Recent advances in rheological evaluation methods for generic semi-solid preparations
LI Yanjie
JIANG Dianzhuo
LIU Mengsi
ZHANG Zhongheng
LIU Yan
Abstract：Rheology plays a pivotal guiding role in the development of semi-solid preparations and serves as a core in-dicator for their quality evaluation and stability assessment.This article systematically reviews recent advances in rheological evaluation methodologies.It focuses on comparing the regulatory requirements for rheological characterization of generic semi-solid preparations set forth by FDA,EMA and NMPA,highlighting the stringent statistical standards of EMA and their re-cent updates.The article discusses current methods for evaluating rheological equivalence,aiming to provide methodological references and practical guidance for researchers and regulatory submission units.
Keywords：Semi-solid preparationsGeneric drugsRheologyRegulatory requirementsEquivalence evaluationConfi-dence interval approach
Publication Date：2025-11-30
Online Publishing Date：2025-12-24(First online date of this platform, not the publication date of the document)
Pages：5( 1083-1086,1097 )