All of the following is in cells or animals
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c) The trial involves a drug, biological, or device product that is manufactured in the United States or its territories and is exported for research. 4 See 5 See 6 See 7 See 8 It also referenced other policy documents, including the 1993 International Conference on Harmonization (ICH) guideline, which advised against arbitrary upper-age cutoffs in clinical trials that may result in underrepresentation of older adults
Based on the landmark Baar et al
10.1016/j.cell.2018.10.001 47 KalamkarS.AcharyaJ.Kolappurath MadathilA.GajjarV.DivateU.Karandikar-IyerS.et al (2022)
The mechanism likely involves the same angiogenic pathway: bone repair is acutely dependent on vascularization of the fracture gap, and BPC-157's VEGF-stimulating activity addresses this bottleneck directly