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BENEDICTINE UNIVERSITY EDUC 200 Preclinical Level 1 with Seminar Spring 2017 Benedictine Universities Conceptual Framework: Benedictine University educators are effective practitioners, committed
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Preclinical level 1 refers to the initial stage of testing and evaluation of a new drug or treatment before it is tested in humans. This includes laboratory and animal studies to gather safety and efficacy data.
Researchers, pharmaceutical companies, or organizations that are developing new drugs or treatments are required to file preclinical level 1 with the relevant regulatory authorities.
Filing preclinical level 1 typically requires completing specific forms provided by regulatory agencies, detailing the research design, methodology, results, and plans for further studies.
The purpose is to evaluate the safety and biological activity of a potential new drug before it can proceed to clinical trials in humans.
Information that must be reported includes study design, objectives, results from laboratory and animal studies, safety data, and plans for subsequent clinical studies.
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