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Developments in Tissue Engineered and Regenerative Medicine Products by J Ludlow, J Basu

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9

Pre-clinical clinical evaluation of TE/RM products

Abstract

There is an established pathway for pharmaceutical compound development and review by the FDA. Developers of TE/RM products have to improvise certain parts of this established pathway, especially regarding ADME Tox testing. Both in vitro and in vivo animal testing is required before the FDA will allow any medicinal product to be tested in humans. These studies need to be well defined, controlled and monitored. Development and execution of a clinical trial rely heavily on the experience of the clinical investigator, who works in close collaboration with the study sponsor. For small companies who may not have the depth of experience required to monitor the study within their own employees, ...

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