Pharmaceutical Toxicology is the Most Important Component of Preclinical Studies

Abstract

The first principle for ensuring patient safety is to do no harm (primum non nocere). It clearly justifies why the legislative requirements for the safety of medicinal products should be strict and meticulous. The aim of preclinical safety evaluation is to protect public health by preventing the clinical use of medicinal products with a potentially unfavourable risk–benefit profile. Traditionally, toxicology is defined as the study of the adverse effects of chemical substances on living organisms. Toxicity studies are integral to preclinical programmes for new medicinal products. The role of toxicology in preclinical studies is explained in this interview by Corresponding Member of the Russian Academy of Sciences, Doctor of Medical Sciences, and Full Professor Andrey D. Durnev. Dr. Durnev is a laureate of the State Prize of the Russian Federation. He holds the positions of Head of the Pharmaceutical Toxicology Department of V.V. Zakusov Institute of Pharmacology, Chairman of the Commission of the Ministry of Health of the Russian Federation for the Certification of Experts for the Right to Perform Regulatory Evaluation of Medicinal Products for Human Use, and Deputy Chairman of the Interdepartmental Council of the Russian Academy of Sciences on the Scientific Substantiation and Maintenance of Drug Policy of the Russian Federation.

Keywords

• pharmaceutical toxicology
• preclinical studies
• genotoxicity studies