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RESULTS OF PRECLINICAL SAFETY TESTING COMPARISON FOR IBUPROFEN DRUG PRODUCTS

Abstract

The article contains materials, methods and results of preclinical experimental test of acute toxicity of drugs «Ibuprofen», suspension for oral administration [for children], LP 001651 from 13.04.2012 and referent «Nurofen for children», suspension for oral administration, P N014745/01 from 22.08.2008. Ibuprofen preparations compared were found equivalent in acute toxicity studies. The work will be continued in order to prove the bioequivalence of the claimed preparations.

About the Authors

E. A. Sitnikova
CJSC «Ekolab»
Russian Federation


S. G. Mardanly
State University of Humanities and Technology
Russian Federation


E. P. Rogozhnikova
CJSC «Ekolab»; State University of Humanities and Technology
Russian Federation


References

1. Mironov A. N. Manual for preclinical studies of drugs. (in Russian). T. 1. - M.: FGBU «NCEHMSP», 2012. P. 942.

2. Manual on experimental (preclinical) study of new pharmacological substances. (in Russian). M.: Medicina, 2005. P. 41-53.

3. Supervisory methodical materials on experimental and clinical the study of new drugs (Official publication). V 1, 3. Pharmacological Committee. (in Russian). M., 1975, 1981.

4. Federal law № 61 at 12.04.2010 «Аbout the address of drugs» (in Russian).

5. Hodge H. et al. Clinical Toxicology of Commercial Products. Acute Poisoning. Ed. IV. Baltimore, 1975. P. 427.


Review

For citations:


Sitnikova E.A., Mardanly S.G., Rogozhnikova E.P. RESULTS OF PRECLINICAL SAFETY TESTING COMPARISON FOR IBUPROFEN DRUG PRODUCTS. Drug development & registration. 2018;(4):86-88. (In Russ.)

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ISSN 2305-2066 (Print)
ISSN 2658-5049 (Online)