Preview

Legal regulation in veterinary medicine

Advanced search

OECD Chemicals Testing Regulation: validity for toxicological studies

https://doi.org/10.52419/issn2782-6252.2023.4.119

Abstract

In order to validate the methods used to determine the toxicity of drugs, researchers usually turn to the most authoritative scientific literature, the system of state standards, or alternative systems. One of them is the OECD (Organization for Economic Co-operation and Development) regulations on testing chemicals.
The article provides a brief analysis of the OECD regulations for testing chemicals (in particular, Chapter 2 “Effects on Biotic Systems” and Chapter 4 “Effects on Health”), which is a set of internationally recognized specifications for testing chemicals approved by the Organization for Economic Co-operation and development.
The basic principles of conducting an experiment, the requirements for biological models for research, and the general system for assessing a particular type of toxicity were assessed.
The main benefit of applying the OECD regulation in the context of toxicological studies is that it ensures uniformity of approaches and methodology in assessing chemical safety at the international level. This facilitates the comparison of research results, as well as the exchange of information between countries and organizations. Data quality control and adherence to GLP principles also provide confidence in research results, which is the basis for decision-making in chemical regulation and the protection of human, animal and environmental health. In general, OECD regulations in the context of toxicological research play an important role in ensuring safety and protecting public health and the environment. It provides standards and recommendations that facilitate the effective assessment of chemical safety and the development of appropriate measures to ensure it.

About the Author

V. S. Ponamarev
St. Petersburg State University of Veterinary Medicine
Russian Federation

Vladimir S. Ponamarev



References

1. Gushchina, S. V. Comparative toxicological study of carriers for drugs used in preclinical studies / S. V. Gushchina, M. N. Makarova, O. N. Pozharitskaya // International Veterinary Bulletin. – 2015. – No. 3. – P. 92-98.

2. Assessment of the toxic effect of some carriers used in preclinical studies / O. I. Avdeeva, M. N. Makarova, A. E. Katelnikova, M. S. Simanovskaya // International Veterinary Bulletin. – 2016. – No. 4. – P. 90-96.

3. Guskova, T. A. Preclinical toxicological study of drugs as a guarantee of the safety of their clinical studies / T. A. Guskova // Toxicological Bulletin. – 2010. – No. 5(104). – P. 2-5.

4. The role of toxicological studies in the development of medicines of plant origin / L. V. Krepkova, T. D. Dargaeva, O. N. Tolkachev, N. I. Sidelnikov // Issues of ensuring the quality of medicines. – 2015. – No. 5(10). – pp. 37-42.

5. Expert assessment of preclinical studies of drug toxicokinetics (review) / R. D. Syubaev, G. N. Engalycheva, D. V. Goryachev [et al.] // Chemical-Pharmaceutical Journal. – 2018. – T. 52, No. 9. – P. 3-7. – DOI 10.30906/0023-1134-2018-52-9-3-7.

6. Analysis of the results of preclinical studies of the safety of drugs / G. N. Engalycheva, R. D. Syubaev, V. A. Merkulov, A. N. Vasiliev // Bulletin of the Scientific Center for Expertise of Medicinal Products. Regulatory research and examination of medicines. – 2013. – No. 2. – P. 9-11.

7. Preclinical assessment of the safety of drugs containing combinations of known drugs / R. D. Syubaev, I. N. Nemkova, G. N. Engalycheva [etc.] // Toxicological Bulletin. – 2014. – No. 5(128). – P. 2-7.

8. Features of planning and conducting preclinical studies of drugs for veterinary use / G. V. Konovalova, P. S. Lobova, V. A. Gritsyuk [etc.] // Veterinary Medicine. – 2022. – No. 2. – P. 58-62. – DOI 10.30896/0042-4846.2022.25.2.58-62.

9. Guidelines for experimental (preclinical) study of new pharmacological substances. Under the general editorship of R.U. Khabrieva - 2nd edition, revised and expanded. - Moscow: Publishing House "Medicine", 2005. - 832 p.

10. Guidelines for conducting preclinical studies of medicines / Scientific Center for Expertise of Medical Products of the Ministry of Health and Social Development of Russia. Volume Part 1. – Moscow: Grif i K, 2012. – 944 p. – ISBN 978-5-8125-1466-3.

11. Gourmelon, A. Developing Test Guidelines on invertebrate development and reproduction for the assessment of chemicals, including potential endocrine active substances—The OECD perspective / A. Gourmelon, Ju. Ahtiainen // Ecotoxicology. – 2007. – Vol. 16, No


Review

For citations:


Ponamarev V.S. OECD Chemicals Testing Regulation: validity for toxicological studies. Legal regulation in veterinary medicine. 2023;(4):119-121. (In Russ.) https://doi.org/10.52419/issn2782-6252.2023.4.119

Views: 100


Creative Commons License
This work is licensed under a Creative Commons Attribution 4.0 License.


ISSN 2782-6252 (Print)