Methods for Preclinical Assessment of the Efficacy of Anticancer Medicines <i>in vivo</i> (Review)

INTRODUCTION. The main risk to the clinical translatability of preclinical results for anticancer medicinal products is posed by the difficulty of simulating clinical conditions in an experimental model. With only 5% of product candidates proving clinically effective, the search for new approaches t...

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Main Authors: M. L. Vasyutina, K. V. Lepik, M. S. Istomina, K. A. Levchuk, A. V. Petukhov, E. V. Shchelina, A. E. Ershova, O. N. Demidov, Ya. G. Toropova
Format: Article
Language:Russian
Published: Federal State Budgetary Institution ‘Scientific Centre for Expert Evaluation of Medicinal Products’ of the Ministry of Health of the Russian Federation (FSBI ‘SCEEMP’) 2025-07-01
Series:Регуляторные исследования и экспертиза лекарственных средств
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Online Access:https://www.vedomostincesmp.ru/jour/article/view/655
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author M. L. Vasyutina
K. V. Lepik
M. S. Istomina
K. A. Levchuk
A. V. Petukhov
E. V. Shchelina
A. E. Ershova
O. N. Demidov
Ya. G. Toropova
author_facet M. L. Vasyutina
K. V. Lepik
M. S. Istomina
K. A. Levchuk
A. V. Petukhov
E. V. Shchelina
A. E. Ershova
O. N. Demidov
Ya. G. Toropova
author_sort M. L. Vasyutina
collection DOAJ
description INTRODUCTION. The main risk to the clinical translatability of preclinical results for anticancer medicinal products is posed by the difficulty of simulating clinical conditions in an experimental model. With only 5% of product candidates proving clinically effective, the search for new approaches to the preclinical development of anticancer medicinal products is currently an active area of research in medicine.AIM. This study aimed to provide methodological support for planning experiments with modelling of neoplastic processes through analysis and classification of the methods used in preclinical studies of the efficacy of anticancer medicinal products in vivo.DISCUSSION. This article reviews the development of animal tumour models and the selection of cell lines and their testing for tumourigenicity and viability on a step-by-step basis. According to the study results, imaging systems, vital staining, and fluorescence- and luminescence-based methods can be used to assess the efficacy of anticancer medicinal products in both solid tumour models and haematological malignancy models. The article presents a schematic representation of the main types of mouse cancer models. However, no single animal species is universally suitable for in vivo cancer modelling. Researchers selecting models and considering their advantages and disadvantages should pay special attention to the similarity of disease mechanisms in animal models and humans at the tissue and molecular level, keeping in mind the aims of their research.CONCLUSIONS. The results of this comparative analysis of methods for preclinical efficacy evaluation of anticancer medicinal products are essential for designing experimental studies and ensuring the reliability of the results obtained. Choosing the correct research method will increase the chances of obtaining experimental data that can be successfully translated into clinical practice.
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institution Kabale University
issn 3034-3062
3034-3453
language Russian
publishDate 2025-07-01
publisher Federal State Budgetary Institution ‘Scientific Centre for Expert Evaluation of Medicinal Products’ of the Ministry of Health of the Russian Federation (FSBI ‘SCEEMP’)
record_format Article
series Регуляторные исследования и экспертиза лекарственных средств
spelling doaj-art-aebbba9152264fb5ae1facf77b1a37f82025-08-20T03:57:31ZrusFederal State Budgetary Institution ‘Scientific Centre for Expert Evaluation of Medicinal Products’ of the Ministry of Health of the Russian Federation (FSBI ‘SCEEMP’)Регуляторные исследования и экспертиза лекарственных средств3034-30623034-34532025-07-0115328930010.30895/1991-2919-2025-655497Methods for Preclinical Assessment of the Efficacy of Anticancer Medicines <i>in vivo</i> (Review)M. L. Vasyutina0K. V. Lepik1M. S. Istomina2K. A. Levchuk3A. V. Petukhov4E. V. Shchelina5A. E. Ershova6O. N. Demidov7Ya. G. Toropova8V.A. Almazov National Medical Research CenterR.M. Gorbacheva Research Institute of Pediatric Oncology, Hematology and Transplantation, Academician I.P. Pavlov First St Petersburg State Medical UniversityV.A. Almazov National Medical Research CenterV.A. Almazov National Medical Research CenterV.A. Almazov National Medical Research CenterV.A. Almazov National Medical Research CenterV.A. Almazov National Medical Research Center; Sirius University of Science and TechnologyInstitute of Cytology of the Russian Academy of Sciences; Sirius University of Science and TechnologyV.A. Almazov National Medical Research Center; Institute for Analytical Instrumentation of the Russian Academy of SciencesINTRODUCTION. The main risk to the clinical translatability of preclinical results for anticancer medicinal products is posed by the difficulty of simulating clinical conditions in an experimental model. With only 5% of product candidates proving clinically effective, the search for new approaches to the preclinical development of anticancer medicinal products is currently an active area of research in medicine.AIM. This study aimed to provide methodological support for planning experiments with modelling of neoplastic processes through analysis and classification of the methods used in preclinical studies of the efficacy of anticancer medicinal products in vivo.DISCUSSION. This article reviews the development of animal tumour models and the selection of cell lines and their testing for tumourigenicity and viability on a step-by-step basis. According to the study results, imaging systems, vital staining, and fluorescence- and luminescence-based methods can be used to assess the efficacy of anticancer medicinal products in both solid tumour models and haematological malignancy models. The article presents a schematic representation of the main types of mouse cancer models. However, no single animal species is universally suitable for in vivo cancer modelling. Researchers selecting models and considering their advantages and disadvantages should pay special attention to the similarity of disease mechanisms in animal models and humans at the tissue and molecular level, keeping in mind the aims of their research.CONCLUSIONS. The results of this comparative analysis of methods for preclinical efficacy evaluation of anticancer medicinal products are essential for designing experimental studies and ensuring the reliability of the results obtained. Choosing the correct research method will increase the chances of obtaining experimental data that can be successfully translated into clinical practice.https://www.vedomostincesmp.ru/jour/article/view/655xenograft modelsxenograft<i>in vivo</i> imagingantitumour activityanimal models of cancerpreclinical research
spellingShingle M. L. Vasyutina
K. V. Lepik
M. S. Istomina
K. A. Levchuk
A. V. Petukhov
E. V. Shchelina
A. E. Ershova
O. N. Demidov
Ya. G. Toropova
Methods for Preclinical Assessment of the Efficacy of Anticancer Medicines <i>in vivo</i> (Review)
Регуляторные исследования и экспертиза лекарственных средств
xenograft models
xenograft
<i>in vivo</i> imaging
antitumour activity
animal models of cancer
preclinical research
title Methods for Preclinical Assessment of the Efficacy of Anticancer Medicines <i>in vivo</i> (Review)
title_full Methods for Preclinical Assessment of the Efficacy of Anticancer Medicines <i>in vivo</i> (Review)
title_fullStr Methods for Preclinical Assessment of the Efficacy of Anticancer Medicines <i>in vivo</i> (Review)
title_full_unstemmed Methods for Preclinical Assessment of the Efficacy of Anticancer Medicines <i>in vivo</i> (Review)
title_short Methods for Preclinical Assessment of the Efficacy of Anticancer Medicines <i>in vivo</i> (Review)
title_sort methods for preclinical assessment of the efficacy of anticancer medicines i in vivo i review
topic xenograft models
xenograft
<i>in vivo</i> imaging
antitumour activity
animal models of cancer
preclinical research
url https://www.vedomostincesmp.ru/jour/article/view/655
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