By Alan Poole, George B. Leslie
First released in 1989, this ebook recognizes that new medicines, nutrients ingredients and different compounds have to be rigorously screened for poisonous side-effects. the majority of this learn is dedicated to the sensible questions of 'what toxicological reviews may still we perform?' and 'how should still we practice them?' Compounds which endure toxicity trying out should be very easily labeled 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 substances that are additional to our nutrition, beverages or medication to enhance their balance, visual appeal or palatability. because it is on prescribed drugs that the main accomplished toxicological reviews are as a rule played, this publication has been directed basically in the direction of to toxicological evaluate of strength new medications. the rules and method of toxicological review of different sorts of compounds are basically comparable.
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Extra resources for A Practical Approach to Toxicological Investigations
Additional testing: if there is clear evidence of maternal toxicity some type of reproductive toxicity programme should be undertaken. Naturally modified protocols with shorter treatment periods may be necessary if the rDNA product is antigenic. Mutagenicity studies are also likely to be required, especially on those materials which differ significantly from the natural product. g. residual cellular DNA or 28 Regulatory requirements viruses. It is, however, more likely that modern analytical techniques will prove more useful for such measurements.
It is, however, a wise precaution on receipt of rodents to carry out some basic microbiological tests and other health screens. This ensures that batches of animals are free from diseases or abnormalities which might affect the course of the study or infect other animals. On arrival in the facility animals should be marked, for identification purposes, and allowed to acclimatise to their new environment and diet. This acclimatisation period should last for at least two weeks before the commencement of a study, during which time various pretest measurements can be made.
The full package of reproductive studies (see Chapter 8) are, however, required for the therapeutic trials (lib and III). Also, before administration to man, some countries, such as the UK, demand that chemicals have been examined in a genotoxicity assay (see Chapter 8). Intravenous/perivenous irritancy studies and perineural studies may also be required prior to clinical trials with intravenous formulations. There are several reasons for carrying out clinical trials as early as possible. These include determination of possible differences in drug metabolism between man and the experimental animal, the effectiveness of the drug in man and an idea of the anticipated human dose.
A Practical Approach to Toxicological Investigations by Alan Poole, George B. Leslie