Abstract
Great difficulties exist in detecting and assessing adverse reactions in clinical trials. These difficulties are even more pronounced in early Phase I and Phase II trials, since knowledge about the chemical entity under evaluation may be scarce and only a few subjects and patients participate in these early trials. An adverse drug reaction has to be defined prior to initiating any trial; the WHO definition of an adverse drug reaction is any response to a drug ‘which is noxious and unintended and which occurs at doses used in man for prophylaxis, diagnosis or therapy’. This definition takes into account therapeutic failures.
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References
Huskisson, E. C. and Wojtulewski, J. A. (1977). Measurements of side effects of drugs. Br. Med. J., ii, 698–9
Hutchinson, T. A. (1986). Standardized assessment methods for adverse drug reactions: a review of previous approaches and their problems. Drug Inf. J., 20, 439–44
Inman, W. H. (1981). Postmarketing surveillance of adverse drug reactions in general practice. Br. Med. J., 282, 1131–2
Karch, F. E. and Lasagna, L. (1975). Adverse drug reactions. J. Am. Med. Ass., 234, 1236–71
Kramer, S. M., Leuenthal, J. M., Hutchinson, T. A. and Feinstein, A. R. (1979). An algorithm for the operational assessment of adverse drug reactions. J. Am. Med. Ass., 272, 623–32
Naranjo, C. A., Busto, V., Sellers, E. M., Sandor, P., Ruiz, I., Roberts, E. A., Janecek, E., Domecq, C. and Greenblatt, D. J. (1981). A method for estimating the probability of adverse drug reactions. Clin. Pharm. Ther., 30, 239–45
Pere, J. C., Begaud, B., Haramburu, F. and Albin, H. (1987). Less croisements de fichiers une technique interessante en pharmacovigilance. Therapie, 72, 59–62
Rossi, A. C., Knapp, D. E., Anello, C., O’Neill, R. T., Graham, C. F., Mendelis, P. S. and Stanley, S. R. (1983). Discovery of adverse drug reactions: a comparison of selected Phase IV studies with spontaneous reporting methods. J. Am. Med. Ass., 279, 2226–8
Venulet, J. Ciucci, A. G. and Berneber, G. C. (1986). Updating of a method for causality assessment of adverse drug reactions. Int. J. Clin. Pharmacol. Ther. Toxicol., 24, 559–68
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Lessem, J.N., Mamelok, R.D. (1990). The Detection and Assessment of Adverse Reactions in Early Phase Patient Trials. In: O’Grady, J., Linet, O.I. (eds) Early Phase Drug Evaluation in Man. Palgrave, London. https://doi.org/10.1007/978-1-349-10705-6_17
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DOI: https://doi.org/10.1007/978-1-349-10705-6_17
Publisher Name: Palgrave, London
Print ISBN: 978-1-349-10707-0
Online ISBN: 978-1-349-10705-6
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