Discussion on the overall requirements and focus points for quality research of chemical generic ophthalmic preparations
Due to the sensitivity of the eyes and their unique anatomical and physiological characteristics,ophthalmic preparations require stricter quality control compared to other topical preparations.Through preliminary literature research and daily review,mainly based on the relevant domestic/foreign technical guidelines and regulatory requirements,we discuss the quality research of chemical generic ophthalmic preparations.This mainly included the overall requirements for quality research and other concerns,such as microbiological considerations,drug release/dissolution,and stability design.Through the discussion in this article,we hope to provide some reference for the development of generic ophthalmic preparations,especially complex preparations or for regulatory agencies in China.
Ophthalmic drug productsComplex dosage formsQuality researchRelease or dissolutionMicrobiological considerations
万方数据
维普
