Interpretation of"Guideline for Pharmaceutical Research of Chemical Generic Drug Oral Solutions"
WANG Gongfu
TANG Jia
YANG Qiao
Abstract：Oral solutions have the characteristics of uniform dose distribution,flexible dosage administration,and good patient compliance,and has been paid more attention in the field of domestic drug development in recent years.In order to promote the development of domestic generic drugs and clarify the pharmaceutical technical requirements in the research and development process of chemical generic drug oral solutions,the Center for Drug Evaluation of National Medical Prod-ucts Administration officially issued the"Guideline for Pharmaceutical Research of Chemical Generic Drug Oral Solutions"on July 8,2024.This article provides a detailed interpretation,combined the drafting process of the guideline,in order to fa-cilitate better understanding and application by related researchers.
Keywords：Generic drugOral solutionsGuidelineInterpretation
Publication Date：2025-06-30
Online Publishing Date：2025-08-21(First online date of this platform, not the publication date of the document)
Pages：5( 572-575,588 )