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12月16-18日，由中國藥理學會和上海市藥理學會聯(lián)合舉辦的第四屆東方藥理論壇暨上海市藥理學會第二十二屆學術年會在上海舉行，本屆年會采取線上線下相結合的方式。

環(huán)特生物研究員戴明珠受邀在青年優(yōu)秀論文報告專場做題為《Validation, optimization and application ofzebrafish developmental toxicity assay forpharmaceuticals under ICH S5(R3) guideline》的學術報告，該研究成果由環(huán)特生物、浙江省醫(yī)學科學院(杭州醫(yī)學院)安全性評價研究中心、浙江省醫(yī)學科學院(杭州醫(yī)學院)浙江省藥品安全評價與研究重點實驗室、浙江工業(yè)大學長三角綠色制藥協(xié)同創(chuàng)新中心共同發(fā)表，榮獲第四屆東方藥理論壇青年優(yōu)秀論文報告獎（三等獎）。

該研究成果《依照ICH S5(R3)原則建立了斑馬魚發(fā)育毒性測試模型及其應用》，具有較高的科研水平和學術價值， 現(xiàn)已發(fā)表在SCI期刊《Frontiers in Cell and Developmental Biology》（JCR分區(qū)：發(fā)育生物學類1區(qū)，IF=6.684）上。

其是在ICH指導原則下，驗證并優(yōu)化了先前由美國和歐洲的多個實驗室間研究報告的斑馬魚發(fā)育毒性測定，并證實了：斑馬魚作為一種發(fā)育毒性與致畸性試驗的替代動物模型，可達到90.3%靈敏度（28/31個陽性化合物對具有致畸作用）和 88.9% (40/45) 總體可預測性。這項研究結果充分支持使用斑馬魚作為替代體內方法來篩選和評估候選藥物的發(fā)育毒性與致畸性以供監(jiān)管、使用，可用于新藥IND人體臨床實驗申請。

此次獲獎是對環(huán)特生物科研實力的再次肯定，截至目前，環(huán)特生物已發(fā)表斑馬魚科研論文120余篇，申請57項國家發(fā)明zhuanli，其中，已獲授權27項，主持起草斑馬魚技術應用團體標準11項，其中4項已發(fā)布實施。

未來，環(huán)特生物將堅持技術創(chuàng)新，以高質量的斑馬魚技術服務，持續(xù)推出高水平學術成果，助力更多的科研院所、企業(yè)在斑馬魚技術領域實現(xiàn)產學研深度融合，助力健康與美麗產業(yè)高質量發(fā)展！

論文摘要

The zebrafish as an alternative animal model for developmental toxicity testing has been extensively investigated, but its assay protocol was not harmonized yet.

This study has validated and optimized the zebrafish developmental toxicity assay previously reported by multiple inter-laboratory studies in the United States and Europe.

In this study, using this classical protocol, of 31 ICH positive compounds, 23 compounds (74.2%) were teratogenic in zebrafish, 5 had false negative results, and 3 were neither teratogenic nor non-teratogenic according to the protocol standard; of 14 ICH negative compounds, 12 compounds (85.7%) were non-teratogenic in zebrafish and 2 had false positive results.

After we added an additional TI value in the zebrafish treated with testing compounds at 2 dpf along with the original 5 dpf, proposed a new category as the uncategorized compounds for those TI values smaller than the cut-off both at 2 dpf and 5 dpf but inducing toxic phenotypes, and refined the testing concentration ranges, optimized the TI cut-off value from ≥ 10 to ≥ 3 for compounds with refined testing concentrations, this optimized zebrafish developmental assay reached a 90.3% sensitivity (28/31 positive compounds were teratogenic in zebrafish) and 88.9% (40/45) overall predictability.

Our results from this study strongly support the use of zebrafish as an alternative in vivo method for screening and assessing teratogenicity of candidate drugs for regulatory acceptance.