Enzyme-Linked Immunosorbent Assay Method Application in the Study of Comparative Pharmacokinetics of Insulin Glargin Preparations

Aims: adaptation and validation of the ELISA method insulin glargine determination for the pharmacokinetic study, practical approval in the biosimilars clinical trial.Materials and methods. Serum insulin glargine determination was measured using a commercial ELISA kit. All tests were run on a Person...

Descripción completa

Guardado en:

Detalles Bibliográficos
Autores principales:	L. N. Shitov, Yu. A. Dzhurko, R. V. Drai, I. E. Makarenko, A. L. Khokhlov, L. A. Khozova, O. V. Afonkina, Yu. A. Sevastyanova, N. A. Vasilenko, A. A. Abramova
Formato:	article
Lenguaje:	RU
Publicado:	Scientific Сentre for Family Health and Human Reproduction Problems 2019
Materias:	insulin glargine elisa biosimilar validation Science Q
Acceso en línea:	https://doaj.org/article/a41eb306288644d4abb8cd179e27d865
Etiquetas:	Agregar Etiqueta Sin Etiquetas, Sea el primero en etiquetar este registro!

id	oai:doaj.org-article:a41eb306288644d4abb8cd179e27d865
record_format	dspace
spelling	oai:doaj.org-article:a41eb306288644d4abb8cd179e27d8652021-11-23T06:14:42ZEnzyme-Linked Immunosorbent Assay Method Application in the Study of Comparative Pharmacokinetics of Insulin Glargin Preparations2541-94202587-959610.29413/ABS.2019-4.1.14https://doaj.org/article/a41eb306288644d4abb8cd179e27d8652019-04-01T00:00:00Zhttps://www.actabiomedica.ru/jour/article/view/1984https://doaj.org/toc/2541-9420https://doaj.org/toc/2587-9596Aims: adaptation and validation of the ELISA method insulin glargine determination for the pharmacokinetic study, practical approval in the biosimilars clinical trial.Materials and methods. Serum insulin glargine determination was measured using a commercial ELISA kit. All tests were run on a Personal LAB machine (Adaltis S.r.l., Rome, Italy) with test systems for measuring the concentration of insulin glargine (Invitron Ltd., United Kingdom); human insulin concentrations were measured in the samples from the study for correction of cross-reactivity. Clinical part of this study included 42 male patients aged 18–65 with diabetes mellitus type 1. This was a double-blind, randomized, crossover clamp study with wash-out period of 7–14 days. Comparisons drugs: Insulin Glargine (glargine) solution for subcutaneous administration, 100 U/ml (GEROPHARM, Russia) and Lantus® (glargine) solution for subcutaneous administration, 100 U/ml (Sanofi-Aventis Deutschland GmbH, Germany).Results. At the stage of the method adaptation the modification of original manufacturer’s method was performed; the full validation of modified analytical method for all parameters (selectivity, specificity, precision of calibration curves, intra- and inter-batch precision and accuracy, carry-over, dilution integrity, stability of solutions, stability in biologic matrix, parallelism) in accordance with regulatory authorities requirements has been done. The primary endpoint for long-acting insulins – AUCins.0-τ was calculated. Insulin Glargine and Lantus® are equivalent based on AUCins.0-τ data (point estimation for ratio of geometric means was 99 %, the confidence intervals for the ratio of the geometric mean for AUCins.0-τ was 81.02–120.62 %, that correspond to acceptance range 80.00–125.00 %).L. N. ShitovYu. A. DzhurkoR. V. DraiI. E. MakarenkoA. L. KhokhlovL. A. KhozovaO. V. AfonkinaYu. A. SevastyanovaN. A. VasilenkoA. A. AbramovaScientific Сentre for Family Health and Human Reproduction Problemsarticleinsulin glargineelisabiosimilarvalidationScienceQRUActa Biomedica Scientifica, Vol 4, Iss 1, Pp 93-101 (2019)
institution	DOAJ
collection	DOAJ
language	RU
topic	insulin glargine elisa biosimilar validation Science Q
spellingShingle	insulin glargine elisa biosimilar validation Science Q L. N. Shitov Yu. A. Dzhurko R. V. Drai I. E. Makarenko A. L. Khokhlov L. A. Khozova O. V. Afonkina Yu. A. Sevastyanova N. A. Vasilenko A. A. Abramova Enzyme-Linked Immunosorbent Assay Method Application in the Study of Comparative Pharmacokinetics of Insulin Glargin Preparations
description	Aims: adaptation and validation of the ELISA method insulin glargine determination for the pharmacokinetic study, practical approval in the biosimilars clinical trial.Materials and methods. Serum insulin glargine determination was measured using a commercial ELISA kit. All tests were run on a Personal LAB machine (Adaltis S.r.l., Rome, Italy) with test systems for measuring the concentration of insulin glargine (Invitron Ltd., United Kingdom); human insulin concentrations were measured in the samples from the study for correction of cross-reactivity. Clinical part of this study included 42 male patients aged 18–65 with diabetes mellitus type 1. This was a double-blind, randomized, crossover clamp study with wash-out period of 7–14 days. Comparisons drugs: Insulin Glargine (glargine) solution for subcutaneous administration, 100 U/ml (GEROPHARM, Russia) and Lantus® (glargine) solution for subcutaneous administration, 100 U/ml (Sanofi-Aventis Deutschland GmbH, Germany).Results. At the stage of the method adaptation the modification of original manufacturer’s method was performed; the full validation of modified analytical method for all parameters (selectivity, specificity, precision of calibration curves, intra- and inter-batch precision and accuracy, carry-over, dilution integrity, stability of solutions, stability in biologic matrix, parallelism) in accordance with regulatory authorities requirements has been done. The primary endpoint for long-acting insulins – AUCins.0-τ was calculated. Insulin Glargine and Lantus® are equivalent based on AUCins.0-τ data (point estimation for ratio of geometric means was 99 %, the confidence intervals for the ratio of the geometric mean for AUCins.0-τ was 81.02–120.62 %, that correspond to acceptance range 80.00–125.00 %).
format	article
author	L. N. Shitov Yu. A. Dzhurko R. V. Drai I. E. Makarenko A. L. Khokhlov L. A. Khozova O. V. Afonkina Yu. A. Sevastyanova N. A. Vasilenko A. A. Abramova
author_facet	L. N. Shitov Yu. A. Dzhurko R. V. Drai I. E. Makarenko A. L. Khokhlov L. A. Khozova O. V. Afonkina Yu. A. Sevastyanova N. A. Vasilenko A. A. Abramova
author_sort	L. N. Shitov
title	Enzyme-Linked Immunosorbent Assay Method Application in the Study of Comparative Pharmacokinetics of Insulin Glargin Preparations
title_short	Enzyme-Linked Immunosorbent Assay Method Application in the Study of Comparative Pharmacokinetics of Insulin Glargin Preparations
title_full	Enzyme-Linked Immunosorbent Assay Method Application in the Study of Comparative Pharmacokinetics of Insulin Glargin Preparations
title_fullStr	Enzyme-Linked Immunosorbent Assay Method Application in the Study of Comparative Pharmacokinetics of Insulin Glargin Preparations
title_full_unstemmed	Enzyme-Linked Immunosorbent Assay Method Application in the Study of Comparative Pharmacokinetics of Insulin Glargin Preparations
title_sort	enzyme-linked immunosorbent assay method application in the study of comparative pharmacokinetics of insulin glargin preparations
publisher	Scientific Сentre for Family Health and Human Reproduction Problems
publishDate	2019
url	https://doaj.org/article/a41eb306288644d4abb8cd179e27d865
work_keys_str_mv	AT lnshitov enzymelinkedimmunosorbentassaymethodapplicationinthestudyofcomparativepharmacokineticsofinsulinglarginpreparations AT yuadzhurko enzymelinkedimmunosorbentassaymethodapplicationinthestudyofcomparativepharmacokineticsofinsulinglarginpreparations AT rvdrai enzymelinkedimmunosorbentassaymethodapplicationinthestudyofcomparativepharmacokineticsofinsulinglarginpreparations AT iemakarenko enzymelinkedimmunosorbentassaymethodapplicationinthestudyofcomparativepharmacokineticsofinsulinglarginpreparations AT alkhokhlov enzymelinkedimmunosorbentassaymethodapplicationinthestudyofcomparativepharmacokineticsofinsulinglarginpreparations AT lakhozova enzymelinkedimmunosorbentassaymethodapplicationinthestudyofcomparativepharmacokineticsofinsulinglarginpreparations AT ovafonkina enzymelinkedimmunosorbentassaymethodapplicationinthestudyofcomparativepharmacokineticsofinsulinglarginpreparations AT yuasevastyanova enzymelinkedimmunosorbentassaymethodapplicationinthestudyofcomparativepharmacokineticsofinsulinglarginpreparations AT navasilenko enzymelinkedimmunosorbentassaymethodapplicationinthestudyofcomparativepharmacokineticsofinsulinglarginpreparations AT aaabramova enzymelinkedimmunosorbentassaymethodapplicationinthestudyofcomparativepharmacokineticsofinsulinglarginpreparations
_version_	1718416966040944640

Enzyme-Linked Immunosorbent Assay Method Application in the Study of Comparative Pharmacokinetics of Insulin Glargin Preparations

Ejemplares similares