2022 / 04

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DOI: 10.24075/medet.2022.065

REVIEW

Developing the system of state control of drug quality through formation of competence centers in federal laboratories of the Information Center for Expertise, Accounting and Analysis of Circulation of Human Medicinal Products of the Federal Supervisory Agency for Healthcare of Russia

Galeev RR1,2, Lileeva EG2, Ryzhkova EA1, Galeeva EV1,2, Lezhnina NA1,2
About authors

1 Information Center for Expertise, Accounting and Analysis of Circulation of Human Medicinal Products of the Federal Supervisory Agency for Healthcare, Moscow, Russia

2 Yaroslavl State Medical University, Yaroslavl, Russia

Correspondence should be addressed: Elena G. Lileeva
ul. Popova, 24, Yaroslavl, 150010, Russia; ur.xednay@6002aveelile

About paper

Author contribution: Galeev RR — article concept, study planning; Lileeva EG — literature selection and analysis; Ryzhkova EA — data generalization, text writing; Galeeva EV — data collection, data analysis; Lezhnina NA — data interpretation, preparing a draft of the manuscript.

Received: 2022-10-20 Accepted: 2022-11-25 Published online: 2023-02-01
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  1. Galeyev RR. «Sovremennyy podkhod k organizatsii kontrolya kachestva lekarstvennykh sredstv, nakhodyashchikhsya v obrashchenii na territorii Rossiyskoy federatsii». Vestnik Roszdravnadzora. 2017; 2:41–43. Russian.
  2. Galeev R, Ma B, Saveliev A, Arislanov I. Quantitative analysis of injectable drug products using non-invasive wideband Raman Technology. American Pharmaceutical review. 2015; 18:6.
  3. Galeev RR, Semanov DA, Galeeva EV, Falaleeva TS, Aryslanov IR, Saveliev AA, Davletshin RR. Peak window correlation method for drug screening using Raman spectroscopy. Journal of Pharmaceutical and Biomedical Analysis. 2019;163: 9–16.
  4. Krasheninina MP, Medvedevskikh MYu, Il’ina YeV, Galeyev RR. Primeneniye spektrometrii kombinatsionnogo rasseyaniya sveta s tsel’yu kontrolya kachestva lekarstvennykh sredstv, nakhodyashchikhsya v in”yektsionnoy forme. Sb. tezisov dokladov III mezhdunarodnoy nauchnoy konferentsii «Standartnyye obraztsy v izmereniyakh i tekhnologiyakh». Yekaterinburg, 11– 14 sentyabrya 2018; 93–96 s. Russian.
  5. Krasheninina MP, Medvedevskikh MYu, Galeyeva YeV, Galeyev RR. Primeneniye spektrometrii kombinatsionnogo rasseyaniya sveta s tsel’yu kontrolya kachestva lekarstvennykh sredstv, nakhodyashchikhsya v in”yektsionnoy forme. Standartnyye obraztsy. 2019; 15(1):39–53. DOI 10.20915/2077-1177-2019-15-1-39-53. Russian.
  6. Galeev RR, Saveliev AA, Galeeva EV, Falaleeva TS, Aryslanov IR, Semanov DA, Davletshin RR. Application of the normalized relative error distribution analysis for nondestructive quality control of drugs by Raman spectroscopy. Journal of Raman Spectroscopy. 2019; 1–10 с. Russian.
  7. Shalunova NV, Merkulov VA, Komratov AV, Petruchuk YeM, Semenova IS, Volgin AR, Trusov GA. Trebovaniya k kletochnym kul’turam, ispol’zuyemym dlya proizvodstva i kontrolya kachestva immunobiologicheskikh lekarstvennykh preparatov. Vedomosti nauchnogo tsentra ekspertizy sredstv meditsinskogo primeneniya. 2013; 1:28–32. Russian.