Safety Evaluation: International Regulations for Drug and

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Language: English

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To explore dose, substances are tested in both acute and chronic models. [9] Generally, different sets of experiments are conducted to determine whether a substance causes cancer and to examine other forms of toxicity. [9] Factors that influence chemical toxicity: [7] The classic experimental tool of toxicology is animal testing. [7] As of 2014, animal experiments provide information that is not available by other means about how substances function in a living organism. [11] While testing in animal models remains as a method of estimating human effects, there are both ethical and technical concerns with animal testing. [12] Since the late 1950s, the field of toxicology has sought to reduce or eliminate animal testing under the rubric of "Three Rs" - reduce the number of experiments with animals to the minimum necessary; refine experiments to cause less suffering, and replace in vivo experiments with other types, or use more simple forms of life when possible. [13] [14] In some cases shifts away from animal studies has been mandated by law or regulation; the European Union (EU) prohibited use of animal testing for cosmetics in 2013. [15] Computer modeling is an example of alternative testing methods; using computer models of chemicals and proteins, structure-activity relationships can be determined, and chemical structures that are likely to bind to, and interfere with, proteins with essential functions, can be identified. [16] This work requires expert knowledge in molecular modeling and statistics together with expert judgment in chemistry, biology and toxicology. [16] Most chemicals display a classic dose response curve – at a low dose (below a threshold), no effect is observed. [7] :80 Some show a phenomenon known as sufficient challenge – a small exposure produces animals that "grow more rapidly, have better general appearance and coat quality, have fewer tumors, and live longer than the control animals". [17] A few chemicals have no well-defined safe level of exposure.

Pages: 376

Publisher: CRC Press; 1 edition (December 1, 2009)

ISBN: 084933098X

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