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A phased approach to drug development
Authors:J M Fromson
Affiliation:Division of Chemical and Medical Sciences, Hazleton UK, Harrogate, England.
Abstract:
It is possible in the UK to carry out a phased approach to drug development that is designed to assist in the selection of a candidate drug for development from a series of compounds; minimize the amount of animal work (toxicological and metabolic) necessary to permit early evaluation in man; introduce a more rational basis for decision making by setting criteria that must be satisfied before entry can be made into the next phase of development; obtain safety, pharmacokinetic, and possibly dynamic data in man within about 16 months of receipt of the compound.
Keywords:
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