关键词: 生物3D打印, 药物研发, 组织工程, 再生医学, 非临床模型, 动物模型

Abstract:

Animal experimentation plays an indispensable role in the development of biomedicine, significantly contributing to drug safety, toxicity, efficacy assessment, and mechanism research. However, in recent years, the challenges for animal experimentation have been increasing. In response to these challenges, in September 2022, the U.S. Senate passed the "FDA Modernization Act 2.0 (S.5002)," which removes the federal mandate requiring animal testing for FDA approval of new drugs before human clinical trials, a requirement in place since 1938. This act formally promotes the use of non-animal models in preclinical trials. 3D bioprinting models, characterized by their high biomimicry, heterogeneity, and high-throughput capabilities, have emerged as a prime example of these alternative methods. This review briefly introduces the technical methods of 3D bioprinting and its applications in drug development, tissue engineering, and its intersection with animal models. The aim is to explore the current progress and future prospects of bio-3D printing models in the biomedical field and their relationship with animal models, providing valuable insights for professionals in the biomedical community.

Key words: 3D Bioprinting, Drug development, Tissue engineering, Regenerative medicine, Non-clinical Models, Animal model