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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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First-in-human operations require more than technical excellence

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The Journal of Heart and Lung Transplantation : the Official Publication of the International Society for Heart Transplantation
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No abstract available in PubMed .

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