CAJ | 학술논문

生物技术药物是用现代生物技术生产的一类特定药物，主要种类包括基因重组的细胞因子或生长因子、单克隆抗体、疫苗、基因治疗制剂和反义核酸等。本文介绍了国际协调会议（ICH）有关生物技术药物临床前安全性评价指导原则一些要点，阐明了各类生物技术药物临床前安全性评价的具体要求并举例说明。
생물기술약물시용현대생물기술생산적일류특정약물，주요충류포괄기인중조적세포인자혹생장인자、단극륭항체、역묘、기인치료제제화반의핵산등。본문개소료국제협조회의（ICH）유관생물기술약물림상전안전성평개지도원칙일사요점，천명료각류생물기술약물림상전안전성평개적구체요구병거례설명。
Biotechnology-derived pharmaceutical is a special class of drug manufactured by biotechnology.Its main varieties include recombinant cytokines and growth factors,monoclonal antibodies,vaccines,gene therapy and antisense olignucleotide.In this paper,some important parts of ICH(International Conference on Harmonisation) document,Guidance on Preclinical Safety Evaluation of Biotechnology-Derived Pharmaceuticals,are introduced.