Search Results - "Merkulov, A. V."

EXPERIENCE OF STUDY AND POSSIBLE WAYS OF ELIMINATION OF FALSE POSITIVE AND FALSE NEGATIVE RESULTS DURING EXECUTION OF POLYMERASE CHAIN REACTION ON AN EXAMPLE OF JUNIN VIRUS RNA DETECTION by Sizikova, T E, Lebedev, V N, Pantyukhov, V B, Borisevich, S V, Merkulov, V A

“…Experience of study and possible ways of elimination of false positive and false negative results during execution of polymerase chain reaction on an example…”
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Global Pipeline of Innovative Medicinal Products: A Narrative Review by Merkulov, V. A., Yagudina, R. I., Serpik, V. G.

“…SCIENTIFIC RELEVANCE . The rapid expansion of the range of medicines in the global pharmaceutical market determines the importance of periodically reviewing…”
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Regulation for the Translation of Gene and Cell Therapy into Medical Practice in East Asian Countries by Melnikova, E. V., Merkulov, V. A., Merkulova, O. V.

“…SCIENTIFIC RELEVANCE . Currently, the Russian Federation lacks a comprehensive regulatory framework for the use of gene and cell therapy (GCT) products. There…”
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Development of Medicinal Products Based on Gene-Editing Technology: Regulatory Practices by Pokrovsky, N. S., Vodyakova, M. A., Melnikova, E. V., Merkulov, V. A.

“…Somatic cell genome-editing systems are the most recent gene therapy technology to treat patients with monogenic hereditary cancer or HIV. Gene editing allows…”
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Advanced Therapy Medicines Based on Oncolytic Viruses (Part II: Development and Authorisation of IMLYGIC®) by Melnikova, E. V., Rachinskaya, O. A., Merkulov, V. A.

“…The only oncolytic virus-based product authorised in the US and EU—IMLYGIC ® ,   a genetically modified herpes simplex virus type 1 (by BioVex Inc., a…”
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Advanced Therapy Medicines Based on Oncolytic Viruses (Part I: Development and Authorisation of Products in China) by Melnikova, E. V., Rachinskaya, O. A., Merkulov, V. A.

“…One of the promising areas in the development of innovative products for the treatment of cancer is the use of oncolytic (native or genetically modified)…”
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Recommendations for Validation of Automated Viable Cell Counting Methods (Review) by Vodyakova, M. A., Pokrovsky, N. S., Melnikova, E. V., Merkulov, V. A.

“…Introduction. The quality of viable cell-based products (such as biomedical cell products and advanced therapy medicinal products) must be maintained during…”
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FEATURES OF QUALITY CONTROL STRATEGY FOR DRUGS BASED ON VIABLE SKIN CELLS by Rachinskaya, O. A., Melnikova, E. V., Merkulov, V. A.

“…The aim of the study was to research the international experience in quality assurance of the products based on skin cells in order to identify the features of…”
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Features of Preclinical Studies of Cell Therapy Products by E. V. Melnikova, M. D. Khorolsky, O. A. Rachinskaya, V. A. Merkulov

“…Preclinical studies are one of the most important stages in the development of drugs for medical use, including cell therapy products (in accordance with the…”
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Evaluation of Cell Line Identity Using RTCA Profiling for Quality Control of Products Containing Viable Human Cells by Vodyakova, M. A., Rachinskaya, O. A., Pokrovsky, N. S., Semenova, I. S., Melnikova, E. V., Merkulov, V. A.

“…Introduction. Identity is an important quality attribute of products containing viable human cells, to be tested during the quality control. The verification…”
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Clinical trials for cellular therapy products: conclusions reached by foreign regulatory bodies by E. V. Melnikova, O. V. Merkulova, V. A. Merkulov

“…Currently, the problem of adopting viable human cell-based drugs – biomedical cell products (BCPs) – in medical practice in the Russian Federation includes,…”
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Use of Cytogenetic Analysis Methods for Assessing the Quality of Cell Lines in Biomedical Cell Products by Rachinskaya, O. A., Merkulov, V. A.

“…Biomedical cell products (BMCPs) are a new group of biologicals that are based on various cell lines and are used in the treatment of a  wide range of diseases…”
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Comparative Analysis of Approaches to Assess the Quality of Inactivated Influenza Vaccines: Regulatory Requirements in the Russian Federation and European Union by Khantimirova, L. M., Guseva, S. G., Shevtsov, V. A., Merkulov, V. A., Bondarev, V. P.

“…The experience with the influenza pandemic caused by strain A (H1N1) 2009 and the existing gaps in standardizing and evaluating the quality and effectiveness…”
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Comparative Analysis of the Heavy Metal, Aluminum, and Arsenic Contents in Brown Algae of Various Origins by Shchukin, V. M., Kuz’mina, N. E., Erina, A. A., Yashkir, V. A., Merkulov, V. A.

“…The results of measurements of trace element contents in brown algae of the families Laminariales and Fucales of different origins are presented, along with…”
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Development of a Procedure for Identification of Biperiden Hydrochloride with Specificity for Triperiden Hydrochloride by Kuz’mina, N. E., Moiseev, S. V., Krylov, V. I., Kutin, A. A., Yashkir, V. A., Merkulov, V. A.

“…Biperiden hydrochloride, (1 RS )-1-[(1 RS , 2 SR , 4 RS )-bicyclo[2.2.1]hept-5-en-2-yl]-1-phenyl-3-(piperidin-1-yl)prop an-1-ol hydrochloride, is one of the…”
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Whole-Genome Sequencing and Phylogenetic Analysis of Francisella tularensis Vaccine Strain 15 NIIEG by Naryshkina, E. A., Krasnov, Ya. M., Alhova, Zh. V., Badanin, D. V., Osin, A. V., Lyashova, O. Yu, Sayapina, L. V., Bondarev, V. P., Merkulov, V. A., Olefir, Yu. V., Kutyrev, V. V.

“…Objective of the study was to conduct whole-genome sequencing of the vaccine strain Francisella tularensis 15 NIIEG and determine, based on the results, its…”
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Validation of a Method of Measuring Mean Molecular Weight of Dextrans by Diffusion-Ordered Spectroscopy by Moiseev, S. V., Kuz’mina, N. E., Krylov, V. I., Yashkir, V. A., Merkulov, V. A.

“…Amethod for measuring the mean molecular weight of dextrans by diffusion-ordered NMR spectroscopy was developed and validated. This method allows measurements…”
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Analysis of Factors Influencing the Interchangeability of Antiepileptic Drugs by Alyautdin, R. N., Romanov, B. K., Pasternak, E. Yu, Bunyatyan, N. D., Merkulov, V. A.

“…The presence of several generics on the pharmaceutical market makes it possible to create a competitive environment and helps to reduce the costs of drug…”
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Development of a Method for Determining the Amino Acid Composition of the Pharmaceutical Substance “Glatiramer Acetate” by NMR Spectroscopy by Kuz’mina, N. E., Moiseev, S. V., Krylov, V. I., Kutin, A. A., Yashkir, V. A., Merkulov, V. A.

“…The acid hydrolysis procedure for glatiramer acetate was modified and the characteristic signals in the 1 H and 13 C spectra were identified, allowing its…”
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Sterility Testing of Immonobiological Medicinal Products in Russia. Historical Background and Current Requirements by Sukhanova, S. M., Berdnikova, Z. E., Zakharov, N. E., Merkulov, V. A.

“…Sterility is one of the key parameters of biological safety of immunobiological medicinal products. The article traces the history  of the development of…”
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