In the process of scientific discovery and eventual translation of this information to the clinic, a fundamental step is exploration of the safety and efficacy of these discoveries in preclinical studies. These questions are addressed in animal models that provide a sufficient level of reproducibility. Fundamental discovery also demands animal systems in which reagents (e.g., antibodies and probes) are readily available and turnover of individuals and the occurrence of biologic events are rapid. Therefore, the study of animals with short development and life cycles (days to months) provides the best opportunities for initial detection and observation of the process under study. Common choices for initial feasibility research include Drosophila melanogaster (fruit fly), Caenorhabditis elegans (nematode worm), Danio rerio (zebra fish), and many varieties of Mus musculus (mouse) and Rattus norvegicus (rat). Development of knockout and transgenic animals has greatly increased the rate of fundamental biologic discovery in the past decade. Feasibility testing is almost always performed in small mammals, specifically mice and rats, in which outcomes can be determined after relatively short periods of observation; reagents are readily available; and the variations in radiographic, imaging, histologic, or biochemical outcomes among individuals are small. Many standard models for the assessment of implant materials in small mammals have been described in standard protocol documents published by major standards and regulatory organizations, including the American Society for Testing and Materials (ASTM), International Standards Organization (ISO), U.S. Food and Drug Administration (FDA), and European Commission.
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