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The goal of laboratory research is the accumulation of data to address issues related to development, quality assurance or control, product design, adaptive responses or induced cellular or molecular changes, mode of action, efficacy, safety, toxic effects, security assessments, and other engineering or manufacturing variables or critical attributes needed to support policy and decision making by regulatory agencies
In addition, one area of scientific research, biomedical research, includes studies on human subjects intended to advance knowledge that may facilitate the development of safe and effective products useful for diagnostic, therapeutic, or other novel and beneficial purposes
A test article is any food, medical or radiation-emitting product or product intended for human use that undergoes ex vivo, biological, chemical, physical or microbiological testing or in vivo studies throughout lifecycle stages such as preclinical development, clinical growth, early market release or post-market surveillance
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