Description
Evaluation of the "acute" toxicity of drugs in accordance with national guidelines using
Conventional mice or mice of the SPF category (males and females), outbred conventional rats (males and females) with two ways of administering drugs. The number of doses studied: in mice - from 6 to 10; in rats, from 4 to 10. The number of mice in a group of 6 to 10 individuals; rats - from 5 to 10 individuals. The duration of the study - from 30 to 60 days.
Evaluation of the "acute" toxicity of drugs in accordance with national guidelines
using conventional rabbits of the Soviet Chinchilla breed (males and females) with one (recommended for clinical use) route of administration in the three studied doses of drugs.
The study includes: physiological studies, behavioral reactions, clinical, laboratory and pathological studies (histological examination of internal organs and tissues). The number of animals in the group from 3 to 5 individuals. The term of the study - 90 days.
Assessment of the “acute” toxicity of drugs in accordance with the methods of OECD (oral administration of drugs) using conventional mice or mice of the SPF category (males and females) with the oral route of administration in four doses of drugs studied. The number of mice in the group - from 3 to 5 individuals. The duration of the study - from 20 to 35 days.
Evaluation of "chronic / subchronic" toxicity of drugs in accordance with national guidelines using outbred rats (males and females)
with one (recommended for clinical use) route of administration in the three studied doses of drugs.
The study includes: physiological studies, behavioral reactions, clinical, laboratory and pathological studies (histological examination of internal organs and tissues). The number of animals in the group is from 10 to 20 individuals. The term of the study - 90 days.
Assessment of "chronic / subchronic" toxicity of drugs in accordance with national guidelines using conventional rabbits of the breed "Soviet Chinchilla (males and females) with one (recommended for clinical use) route of administration in two doses of drugs.
The study includes: physiological studies, behavioral reactions, clinical, laboratory and pathological studies (histological examination of internal organs and tissues). The number of animals in a group of 6 to 10 individuals. The duration of the study - from 90 to 180 days.
Assessment of "chronic / subchronic" toxicity of drugs in accordance with OECD methods (oral or percutaneous use of drugs) using out-bred rats (males and females) with one (recommended for clinical use) route of administration in the three doses of drugs studied.
The study includes: physiological studies, behavioral reactions, clinical, laboratory and pathological studies (histological examination of internal organs and tissues). The number of animals in the group is from 10 to 20 individuals. The term of the study - 90 days.
