Considerations of the quality management and inspection of pharmacology and toxicology studies
YUAN Ming
CHEN Yi-fei
Abstract：Pharmacology and toxicology studies are important evaluation component in drug research and development,and the first line of defense before the application of innovative drugs in humans.In accordance with the international guidance and Chinese regulatory requirements,non-clinical safety evaluation study of drugs should be conducted at institutions certified by the good laboratory practice(GLP),and in compliance with the GLP.Although some pharmacological studies and pharmacokinetic studies are not required to be conducted under GLP conditions,data reliability remains a basic requirement,which shall comply with regulatory requirements and might be inspected.Through analyzing the focus areas of on-site inspections,this paper discusses the quality management of pharmacology and toxicology studies,and explores the risk management of pharmacology and toxicology studies and corresponding inspections.The aim of this paper is to provide guidance for pharmacology and toxicology studies institutions to improve study quality through the construction of quality management system.Meanwhile,it also provides reference for the inspection of pharmacology and toxicology studies.
Keywords：pharmacology and toxicology studiesinspectionquality managementcompliance
Publication Date：2025-08-03
Online Publishing Date：2026-08-14(First online date of this platform, not the publication date of the document)
Pages：5( 1704-1708 )