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广东省高水平新型研发机构
State Key Laboratory of Ophthalmology (Research Center for Non clinical Evaluation of Ophthalmic Drugs)
Key Laboratory of Non Clinical Evaluation of Drugs in Guangdong Province
炎症与免疫相关疾病教育部基础研究创新中心
创新药物评价与研究广东省工程研究中心
Guangdong Innovative Drug Evaluation and Research Engineering Technology Research Center
Guangdong Provincial Engineering Technology Research Center for Ophthalmic Drug Creation and Evaluation
One stop public service platform for research, development and evaluation of cell and gene therapy drugs in Guangdong-Hong Kong-Macao Greater Bay Area
Non clinical Evaluation Center for Traditional Chinese Medicine, National Research Center for Modernization of Traditional Chinese Medicine
广东省企业技术中心
Key technology platform for research and evaluation of chiral drugs
Innovative drug research and molecular imaging technology and product research technology platform
Guangdong-Hong Kong-Macao Greater Bay Area Anti tumor Drug R&D and Evaluation Center
Key technology platform for pharmacokinetics research
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Areas of Strength in Evaluation and Research
Ophthalmic drugs
Cell And Gene Therapy Products
Pediatric medicine
Traditional Chinese Medicine
Vaccines And Anti-Infective Drugs
Topical Preparation For Skin
Inhalation Preparations
Dependence And Psychiatric Drug Evaluation Platform
Ophthalmic drugs
莱恩医药共建有
广东省眼科药物创制与评价工程技术研究中心、眼病防治全国重点实验室(眼科药物非临床评价研究中心)
,专注于眼科药物非临床评价近10年,配备了先进的眼科仪器设备,掌握了各种眼部特殊给药技术和分析手段,并组建了一支经验丰富的技术团队,
可为各类眼科药物提供科学、优质、高效、专业的一站式非临床试验研究服务!
多种眼部特殊给药途径:
眼局部给药:
·
眼局部外用(滴眼液、眼膏、眼用凝胶)
·
眼周注射(球结膜下、球筋膜下、眼球后)
·
眼球内注射(前房、玻璃体腔)
·
眼底用药(视网膜下腔)
全身给药:
·
口服、肌肉注射、静脉注射
·
血-眼屏障:取决于药物的脂溶性
·
脂溶性高的药物容易通透血-眼屏障,进入眼内
完善的眼科硬件检查设施
一站式服务内容
1.药代动力学
· 精密的眼部手术:可将眼部分离成十四个组织;
· 成熟的眼部组织采样、匀浆以及检测技术;
· 完成超过30个创新眼科药物PK研究
2.药效学研究
成熟的药效评价体系,绝大部分模型有新药申报经验
3.安全性评价
丰富的项目经验,拥有各种属各年龄段的背景研究数据
服务成果
· 已完成近1000项眼科药物非临床研究,包括5个生物制品,12个1类新药,8个2类新药,4个儿童眼科用药全套非临床评价及近百个眼科仿制药的安全性评价
· 助力获批眼科创新药临床批件1类新药近40个,2类新药18个,3类及4类仿药已获批件近百项。