美國食品藥品管理局(FDA)于2023年12月28日發(fā)布了題為"局部外用眼科藥品的質(zhì)量考慮"的指導原則草案,對2023年10月發(fā)布的同名指導原則草案進行了修訂。該指導原則草案討論了用于眼內(nèi)和眼周局部給藥的眼用產(chǎn)品,包括凝膠、軟膏、乳膏和液體制劑等劑型的眼用制劑的一些質(zhì)量考慮,涵蓋質(zhì)量研究中微生物學、可見顆粒物、可提取物和可浸出物、雜質(zhì)和降解產(chǎn)物、穩(wěn)定性研究5個方面,并對容器密封系統(tǒng)(CCS)設(shè)計等提出了相關(guān)建議。詳細介紹FDA該指導原則草案主要內(nèi)容,期望對該類藥物的研發(fā)和質(zhì)量評價有所啟示。

On December 28, 2023, the U. S. Food and Drug Administration (FDA) issued "Quality Considerations for Topical Ophthalmic Drug Products Draft Guidance for Industry " The guidance revised the draft guidance of the same name released in October 2023. Considerations for some quality studies of ophthalmic products intended for topical administration into and around the eye, including gels, ointments, creams, and liquid formulations such as solutions, suspensions, and emulsions, are discussed, covering five aspects of quality research:Microbiology, visible particulate matter, extractables and leachables, impurities and degradation products, and stability research, and elaborates on relevant suggestions for design of container closure system (CCS), etc. This article introduces the main contents of the FDA's guidance in detail, hoping to shed some light on the research and development of this type of drug.

R951