Bioethical And Economic Aspects In The Basis Of A Choice Of A Method Of Studying Of Toxicity Of Medical Products At Single Introduction

Avdeeva O.I., Makarova M.N., Kalatanova A.V., Kovaleva M.A. HOUМ OF PHARMACY Research-and-Production Association; 3, Zavodskaya St., Build. 245, Kuzmolovsky Urban-Type Settlement, Vsevolozhsky District, Leningrad Region, 188663, Russia e-mail: avdeeva.oi@doclinika.ru

Abstract

The study of the general toxicity of medicines is an important aspect of their preclinical study, since it allows one to assess the risks in clinical trials. The results of the toxicity study with a single administration allow not only to justify the dose for toxicity studies with repeated administration and specific types of toxicity, but also to evaluate the feasibility of further study of the drug. The analysis of experimental toxicity study with a single administration of the reproduced ritonavir preparation was carried out, during which it was proved that toxicity studies with a single administration should be carried out in two kinds of animals and using both sexes of animals to exclude species and gender specificity, literature data on lethal doses of substances can not be absolutely extrapolate to the toxicity of the drug in the finished dosage form, if it is necessary to study the toxicity in a wide range of doses, it is advisable to use the design of the protocol OECD 425.

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