Issues and perspectives on the biocompatibility and immunotoxicity evaluation of implanted controlled release systems

作者: James M Anderson , John J Langone

DOI: 10.1016/S0168-3659(98)00178-3

关键词:

摘要: Over the past decade, significant advances and discoveries in cell molecular biology biomaterials have provided a foundation for research development of new, complex controlled release systems. Many these new systems utilize active biological components, i.e., proteins cells, to achieve their intended therapeutic goal. Utilization bioactive materials implantable has prompted broad as well an in-depth interest safety efficacy This short review is provide individuals with perspective on standards guidance documents which specifically address immunotoxicity response evaluation from regulatory point view.

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