The safety evaluation of long-acting ocular delivery systems

被引:20
|
作者
Thackaberry, Evan A. [1 ]
Lorget, Florence [2 ]
Farman, Cindy [3 ]
Bantseev, Vladimir [4 ]
机构
[1] Ra Pharmaceut, 87 Cambridge Pk Dr, Cambridge, MA 02140 USA
[2] Sangamo Therapeut, 501 Canal Blvd, Richmond, CA 94804 USA
[3] Farman Pathol, Reno, NV 89431 USA
[4] Genentech Inc, 1 DNA Way, San Francisco, CA 94080 USA
关键词
FLUOCINOLONE ACETONIDE IMPLANT; SINGLE INTRAVITREAL INJECTION; LATANOPROST CATIONIC EMULSION; DRUG-DELIVERY; INTRAOCULAR PHARMACOKINETICS; PLGA MICROSPHERES; TISSUE REACTION; RHESUS-MONKEYS; MACULAR EDEMA; IN-VITRO;
D O I
10.1016/j.drudis.2019.05.032
中图分类号
R9 [药学];
学科分类号
1007 ;
摘要
The safety evaluation of ocular long-acting delivery (LAD) technologies is a nascent field. Here, we detail the challenges in assessing the safety of novel LAD technologies, and well as the most common types of toxicity encountered during early toxicity testing. A detailed understanding of the route of administration, pharmacology, and functionality and/or pharmacokinetics (PK) of the LAD, along with all of its component parts, including the active pharmaceutical ingredient and excipients, is crucial for the successful development of next-generation long-acting ocular therapeutics.
引用
收藏
页码:1539 / 1550
页数:12
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