Animal Study and Pre-clinical Trials of Biomaterials

An in vivo study is one of the most important steps in the process of translating biomaterials to clinical applications. It is mostly conducted to confirm in vitro results before going further to clinical trials. Appropriate use of animal models in the in vivo studies of biomaterials and medical devices is mandatory and should meet the approved regulations and ethics as defined by both local and international regulatory bodies. These studies involve the use of various approaches and protocols in order to know the body responses both local and systemic and to find out the short- and long-term responses of the body toward the implanted biomaterials or devices. This chapter describes complete procedures and practices of in vivo studies starting from selection of appropriate animal model, pre-implantation, surgical procedure and post-implantation, and monitoring of material-host responses. Some experiences of in vivo studies done by Indonesian researchers and the development of new implants are also presented.