Abstract
In most countries radiopharmaceutical drugs have now become recognized as substances which require reviewing and acceptance by a governmental agency before the medical profession is allowed their unrestricted use. However many uncertainties still exist about the basis for reviewing. Usually radiopharmaceuticals do not fit the concepts which apply to pharmaceuticals in general. Therefore it is often extremely unsatisfactory to apply the rules, developed for the evaluation of drugs to the process of evaluating a radioactive drug. In this presentation we will try to explore to what extent evaluation procedures accepted in the evaluation of pharmaceuticals may or may not be used in evaluating radiopharmaceuticals.
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References
General considerations for the clinical evaluation of drugs.1977 HEW (FDA) 77–3040.
Guidelines for the clinical evaluation of radiopharmaceutical drugs. 1981 HEW (FDA) 81–3120.
Legal and practical requirements for the registration of drugs. 1980, Zurich, I. F. P. M. A.
Feinstein AR. The architecture of clinical research. Clin Pharm Ther 1970;11: 432–41
Bell RS. Efficacy. What ’s that. Sem Nucl Med 1978; 8: 316–23
Wagner HN. Bayes ’Theorem: an idea whose time has come? AmJ Cardiol 1982; 49: 875–77
Hamilton GN, Trobaugh GB, Ritchie JL et al. Myocardial imaging with Thallium-201: an analysis of clinical usefulness based on Bayes’ Theorem. Sem Nucl Med 1978; 8: 358–64
Nosslin B. Quality control and data evaluation in nuclear medicine. Proc. 13th Int. Annual Meeting of the Soc. of Nucl. Med. Sept. 1975, Copenhagen. 307–15.
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© 1984 Martinus Nijhoff Publishers, Boston
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de Jong, R., Huising, W.B. (1984). Comparative Evaluation of Drugs. In: Kristensen, K., Nørbygaard, E. (eds) Safety and efficacy of radiopharmaceuticals. Developments in Nuclear Medicine, vol 4. Springer, Dordrecht. https://doi.org/10.1007/978-94-009-6753-3_14
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DOI: https://doi.org/10.1007/978-94-009-6753-3_14
Publisher Name: Springer, Dordrecht
Print ISBN: 978-94-009-6755-7
Online ISBN: 978-94-009-6753-3
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