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12月16-18日，由中國藥理學(xué)會(huì)和上海市藥理學(xué)會(huì)聯(lián)合舉辦的第四屆東方藥理論壇暨上海市藥理學(xué)會(huì)第二十二屆學(xué)術(shù)年會(huì)在上海舉行，本屆年會(huì)采取線上線下相結(jié)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(bào)告專場做題為《Validation, optimization and application ofzebrafish developmental toxicity assay forpharmaceuticals under ICH S5(R3) guideline》的學(xué)術(shù)報(bào)告，該研究成果由環(huán)特生物、浙江省醫(yī)學(xué)科學(xué)院(杭州醫(yī)學(xué)院)安全性評(píng)價(jià)研究中心、浙江省醫(yī)學(xué)科學(xué)院(杭州醫(yī)學(xué)院)浙江省藥品安全評(píng)價(jià)與研究重點(diǎn)實(shí)驗(yàn)室、浙江工業(yè)大學(xué)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(bào)告獎(jiǎng)（三等獎(jiǎng)）。

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(yīng)用》，具有較高的科研水平和學(xué)術(shù)價(jià)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(xué)類1區(qū)，IF=6.684）上。

其是在ICH指導(dǎo)原則下，驗(yàn)證并優(yōu)化了先前由美國和歐洲的多個(gè)實(shí)驗(yàn)室間研究報(bào)告的斑馬魚發(fā)育毒性測定，并證實(shí)了：斑馬魚作為一種發(fā)育毒性與致畸性試驗(yàn)的替代動(dòng)物模型，可達(dá)到90.3%靈敏度（28/31個(gè)陽性化合物對(duì)具有致畸作用）和 88.9% (40/45) 總體可預(yù)測性。這項(xiàng)研究結(jié)果充分支持使用斑馬魚作為替代體內(nèi)方法來篩選和評(píng)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(shí)驗(yàn)申請(qǐng)。

此次獲獎(jiǎng)是對(duì)環(huán)特生物科研實(shí)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(qǐng)57項(xiàng)國家發(fā)明zhuanli，其中，已獲授權(quán)27項(xiàng)，主持起草斑馬魚技術(shù)應(yīng)用團(tuán)體標(biāo)準(zhǔn)11項(xiàng)，其中4項(xiàng)已發(fā)布實(shí)施。

未來，環(huán)特生物將堅(jiān)持技術(shù)創(chuàng)新，以高質(zhì)量的斑馬魚技術(shù)服務(wù)，持續(xù)推出高水平學(xué)術(shù)成果，助力更多的科研院所、企業(yè)在斑馬魚技術(shù)領(lǐng)域?qū)崿F(xiàn)產(chǎn)學(xué)研深度融合，助力健康與美麗產(chǎn)業(yè)高質(zhì)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.