Research advances in preclinical safety evaluation ofbiotechnology-derived pharmaceuticals
LU Qiu-jun
DING Lin-mao
Abstract：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.
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Publication Date：2001-01-01
Online Publishing Date：2026-08-14(First online date of this platform, not the publication date of the document)
Pages：5( 252-256 )