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Titlebook: Medicines and Risk/Benefit Decisions; Stuart R Walker (Director of the Centre for Medici Book 1987 MTP Press Limited 1987 care.clinical tr

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both useful and informative and, hopefully, the publication of these proceedings will stimulate further discussion in this important area which may improve the decision-making process in drug development. The Editors wish to thank the participants for contributing to the Work­ shop, together with Dr. Cyndy Lu978-94-010-7946-4978-94-009-3221-0
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Risk predicted from animal studies experiments are performed before a marketing licence is requested, came into force almost 50 years ago. During this time, toxicological testing has developed into an enormously laborious effort, whose cost-effectiveness is now seriously disputed. Moreover, a third party, the drug regulatory agencie
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The risk identified from clinical trialsf factors such as dose, route of administration, duration of exposure and individual (usually genetic) predisposition. The reason that toxicology, both in animals and in man, often does appear to be more of an art than a science is that prescribers, regulators and industrialists usually have to make
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The risk determined from PMS studies relatively small number of factors which are likely to change at any one time. Mostly these are known and can be measured. Moreover, in most instances the time scales between first exposure and termination of the experiment are short, thus minimizing the period during which intervening variables ca
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Economic benefitsosts, and these savings can be quantified in a number of ways. Second, the existence and activities of the industry make a direct economic contribution to the wealth of the country, in just the same way as other industries manufacturing any other types of goods for home consumption and for export. T
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