The Board of the EurAsian Commission adopted the Guidelines for conducting preclinical toxicity studies with repeated (multiple) administration of active substances of medicinal products intended for medical use.
The manual contains information on the organization, conduct and presentation of the results of a study of the toxic effects of new drug molecules under conditions of their repeated prolonged use in test systems. Special sections concern the determination of potential target organs of the toxic effects of drugs in humans, as well as the study of the potential reversibility of toxic effects in humans. This approach allows us to predict the safety of the use of a future drug in humans even before conducting clinical trials. Recommendations are also given on the observance of the quality of the active substance produced for research, the choice of its dosage regimen and route of administration.
The manual is harmonized with similar requirements of the European Union. Its provisions, firstly, apply to drugs that are developed on the basis of new molecules, secondly, they are used to study drugs based on well-known molecules, if the manufacturer changes its dosage form - for example, instead of cream or ointment, it begins to produce a drug in the form of tablets, thirdly, they are used in the production of drugs, which are new combinations of drugs. Thus, the document supplements the system of acts of the Union relating to the preclinical phase of the study of a medicinal product.
The application of the Guide will help to eliminate national differences in the approaches to planning and evaluating the volume of research, and to eliminate duplication of preclinical toxicological studies by manufacturers of new drugs in the Union countries.