Quality Assurance System when Studying the Pharmacological Safety of Etmaben
https://doi.org/10.33647/2074-5982-20-3-71-74
Abstract
Quality assurance plays a key role in preclinical research, where every detail must be strictly controlled and verified. Standard operating procedures are essential part of any quality assurance system, defining precisely the steps and methods of implementing certain tasks or processes in a laboratory. In this article, the main components of a quality assurance system are discussed using the example of studying the pharmacological safety of a malonic acid derivative.
About the Authors
A. Yu. Grishina
Saint Petersburg State Chemical and Pharmaceutical University of the Ministry of Health Care of Russia
Russian Federation
Russian Federation
Anna Yu. Grishina
197376, Saint Petersburg, Professora Popova Str., 14, lit. A
D. Yu. Ivkin
Saint Petersburg State Chemical and Pharmaceutical University of the Ministry of Health Care of Russia
Russian Federation
Russian Federation
Dmitry Yu. Ivkin, Cand. Sci. (Biol.), Assoc. Prof.
197376, Saint Petersburg, Professora Popova Str., 14, lit. A
S. M. Napalkova
Saint Petersburg State Chemical and Pharmaceutical University of the Ministry of Health Care of Russia
Russian Federation
Russian Federation
Svetlana M. Napalkova, Dr. Sci. (Biol.), Prof.
197376, Saint Petersburg, Professora Popova Str., 14, lit. A
O. V. Buyuklinskaya
Saint Petersburg State Chemical and Pharmaceutical University of the Ministry of Health Care of Russia
Russian Federation
Russian Federation
Olga V. Buyuklinskaya, Dr. Sci. (Med.), Prof.
197376, Saint Petersburg, Professora Popova Str., 14, lit. A
References
1. GOST 33044-2014. Printsipy nadlezhashchey laboratornoy praktiki (s Popravkoy) [Principles of Good Laboratory Practice (with Amendment)]: Moscow: Standardinform Publ., 2019:16. (In Russian)].
2. GOST R 56700-2015. Lekarstvennye sredstva dlya meditsinskogo primeneniya. Doklinicheskie farmakologicheskie issledovaniya bezopasnosti [Medicines for medical use. Preclinical pharmacological safety studies]. Moscow: Standardinform Publ., 2016:8. (In Russian)].
3. URL: https://www.consultant.ru/document/cons_doc_LAW_366430
Review
For citations:
Grishina A.Yu., Ivkin D.Yu., Napalkova S.M., Buyuklinskaya O.V. Quality Assurance System when Studying the Pharmacological Safety of Etmaben. Journal Biomed. 2024;20(3):71-74. (In Russ.) https://doi.org/10.33647/2074-5982-20-3-71-74
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