Výsledky vyhledávání - "validation of analytical procedures"

Akademický článek

Organisation of the Work of Bioanalytical Laboratories according to the Principles of Good Clinical Laboratory Practice (Review)

Autor: I. S. Giba

Publikováno v: Регуляторные исследования и экспертиза лекарственных средств, Vol 14, Iss 5, Pp 601-611 (2024)

INTRODUCTION. Bioanalytical laboratories in the Russian Federation should follow the requirements of both the Good Laboratory Practices (GLP), when performing tests for non-clinical studies, and the Good Clinical Practices (GCP), when analysing sampl

Externí odkaz: https://doaj.org/article/35539eedc5eb4b2cbe58378232959e4b

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Akademický článek

International Approaches to the Development, Validation, and Change Management of Analytical Procedures (Review)

Autor: A. V. Fetisova, Zh. I. Aladysheva, N. V. Pyatigorskaya, O. A. Zyryanov, M. M. Marshalova

Publikováno v: Регуляторные исследования и экспертиза лекарственных средств, Vol 14, Iss 5, Pp 561-571 (2024)

INTRODUCTION. In 2023, the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) published a new Guideline on Analytical Procedure Development (ICH Q14) and a revised version of the Guideline on Val

Externí odkaz: https://doaj.org/article/b5afa292376e4b0997076f26dad2a5a2

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Akademický článek

Validation of an Analytical Procedure for Evaluating the Biological Activity of a Medicinal Product Based on Tocilizumab and Determination of Acceptance Criteria for Test Results

Autor: Yu. A. Nikonova, S. G. Abbasova, P. E. Kargopolova, O. M. Strizhakova, I. V. Lyagoskin, A. P. Vasilev, A. S. Pershin

Publikováno v: Регуляторные исследования и экспертиза лекарственных средств, Vol 14, Iss 3, Pp 317-329 (2024)

INTRODUCTION. Bioanalytical techniques are characterised by greater variability and lower stability than physicochemical methods because live test systems are inherently labile. Since regulatory standards do not establish a unified approach, the sele

Externí odkaz: https://doaj.org/article/ee387463937542498c2e3d73d9b3ce55

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Akademický článek

Development and validation of an analytical procedure for the determination of residual protein A in active substances of therapeutic monoclonal antibodies

Autor: E. V. Nozdrina, D. A. Mazalev, D. R. Rogozina, S. P. Zhivoderov, I. V. Lyagoskin, R. R. Shukurov

Publikováno v: Биопрепараты: Профилактика, диагностика, лечение, Vol 24, Iss 1, Pp 32-45 (2024)

SCIENTIFIC RELEVANCE. An important quality-control issue for therapeutic monoclonal antibodies (mAbs) is the determination of residual protein A leaching from the carrier during the purification of mAbs by affinity chromatography. However, unrelated

Externí odkaz: https://doaj.org/article/919eb15018b24c609e3b31ce014e3661

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Akademický článek

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