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Regulation for the Translation of Gene and Cell Therapy into Medical Practice in East Asian Countries

Vedomosti Naučnogo centra èkspertizy sredstv medicinskogo primeneniâ (Online), 2024-02, Vol.14 (1), p.29-41

2024

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Global Pipeline of Innovative Medicinal Products: A Narrative Review

Vedomosti Naučnogo centra èkspertizy sredstv medicinskogo primeneniâ (Online), 2024-02, Vol.14 (1), p.14-28

2024

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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

Žurnal mikrobiologii, ėpidemiologii i immunobiologii, 2015-11 (6), p.78

2015

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Development of Medicinal Products Based on Gene-Editing Technology: Regulatory Practices

Vedomosti Naučnogo centra èkspertizy sredstv medicinskogo primeneniâ (Online), 2023-07, Vol.13 (2-1), p.248-260

2023

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FEATURES OF QUALITY CONTROL STRATEGY FOR DRUGS BASED ON VIABLE SKIN CELLS

Farmaciâ i Farmakologiâ (Pâtigorsk), 2022-01, Vol.10 (6), p.515-524

2022

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Advanced Therapy Medicines Based on Oncolytic Viruses (Part II: Development and Authorisation of IMLYGIC®)

Vedomosti Naučnogo centra èkspertizy sredstv medicinskogo primeneniâ (Online), 2021-12, Vol.11 (4), p.218-227

2021

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Advanced Therapy Medicines Based on Oncolytic Viruses (Part I: Development and Authorisation of Products in China)

Vedomosti Naučnogo centra èkspertizy sredstv medicinskogo primeneniâ (Online), 2021-10, Vol.11 (3), p.148-159

2021

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Features of Preclinical Studies of Cell Therapy Products

Antibiotics and Chemotherapy, 2020-12, Vol.65 (9-10), p.51-63

2020

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Clinical trials for cellular therapy products: conclusions reached by foreign regulatory bodies

Vestnik transplantologii i iskusstvennykh organov, 2020-01, Vol.22 (2), p.139-150

2020

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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

Èpidemiologiâ i vakcinoprofilaktika (Online), 2021-01, Vol.19 (6), p.36-47

2021

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Use of Cytogenetic Analysis Methods for Assessing the Quality of Cell Lines in Biomedical Cell Products

Biopreparaty, 2018-03, Vol.18 (1), p.25-32

2018

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Comparative Analysis of the Heavy Metal, Aluminum, and Arsenic Contents in Brown Algae of Various Origins

Pharmaceutical chemistry journal, 2018-10, Vol.52 (7), p.627-634

2018

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Whole-Genome Sequencing and Phylogenetic Analysis of Francisella tularensis Vaccine Strain 15 NIIEG

Problemy osobo opasnyh infekcij, 2020-07 (2), p.91-97

2020

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Development of a Procedure for Identification of Biperiden Hydrochloride with Specificity for Triperiden Hydrochloride

Pharmaceutical chemistry journal, 2018-03, Vol.51 (12), p.1106-1110

2018

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Validation of a Method of Measuring Mean Molecular Weight of Dextrans by Diffusion-Ordered Spectroscopy

Pharmaceutical chemistry journal, 2017-12, Vol.51 (9), p.829-832

2017

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Development of a Method for Determining the Amino Acid Composition of the Pharmaceutical Substance “Glatiramer Acetate” by NMR Spectroscopy

Pharmaceutical chemistry journal, 2017-06, Vol.51 (3), p.226-229

2017

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Determination of the parameters of molecular-weight distribution of hydroxyethyl starches by diffusion-ordered NMR spectroscopy

Journal of analytical chemistry (New York, N.Y.), 2015-07, Vol.70 (7), p.843-849

2015

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Genome-Editing and Biomedical Cell Products: Current State, Safety and Efficacy

Biopreparaty, 2018-09, Vol.18 (3), p.140-149

2018

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Analysis of Factors Influencing the Interchangeability of Antiepileptic Drugs

Pharmaceutical chemistry journal, 2016-06, Vol.50 (3), p.181-184

2016

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Sterility Testing of Immonobiological Medicinal Products in Russia. Historical Background and Current Requirements

Biopreparaty, 2018-03, Vol.18 (1), p.5-15

2018

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Pharmacopeia Standard Samples and Their Practical Application in the National Drug Standardization System

Pharmaceutical chemistry journal, 2016-08, Vol.50 (4), p.258-261

2016

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Recommendations for Expounding Evaluation of Biological (Specific) Activity of Biotechnological Products in Product Specification Files

Biopreparaty, 2018-09, Vol.18 (3), p.168-174

2018

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Post-approval Variations to Dossiers for Vaccines: Analysis of Regulatory and Methodological Approaches Used in the Russian Federation and Abroad

Vedomosti Naučnogo centra èkspertizy sredstv medicinskogo primeneniâ (Online), 2019-03, Vol.9 (1), p.41-48

2019

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A Family of Seismometers with Capacitive Transducers

Seismic instruments, 2018-09, Vol.54 (5), p.543-550

2018

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PROBLEMS OF IODIDE IONS DETERMINATION IN MULTIVITAMINS BY INDUCTIVELY COUPLED PLASMA ATOMIC-EMISSION SPECTROMETRY

The Bulletin of the Scientific Centre for Expert Evaluation of Medicinal Products, 2018-06, Vol.8 (2), p.128-132

2018

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Regulation for the Translation of Gene and Cell Therapy into Medical Practice in East Asian Countries

Global Pipeline of Innovative Medicinal Products: A Narrative Review

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

Development of Medicinal Products Based on Gene-Editing Technology: Regulatory Practices

FEATURES OF QUALITY CONTROL STRATEGY FOR DRUGS BASED ON VIABLE SKIN CELLS

Advanced Therapy Medicines Based on Oncolytic Viruses (Part II: Development and Authorisation of IMLYGIC®)

Advanced Therapy Medicines Based on Oncolytic Viruses (Part I: Development and Authorisation of Products in China)

Features of Preclinical Studies of Cell Therapy Products

Clinical trials for cellular therapy products: conclusions reached by foreign regulatory bodies

Comparative Analysis of Approaches to Assess the Quality of Inactivated Influenza Vaccines: Regulatory Requirements in the Russian Federation and European Union

Use of Cytogenetic Analysis Methods for Assessing the Quality of Cell Lines in Biomedical Cell Products

Comparative Analysis of the Heavy Metal, Aluminum, and Arsenic Contents in Brown Algae of Various Origins

Whole-Genome Sequencing and Phylogenetic Analysis of Francisella tularensis Vaccine Strain 15 NIIEG

Development of a Procedure for Identification of Biperiden Hydrochloride with Specificity for Triperiden Hydrochloride

Validation of a Method of Measuring Mean Molecular Weight of Dextrans by Diffusion-Ordered Spectroscopy

Development of a Method for Determining the Amino Acid Composition of the Pharmaceutical Substance “Glatiramer Acetate” by NMR Spectroscopy

Determination of the parameters of molecular-weight distribution of hydroxyethyl starches by diffusion-ordered NMR spectroscopy

Genome-Editing and Biomedical Cell Products: Current State, Safety and Efficacy

Analysis of Factors Influencing the Interchangeability of Antiepileptic Drugs

Sterility Testing of Immonobiological Medicinal Products in Russia. Historical Background and Current Requirements

Pharmacopeia Standard Samples and Their Practical Application in the National Drug Standardization System

Recommendations for Expounding Evaluation of Biological (Specific) Activity of Biotechnological Products in Product Specification Files

Post-approval Variations to Dossiers for Vaccines: Analysis of Regulatory and Methodological Approaches Used in the Russian Federation and Abroad

A Family of Seismometers with Capacitive Transducers

PROBLEMS OF IODIDE IONS DETERMINATION IN MULTIVITAMINS BY INDUCTIVELY COUPLED PLASMA ATOMIC-EMISSION SPECTROMETRY

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