting the standards for more than a decade now. Basic principles of the 1977 guidelines remain valid, however changes in the definition of end-points of response, as measured by both clinical and microbiological criteria, have occurred. The new (draft) FDA guidelines and the 1989 guidelines of the British Society of Antimicrobial Chemotherapy are more consistent with contemporary concepts of treatment. In general, the differences in the requirements are minimal with a few exceptions, namely the requirements concerning blinding and assessment of clinical efficacy by site of infection and by organism in the FDA guidelines.
KeywordsInternal Medicine Basic Principle Clinical Evaluation Antimicrobial Agent Clinical Efficacy
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- 1.US Food andDrug Administration: Guidelines for the clinical evaluation of anti-infective drugs (systemic) (adults and children). Publication no. FDA 77-3046. US Department of Health, Education and Welfare, Washington, DC, 1977.Google Scholar
- 2.Gilbert DN, Beam TR, Kunin CM: The implications for Europe of revised FDA guidelines for clinical trials with anti-infective agents. European Journal of Clinical Microbiology and Infectious Diseases 1990, 9: 552–558.Google Scholar
- 3.Working Party of the British Society of Antimicrobial Chemotherapy: The clinical evaluation of antibacterial drugs. Journal of Antimicrobial Chemotherapy 1989, 23, Supplement B: 1–42.Google Scholar
- 4.World Health Organisation: Guidelines for the clinical investigation of antibacterial drugs. WHO Regional Office for Europe, Copenhagen, 1987.Google Scholar
- 5.Gardner MJ, Altman DG: Confidence intervals rather than p values: estimation rather than hypothesis testing. British Medical Journal 1986, 292: 746–750.Google Scholar