Discussion on pharmaceutical research of overfilling for generic injections
DONG Chenhuan
JIANG Xifeng
GONG Qing
ZHANG Xinfang
Abstract：Overfilling of generic injections was a key issue that needs to be focused in the process of drug development,manufacturing and registration review.This article summarized the regulatory requirements of domestic and foreign drug regu-latory agencies for overfill,and analyzed the concerns,typical cases and common problems of overfill research from the per-spective of review,aiming to provide references for the development,manufacturing and the registration of injection generic drugs of overfill.
Keywords：OverfillInjectionOverage
Publication Date：2024-11-28
Online Publishing Date：2025-08-15(First online date of this platform, not the publication date of the document)
Pages：5( 1096-1100 )