By Alan Poole, George B. Leslie
First released in 1989, this e-book recognizes that new medications, meals ingredients and different compounds have to be rigorously screened for poisonous side-effects. the majority of this research is dedicated to the sensible questions of 'what toxicological reviews should still we perform?' and 'how should still we practice them?' Compounds which endure toxicity checking out might be very easily 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 nutrition, beverages or drugs to enhance their balance, visual appeal or palatability. because it is on prescribed drugs that the main entire toxicological reviews are often played, this publication has been directed essentially in the direction of to toxicological assessment of strength new medicines. the foundations and method of toxicological review of alternative forms of compounds are primarily related.
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Extra info for A Practical Approach to Toxicological Investigations
It is to be hoped that eventually there will be soundly based, practicable GLP standards which are not unnecessary and do not put excessive burdens on those responsible for conducting toxicological investigations. 3 REQUIREMENTS FOR CLINICAL TRIALS AND MARKETING For drug development it is essential to know, as early as possible, if the test agent will produce the desired pharmacological effect in man and also, as discussed previously, to have information on human kinetics and metabolism. It is therefore necessary that toxicology and clinical studies parallel one another, with of course the clinical investigations 22 Regulatory requirements running behind the toxicological investigations.
Standard pelleted diets for dogs are available from several commercial companies. They are usually provided with a full analysis of content, and dogs on such diets require no other food supplements. Some form of dietary restriction is needed, particularly for long term studies, in order to avoid the problem of obesity. Such restriction can be in the length of time the food is presented but is more usually in the quantity offered. 5 NON-HUMAN PRIMATES Simians of various types are widely used in toxicology studies and while a few are bred in captivity, most are still captured in the wild.
The latter course of action is extremely costly and may require up to seven years' experimentation. Although such studies have been undertaken with contraceptive steroids, in general, for practical reasons, the rat and mouse remain the animals of choice for carcinogenicity studies. Group sizes The minimum number of animals in treatment groups is dictated by the regulatory authorities (see Chapter 2) and is discussed for individual studies later in this chapter. However, in a complex situation, perhaps studying an effect which occurs only rarely but is of great biological importance, it may be advisable to increase the numbers of experimental animals.