AEIC (Adverse Effects Information Consulting) for New Drugs and Additives

Topics

■Cataracts and statins. A disproportionality analysis using data from VigiBase(RegToxXPharm,Vol.109)

■Subretinal transplantation of human embryonic stem cell-derived retinal pigment epithelium A09-hRPE): A safety and tolerability evaluation in minipigs(RegToxPharm. Vol.109)

■Drug-induced lenticular opacity and accumulation of cholesterol-related substances in the lens cortex of dogs(J_ToxSci., Vol.45)

■「医薬部外品・化粧品の安全性評価における眼刺激性試験代替法としての再構築ヒト角膜様上皮モデル法（RhCE 法）に関するガイダンスについて」（薬生薬審発 0624 第１号：令和元年6月）

■Outer retinal involvement in N-methyl-D-aspartate-induced inner retinal injury in rabbits assessed by optical coherence tomography(J_ToxSci., Vol.45)

■眼刺激性試験代替法の第三者評価報告書（案）：SIRC 細胞毒性試験 (眼刺激性試験代替法評価委員会)

■Anatomical and histological sex differences in the eye and its accessory tissues in Dutch belted rabbits (FundToxSci., Vol.5)

■Risk assessement of reproductive and developmental toxicity in eye-drop drugs: a consideration based on threshold of toxicological concern (FundToxSci., Vol.5)

■Repeated-dose ocular instillation toxicity study: a survey of its study design on the basis of common technical documentsin Japanof its study design on the basis of common technical documentsin Japan (FundToxSci., Vol.4)