Methodological approaches to the assessment of pharmaceutical substances neurotoxicity

2018

Регуляторные исследования и экспертиза лекарственных средств, Vol 7, Iss 2, Pp 111-116 (2018)

The article reviews methodological approaches to the assessment of pharmaceutical substances neurotoxicity. It describes the main battery of animal tests that are conducted prior to clinical trials in order to assess drug effects on the functioning of vital body systems. The article addresses the choice of animal species, dosage and duration of pharmaceutical substance administration, as well as the conduct of clinical trials, functional tests and histological studies. It points out that an adequate justification of the study programme may help substantially reduce the number of tests. The authors assert the need to use at least two animal species in neurotoxicity studies, one of which must be a non-rodent species, in order to be able to investigate the drug safety profile during preclinical studies in as much detail as possible and to assure the required safety level for people when moving on to Phase I of clinical trials.

article

Russian

Federal State Budgetary Institution ‘Scientific Centre for Expert Evaluation of Medicinal Products’ of the Ministry of Health of the Russian Federation (FSBI ‘SCEEMP’), 2018.

нейротоксичность, нервная система, координация движений, сенсорные реакции, когнитивные функции, фармакологическая безопасность, лабораторные животные, neurotoxicity, nervous system, motor coordination, sensory reactions, cognitive functions, safety pharmacology, laboratory animals, Medicine (General), R5-920