By Alan Poole, George B. Leslie
First released in 1989, this e-book recognizes that new medicinal drugs, nutrition ingredients and different compounds must be conscientiously screened for poisonous side-effects. the majority of this examine is dedicated to the sensible questions of 'what toxicological stories should still we perform?' and 'how should still we practice them?' Compounds which endure toxicity trying out should be comfortably categorized as these that are meant for management to guy and people which aren't. the previous comprise prescribed drugs for use medicinally or prophylactically and chemical compounds that are additional to our nutrients, beverages or drugs to enhance their balance, visual appeal or palatability. because it is on prescribed drugs that the main accomplished toxicological reviews are commonly played, this e-book has been directed essentially in the direction of to toxicological review of capability new medicinal drugs. the rules and method of toxicological evaluate of different varieties of compounds are primarily related.
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Additional info for A Practical Approach to Toxicological Investigations
First it must be recognised that the dosing is not very accurate. Often animals are not caged singly so that the best estimate of the amount they have eaten can only be the mean for the cage. Another problem is that very few drugs have no taste - pleasant or unpleasant. The taste of a drug can influence the amount of food consumed and it is well established that the dietary intake of an animal plays an important role in its health, survival and rate of tumour incidence. g. clinical chemistry parameters (see Chapter 5), thereby possibly giving a false indication of a toxicological response.
Riley, V. (1975) Tumours: alterations of incidence an apparent function of stress. Science, 189, 465-567. The Royal Society & UFAW (1987) Guidelines on the Care of Laboratory Animals and their Use for Scientific Purposes. The Royal Society and the Universities Federation for Animal Welfare, London. Tucker, M. (1979) Effect of long term diet restriction on tumours in rodents. International Journal of Cancer, 23, 803-12. Young, S. S. (1987) Are there local room effects on hepatic tumours in male mice?
This species should be one in which the pharmacological activity of the rDNA compound can be demonstrated to be the same as in man, or other good biological reasons should be given for its selection. All guidelines appear to place great emphasis on testing for neutralising antibodies since it is feared that the absence of a toxic effect may simply be due to the compound being 'neutralised' by antibodies. Dose levels: it is suggested that only two dose levels be used; one at the therapeutic level with the other ten times higher.