Toxicity test designs dose selection

This category includes agents for which there is less than the minimum sufficient evidence necessary for assessing the potential for developmental toxicity, such as when no data are available on developmental toxicity, as well as for databases from studies in animals or humans that have a limited study design (e.g. small numbers, inappropriate dose selection/exposure information, other uncontrolled factors), or data from a single species reported to have no adverse developmental effects, or databases limited to information on structure/activity relationships, shortterm tests, pharmacokinetics, or metabolic precursors. 

Many of the procedures used in conventional toxicity testing with animals have arisen by an apparently empirical process (e.g., period of exposure and selection of dose levels). Safety studies are performed with a variety of experimental animals, including rodents, rabbits, nonhuman primates, and farm animals, before progressing to studies with human volunteers, and other animals in the case of veterinary medicines. The individual study designs vary with the chosen animal species, route of administration, duration (dependent on the proposed or estimated exposure in... 

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