Abstract
There is a growing national concern with drugs in our society, including the ways in which drugs are developed, tested, and marketed by pharmaceutical companies, the extent and effectiveness of the Food and Drug Administration’s (FDA) control, and the possibility of unforeseen long-range harmful effects to individuals taking certain drugs.
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References
Arbit, H. M., 1978, Regulatory aspects of investigational new drugs, Am. J. Hosp. Pharm. 35:81–85.
Donehew, G. and Schaumberg, J. P., 1979, The pharmacist’s role as a member of the institutional review board, Hosp. Pharm. 14:509–519.
Hassan, W. E., Jr., 1965, Hospital Pharmacy, pp. 75–87, Lea and Febiger, Philadelphia.
Herbst, A. L., Ulfelder, H., and Poskanzer, D., 1971, Adenocarcinoma of the vagina, association of maternal stilbesterol therapy with tumor appearance in young women, N. Engl. J. Med. 284(16):878–881.
Hiranaka, P. K., and Gallelli, J. F., 1979, Investigational drugs in the hospital, in: Handbook of Institutional Pharmacy Practice (M. C. Smith and T. R. Brown, eds.) pp. 382–397, Williams & Wilkins, Baltimore.
Kaganov, A. L., 1980, Medical device development: Innovation versus regulation, Ann. Thora. Surg. 29:331–335.
Kelsey, F. O., 1965, Problems raised for the FDA by the occurrence of thalidamide embryopathy in Germany, Am. J. Publ. Health 55:703–707.
Kleinman, L. M., and Tangera, J. A., 1974, Involvement of the hospital pharmacist in single and double-blind studies, Am. J. Hosp. Pharm. 31:979–981.
Kleinman, L. M., Tangera, J. A., and Gallelli, J. F., 1974, Control of investigational drugs in research hospitals, Am. J. Hosp. Pharm. 31:368–371.
Lanton, R. L., 1965, A community-wide project for the collection of adverse drug reaction reports, Am. J. Hosp. Pharm. 22(8):470.
Lasagna, L., 1968, General considerations concerning untoward effects of drugs in man, Proceedings of the Third International Pharmacological Meeting Sao Paulo, Brazil, Vol. 3 (M. Rocha e Silva, ed.), p. 84, Pergamon Press, Oxford.
Lasagna, L., and Wardell, W., 1975, The rate of new drug discovery, in: Drug Development and Marketing (R. B. Helms, ed.), p. 157, American Enterprise Institute for Public Policy Research.
Luy, M. L., 1976, Package Insert Roulette: The “Catch 23” of prescribing, Mod. Med. (Chicago) 1976:20–23.
Mandl, F. L., Greenberg, R. B., 1976, Legal implications of preparing and dispensing drugs under conditions not in a product’s official labeling, Am. J. Hosp. Pharm. 33:814–816.
Stephen, S. P., and McKinley, J. D., 1974, Investigational drug information in a cancer research hospital, Am. J. Hosp. Pharm. 31:372–374.
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© 1982 Plenum Press, New York
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Ryan, M.K., Gold, L., Kay, B. (1982). Research on Investigational New Drugs. In: Greenwald, R.A., Ryan, M.K., Mulvihill, J.E. (eds) Human Subjects Research. Springer, Boston, MA. https://doi.org/10.1007/978-1-4684-4157-4_8
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DOI: https://doi.org/10.1007/978-1-4684-4157-4_8
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