P3333.2.5.5 - Standard for In Vivo Evaluation of 3D Printed Polymeric scaffolds in bone defects
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This document specifies the in vivo examination required for the biological assessment of three-dimensional (3D) bio-printed polymeric scaffolds intended for use in bone regeneration. 3D bio-printed scaffolds are gaining increased attention and animal experiments are fundamental in assessing their performance prior to potential clinical use. In vivo assessment will include the following features. Animal model include rat or rabbit. Bone defect can be created on the skull, femur or pelvis. The defect size is minimum 5mm3 in volume. Assessment include histopathological, radiological and mechanical assessment.
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Par Approval
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