Manufacturing dexamethasone intravitreal implants: Process control and critical quality attributes

Author:

Costello Mark A.ORCID,Liu Joseph,Wang Yan,Qin Bin,Xu XiaomingORCID,Li Qi,Smith William C.,Lynd Nathaniel A.,Zhang FengORCID

Funder

US Food and Drug Administration

Publisher

Elsevier BV

Subject

Pharmaceutical Science

Reference40 articles.

1. A study of drug release from homogeneous PLGA microstructures;Acharya;J. Control. Release.,2010

2. Allergan, 2022. Highlights of Prescribing Information, OZURDEX (dexamethasone intravitreal implant). https://www.rxabbvie.com/pdf/ozurdex_pi.pdf (accessed 06 February 2023).

3. ASTM D7264/D7264M−21. Standard Test Method for Flexural Properties of Polymer Matrix Composite Materials. West Conshohocken, PA: ASTM International; 2021.

4. Comparison of the tissue penetration and glide force of 22-gauge thin-wall needles for intravitreal implant administration;Bakri;Ophthalmic. Surg. Lasers. Imaging. Retina.,2014

5. Comparison of the release profile and pharmacokinetics of intact and fragmented dexamethasone intravitreal implants in rabbit eyes;Bhagat;J. Ocul. Pharmacol. Ther.,2014

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