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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
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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
Inhalation Preparations
技术实力
莱恩医药已开展过
各类吸入剂型
药物非临床评价研究,并熟练掌握各类
呼吸道给药
方式。
气管内雾化
吸入给药是一种在动物气管内直接将药物精确定量雾化的一种给药方方式,分
干粉雾化
和
液体雾化
,是吸入给药药物在临床前早期研究用来探究药代动力学情况的常用给药方式。
口鼻动态吸入暴露
:口鼻暴露装置由动物暴露系统、气溶胶发生器、控制调节系统等部分组成,其
系统气密性好,暴露浓度均一
,可实现
多动物给药、多参数检测、多功能考察
;适用于液体气溶胶、粉尘气溶胶、纳米颗粒气溶胶、烟气等可吸入物的口鼻吸入染毒实验。
压缩式雾化吸入给药
能模拟临床给药方式,并且
可以准确定量,提供不同粒径雾化液
,是吸入药物临床前药效、药代、毒理常用的吸入给药方法。
研究经验
1、案例分享
治疗COPD药物口服改吸入药代:
靶组织暴露量显著提高;可大大降低给药剂量。
治疗性功能障碍药物口服改吸入药代:
药物起效时间显著增快;给药剂量可显著降低
2、已建模型
近几年承担的吸入给药制剂的非临床评价研究项目经验
服务成果
已开展
三十余项
吸入制剂临床前研究,包括1类中药、化药、生物制品、2类改良型化药、生物制品以及多个仿制药;
已获批批件20余个,包含多个1、2类化药新药以及生物制品!