Safety Pharmacology Studies of Medicinal Products: Evaluation of Results

Abstract

The article substantiates approaches to evaluation of results obtained in preclinical safety pharmacology studies. It describes historical background for the development of regulatory requirements and methodological recommendations for performance of such studies, provides a classification of various types of safety pharmacology studies, lays down general requirements for examination of the main battery of tests as well as subsequent and additional tests, examines the aims and main tasks of such studies, and cites examples of tests. The authors define the main scope of expert evaluation which includes the methodological basis of studies, results of studies, characterisation of a medicine’s safety profile, interpretation of preclinical data, assessment of risk factors and an anticipated clinical safety profile for patients.

Keywords

• лекарственные средства
• фармакологическая безопасность
• доклинические исследования безопасности
• экспертные критерии
• интерпретация результатов исследований
• medicines
• safety pharmacology
• preclinical safety studies
• expert criteria
• interpretation of study results