Preclinical Guidelines: A Reply
I would like to comment on certain topics addressed by this session’s lecturers illustrating my presentation with examples mostly from personal experiences in the regulatory area of the U.K. pharmaceutical industry. I will try to avoid the peculiarity (in a European context) of extensive data requirements for performance of U.K. clinical trials; these are under review and likely to be rationalized considerably in the near future. In effect, U.K. guidelines have meant that preclinical data in the U.K. have had to be supplied earlier than elsewhere in the drug registration pathway and that much of the clinical research on U.K.-discovered drugs has been carried out abroad. (A figure of 80% was quoted at a recent meeting.) The U.K. authorities have been criticised for tending toward the search for absolute safety and away from the encouragement of new drug development. It was recently stated that 97% of research work carried out by one of the largest U.K. pharmaceutical companies was abortive, largely due to the extensive tests conducted on compounds later abandoned at the early clinical stage. I will come back to this point a little later with reference to costs involved, but I suppose one of my basic pleas is to get drugs into man for testing somewhat earlier in their development.
KeywordsSodium Cromoglycate Short Term Test Chronic Toxicity Testing Early Clinical Stage Hypo Thesis
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