Preclinical requirements

Abstract

There is a regular debate, which recently has become somewhat more intense and wide-ranging, concerning the amount of information on a potential new medicine which should be available before it can be tested in human subjects and then before it can be marketed. The universality of this debate is exemplified by the fact that in Scrip of 9 February Mr Patrick Jenkin, the UK Secretary of State for Social Services, was quoted as expressing‘his concern at the drain of clinical evaluation work on new drugs away from the UK to other countries because of the very lengthy pre-CTC testing requirements’. Five days later in Nature of 14 February the leading article was entitled ‘A dearth of new drugs’. This was a well-balanced article and it may be invidious to quote from it out of context but one particularly telling sentence read, ‘There may be a case for cutting back on animal testing but if so, it is only on quantity in a limited number of respects and not at all on quality’.