A phased approach to drug development

Summary 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.SeeJ. Pharmacokin. Biopharm. 17:521–523.