History and current status of biological tests in Russia
Abstract
«Pyrogenicity» and «Abnormal Toxicity» are considered to be among most problematic pharmacopoeia monographs in the current editions of the leading world pharmacopoeias, the reasonability of which is not obvious to all experts. The authors analyze the reasons for the introduction and history of the elaboration of biological methods for drug quality control, as well as major prospects for their further development in Russia.
About the Authors
M. S. Ryabtseva
Scientific Centre for Expert Evaluation of Medicinal Products
Russian Federation
Russian Federation
T. A. Batuashvili
Scientific Centre for Expert Evaluation of Medicinal Products
Russian Federation
Russian Federation
G. A. Sapozhnikova
Scientific Centre for Expert Evaluation of Medicinal Products
Russian Federation
Russian Federation
N. P. Neugodova
Scientific Centre for Expert Evaluation of Medicinal Products
Russian Federation
Russian Federation
Yu. V. Olefir
Scientific Centre for Expert Evaluation of Medicinal Products
Russian Federation
Russian Federation
V. A. Merkulov
Scientific Centre for Expert Evaluation of Medicinal Products
Russian Federation
Russian Federation
References
1. The State Pharmacopoeia of the USSR. 9th ed. Moscow: Medgiz; 1961 (in Russian).
2. Schechtman LM. The Safety Assessment Process — Setting the Scene: An FDA Perspective. ILARJ 2002; 43(Suppl 1): S5–S10. Available from: http://ilarjournal.oxfordjournals.org/.
3. History of Federal Regulation: 1902–Present. Available from: http://www.fdareview.org/history.shtml.
4. Krylov YuF, Kivman GYa. Biological control of drug safety. Moscow: Meditsina; 1985 (in Russian). 5. U.S.P. 12th edition. 1942.
5. Sitnikov AG, Travina LA, Bagirova VL. LAL test. Modern approaches to the determination of pyrogenicity. Moscow; 1997 (in Russian).
6. European Pharmacopoeia. 6th edition. 2010.
7. Cussler K. The Scientific Relevance of the ATT—Today and from a historical Perspective. Available from: https://circabc.europa.eu/sd/a/713b9d43 – 9383 – 4681- a46a-054c6249c40b/ihb%20sept%202015%205%20Case%20study%201 Klaus%20Cussler.pdf.
8. Garbe IHO, Osborne C, Beggs K, Bopst M, Jos A, Kitashova AA, et al. The exception test for abnormal toxicity as a quality control test: a historical analysis of the data and scientific knowledge. Razrabotka i registratsiya lekarstvennyh sredstv 2015; 2(11): 184–92 (in Russian).
9. FDA [Food and Drug Administration]. 1981b. The Story of The Laws Behind The Labels, Part II: 1938—The Federal Food, Drug, and Cosmetic Act. FDA Consumer, June, 1981. Available from: http://vm.cfsan.fda.gov/~lrd/historla.html.
10. The State Pharmacopoeia of the USSR. 10th ed. Moscow: Meditsina; 1968 (in Russian).
11. U.S.P. 21th edition. 1985.
12. The State Pharmacopoeia of the Russian Federation. 12th ed. Part 1. Moscow: NCESMP; 2008 (in Russian).
13. U.S.P. 22th edition. 1990.
14. The State Pharmacopoeia of the Russian Federation. 13th ed. Part 1. Moscow: NCESMP; 2015 (in Russian).
Review
For citations:
Ryabtseva M.S., Batuashvili T.A., Sapozhnikova G.A., Neugodova N.P., Olefir Yu.V., Merkulov V.A. History and current status of biological tests in Russia. The Bulletin of the Scientific Centre for Expert Evaluation of Medicinal Products. 2016;(1):11-14. (In Russ.)
Views:
762
Email this article 