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Order No. 101 of the Ministry of Agriculture validating the Regulation on preclinical research of a medicinal product for veterinary use, clinical study of a medicinal preparation for veterinary use, bioequivalence study of a medicinal preparation for veterinary use.

País/Territorio
Federación de Russia
Tipo de documento
Reglamento
Fecha
2018
Fuente
FAO, FAOLEX
Materia
Ganado
Palabra clave
Sanidad animal Medicamentos Investigación Recopilación de datos/informes
Área geográphica
Ártico, Asia y Pacifico, Mar Negro, Mar Caspio, CEI (Comunidad de Estados Independientes), Europa Oriental, Europa, Europa y Central Asia, Pacífico Norte, Pacífico Nordoeste
Resumen

This Order establishes the procedure for preclinical research of a medicinal product for veterinary use, clinical study of a medicinal preparation for veterinary use, bioequivalence study of a medicinal preparation for veterinary use. Preclinical research, clinical research (including bioequivalence research) shall be conducted according to the plan approved by the developer of the medicinal preparation (drug) for veterinary use, keeping records of these studies and the compilation of reports containing the results of these studies. Pre-clinical studies include: (a) study of the pharmacodynamics of the active ingredient (s) of a medicinal product for veterinary use (drugs), including the study of the specific (pharmacological) activity of the drug; (b) study of the general toxic properties of the drug (including acute, subchronic and (or) chronic toxicity, local irritant effect of the drug); (c) study of the specific toxicity of the drug (including immunotoxicity, allergenicity, reproductive toxicity, teratogenicity, embryotoxicity, mutagenicity with a carcinogenicity prediction); (d) study of the tolerance of healthy animals to those species for which the drugs under study are intended for veterinary use, with single and repeated administration in therapeutic (preventive) and elevated doses; (e) study of the pharmacokinetics of the active ingredient (active substances) of the medicinal product and (or) its metabolite (metabolites) in the body of the target animals; (f) study of the timing of the removal of residual quantities of active ingredient (s) and (or) its metabolite (metabolites) from the organism of target productive animals in order to ensure the safety of products of animal origin after the application of the corresponding medicinal preparation for veterinary use (drug) in the maximum recommended by the developer dose. The collection, processing and storage of information obtained during preclinical research should ensure that a reliable and substantiated opinion of the safety and pharmacological activity of the drug is obtained. The possibility of a clinical testing shall be based upon the results of preclinical research. The bioequivalence study is a type of clinical study carried out to determine the rate of absorption and excretion of one or more pharmacologically active substances and (or) their metabolites, the amount of the drug reaching the systemic blood flow and the results of which lead to a conclusion about the bioequivalence of the reproduced drug in a certain medical form and dosage corresponding to the medical form and dosage of the reference medication.

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pravo.gov.ru