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In a previous post we noted the increasing importance of biologics as therapeutic agents, with 37% of the drugs approved by the FDA in 2017 being biologic entities. A recent article in Chemical & ...
Animal studies are generally conducted for a longer duration, generally three to six months, and are conducted using multiple doses. The purpose of these studies is to determine target-organ toxicity, to determine the effects of prolonged dosing, and to help establish margins of safety for food additives and drugs. At the end of a study all animals are autopsied, with complete gross and microscopic examination of tissues. Complete blood chemistries are evaluated and an overall clinical assessment is made on each animal. These studies are usually conducted under the Good Laboratory Practices (GLP) guidelines
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