Practical and Regulatory Aspects of the Study and Control of Polymorphism in Pharmaceutical Development (Review)
摘要
The article reviews the impact of polymorphism on the quality, efficacy, and safety of drugs. The methodology of approaches to the study of polymorphism and the assessment of risks associated with it at pharmaceutical development stages and subsequent state registration of original and generic drugs is described within the framework of an analysis of the main international and domestic regulations defining the procedures for screening and control of polymorphic forms in pharmaceutical substances and drugs.