Abstract
Making decisions in the development of drugs is a multifaceted and continuing process. Decisions must be made for scientific and commercial reasons in an ever-changing environment. In addition, the recent advent of molecular biology and a better understanding of cellular biochemistry are providing new perspectives on the initiation and progression of pharmacological research. The purpose of this chapter is to discuss scientific aspects of pharmacological and pharmaceutical development which go into decisions bearing on development programmes. While mention of commercial considerations will be made, these will not be covered in any depth. Furthermore, this chapter will not cover decisions to discontinue pharmacological development because of toxicological data or severe adverse reactions in people. For a detailed treatment of decisions in drug development, a monograph by Gross (1983) provides considerable information.
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Mamelok, R.D., Lessem, J. (1990). Decision Points in Human Drug Development. 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_10
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DOI: https://doi.org/10.1007/978-1-349-10705-6_10
Publisher Name: Palgrave, London
Print ISBN: 978-1-349-10707-0
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