Biomaterials Commons^™

Assessment Of The Biocompatibilty, Stability, And Suitability Of Natural And Synthetic Polymers And Drugs In The Fda Approval Process, Phuong Anh Hoang Nguyen

Biomedical Engineering ETDs

Regulation of the development, production, marketing, and sales of medical pharmaceuticals and devices in the United States fall under the regulatory functions of the Food and Drug Administration (FDA). The current FDA approval process takes an average of 10 years from start to completion, and costs over $100 million. As a result, companies use many different methods to find additional use of their drugs through marketing directly to the physician, or recycling of previously approved drug moieties. In this work, an evaluation of the in vitro and ex vivo biocompatibility of polymers and drugs in different phases of FDA approval …

Degradable Zinc Material Characteristics And Its Influence On Biocompatibility In An In-Vivo Murine Model, Roger J. Guillory Ii

Dissertations, Master's Theses and Master's Reports

Biodegradable stents based on zinc have been under development since their introduction in 2013. While metallic zinc is highly ductile, it unfortunately lacks the mechanical strength required for arterial stents. This has led to the development of an abundance of novel zinc-based materials, with the aim of improving the mechanical strength without sacrificing too much ductility. Although these materials are intended to function and slowly degrade within an artery, most zinc-based materials have been developed without deep consideration for their biological effects.

The present work explores the biological effects elicited by zinc-based materials implanted within the arterial system. The biological …