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Evaluation of safety and tolerance in clinical trials with antimicrobial agents

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Abstract

In this review the general and specific difficulties encountered in the evaluation of safety and tolerance of antimicrobial agents in clinical trials are discussed. In addition to the usual pharmacological and toxicological effects (adverse drug reactions) occurring in individual patients, microbiologically induced side-effects also have to be considered. The different methods for registration of side-effects and their limitations are discussed. A system is proposed for evaluation of the cause/effect relationships of adverse drug reactions. A system is also discussed for the evaluation of the severity of adverse drug reactions, and different classifications are presented.

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References

  1. Stahlmann R, Lode H: Safety overview: toxicity, adverse effects and drug interaction. In: Andreoli V (ed): The quinolones. Academic Press, London, 1988, p. 201–233.

    Google Scholar 

  2. Gilbert DN: Guidelines for evaluating new antimicrobial agents. Journal of Infectious Diseases 1987, 156: 934–941.

    Google Scholar 

  3. Karch FE, Lasagna L: Adverse drug reactions. Journal of the American Medical Association 1975, 234: 1236–1241.

    Google Scholar 

  4. Schacht P: Adverse experiences with ciprofloxacin. Bayer, Leverkusen, 1986.

    Google Scholar 

  5. Jüngst G, Mohr R: Side-effects of ofloxacin in clinical trials and in postmarketing surveillance. Drugs 1987, 34, Supplement 1: 144–149.

    Google Scholar 

  6. World Health Organization: International drug monitoring — the role of the hospital. Drug Intelligence and Clinical Pharmacy 1970, 4: 101.

    Google Scholar 

  7. Green DM: Pre-existing conditions, placebo reactions and “side-effects”. Annals of Internal Medicine 1964, 60: 255–265.

    Google Scholar 

  8. Geddes AM: Studies of β-lactam antibiotics in systemic infections: some personal observations over 25 years. Reviews of Infectious Diseases 1986, 8, Supplement 3: 333–340.

    Google Scholar 

  9. Feinstein AR: Clinical biostatistics. XXVIII: The biostatistical problems of pharmaceutical surveillance. Clinical Pharmacology and Therapeutics 1974, 16: 110–123.

    Google Scholar 

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Authors and Affiliations

  1. Medical Department, Klinikum Steglitz, Freie Universität Berlin, Hindenburgdamm 30, 1000, Berlin 45, FRG

    H. Lode

  2. Institute for Toxicology, Freie Universität Berlin, 1000, Berlin 38, FRG

    R. Stahlmann

Authors
  1. H. Lode
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  2. R. Stahlmann
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Lode, H., Stahlmann, R. Evaluation of safety and tolerance in clinical trials with antimicrobial agents. Eur. J. Clin. Microbiol. Infect. Dis. 9, 530–533 (1990). https://doi.org/10.1007/BF01964297

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  • DOI: https://doi.org/10.1007/BF01964297

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