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Preclinical testing of a prototype medical device to treat cervical insufficiency

Michael House1, Devon C Campbell2, Dwayne Hickman3

  • 1Division of Maternal Fetal Medicine, Department of Obstetrics and Gynecology, Tufts Medical Center, 800 Washington Street, Boston, MA 02111.

American Journal of Obstetrics & Gynecology MFM
|November 24, 2023
PubMed
Abstract

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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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