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Preclinical development consists of a series of tests that ensure the safety and efficacy of a new therapeutic compound before it is tested in humans. There are four main phases to this process. First, safety pharmacology tests are conducted to ensure the drug does not produce any acutely harmful effects. These tests examine parameters such as bronchoconstriction, cardiac dysrhythmias, blood pressure changes, and ataxia. Next, preliminary toxicological testing is performed to determine the...
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Experience With Pediatric Medical Device Development

H David Humes1, Angela J Westover1

  • 1Division of Nephrology, Department of Internal Medicine, University of Michigan Medical School, Ann Arbor, MI, United States.

Frontiers in Pediatrics
|April 23, 2020
PubMed
Summary

No abstract available in PubMed .

Keywords:
childhumanitarian use deviceimmunomodulationmedical deviceorphan diseasesrenal replacement therapy

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