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Medicine and Health Sciences

Virginia Commonwealth University

Theses and Dissertations

2017

Biorelevant

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A Biorelevant In Vitro Model To Characterize In Vivo Release Of Bone Morphogenetic Protein-2 (Rhbmp-2), Deblina Biswas Jan 2017

A Biorelevant In Vitro Model To Characterize In Vivo Release Of Bone Morphogenetic Protein-2 (Rhbmp-2), Deblina Biswas

Theses and Dissertations

Biorelevant in vitro release/dissolution tests are designed to predict the in vivo behavior of a drug and are crucial in understanding its in vivo performance. Currently, there is no standardized compendial in vitro release testing methods or regulatory guidance’s for release/dissolution testing of implants due to their complex physiological locations.Furthermore, existing compendial methods do not capture the local release profile of ‘novel’ parenterals in physiological low fluid volume surrounding areas.

Long acting and in situ forming implants with orthobiologic proteins and peptides have increased over the past few decades due to a better understanding of genetic engineering. One of these …