【摘要】：抗腫瘤抗體偶聯(lián)藥物通過靶向釋放藥物,可降低細胞毒藥物的毒性風險,提高治療指數(shù)�？贵w偶聯(lián)藥物的組成復雜,與裸單抗和細胞毒藥物相比,抗體偶聯(lián)藥物的研發(fā)具有更大的挑戰(zhàn)。本文基于ICH S6和ICH S9等指導原則,探討了抗腫瘤抗體偶聯(lián)藥物的非臨床藥理、安全性以及藥動學研究的關(guān)注點和考慮。
[Abstract]:Anti-tumor antibody coupling drugs can reduce the risk of cytotoxicity and improve the treatment index by targeted release of drugs. The composition of antibody coupling drugs is complex, and the development of antibody coupling drugs is more challenging than naked monoclonal antibodies and cytotoxicity drugs. Based on the guiding principles of ICH S6 and ICH S9, the non-clinical pharmacology, safety and pharmacokinetics of antitumor antibody coupling drugs were discussed in this paper.
【作者單位】： 國家食品藥品監(jiān)督管理局藥品審評中心;
【分類號】：R96
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本文編號：2484664