Abstract
The progression of a drug from animal to human studies probably represents the single most important step in drug development. However, the design of the initial human evaluation study is associated with a great deal of uncertainty. Although there are a number of general reviews of Phase I studies (Vaidya and Vaidya, 1981; Burley and Glynne, 1985; Rogers and Spector, 1986), there is a lack of guidance regarding the initial human evaluation; consequently, practice varies considerably between investigators. It is the aim of this chapter to review the important decisions to be made after completion of satisfactory preclinical work and the relative advantages and disadvantages of different study designs, all of which allow the dose of a drug to be escalated from a low to a high level with safety as a primary concern.
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References
Burley, D. M. and Glynne, A. (1985). In Burley, D. M. and Binns, T. B. (Eds.), Pharmaceutical Medicine Clinical Trials. Edward Arnold, London, pp. 70–109
Carter, S. K., Selawry, O. and Slavik, M. (1977). Methods of development of new anti cancer drugs. Clinical trials in cancer chemotherapy. Cancer, 40, 544–57
Dollery, C. T. and Davies, D. S. (1970). The conduct of initial studies in man. Br. Med. Bull., 26, 233–6
Hansen, H. H. (1970). Clinical experience with 1-(2-chloroethyl)3-cyclohexyl-1-nitrosourea (CCNU NSC 79037). Proc. Am. Ass. Cancer Res., 11, 43
Pitts, N. E. (1974). In MacMahon, F. (Ed.), Principles and Techniques of Human Research and Therapeutics, Volume II: Drug-induced Clinical Toxicity. Futura, New York, pp. 19–35
Rogers, H. J. and Spector, R. G. (1986). In Glenny, G. and Nelmer, P. (Eds.), Handbook of Clinical Drug Research. Phase I Studies. Blackwell Scientific, Oxford, pp. 33–58
Vaidya, A. B. and Vaidya, R. A. (1981). Initial human trials with an investigational new drug. J. Postgrad. Med., 27, 197–213
Von Hoff, D. D., Kuhn, J. and Clark, G. M. (1984). In Buyse, M. E., Staquet, M. J. and Sylvester, R. J. (Eds.), Cancer Clinical Trials Methods and Practice; Design and Conduct of Phase I Trials. Oxford University Press, Oxford, pp. 210–20
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Broom, C. (1990). Design of First-administration Studies in Healthy Man. 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_16
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DOI: https://doi.org/10.1007/978-1-349-10705-6_16
Publisher Name: Palgrave, London
Print ISBN: 978-1-349-10707-0
Online ISBN: 978-1-349-10705-6
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