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Transfer of the “Assay” and “Dissolution” Methods: Comparative Testing and Acceptance Criteria (Review)

  • STRUCTURE OF CHEMICAL COMPOUNDS, METHODS OF ANALYSIS AND PROCESS CONTROL
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Pharmaceutical Chemistry Journal Aims and scope

Transfer of the “Assay” and “Dissolution” analytical methods in most cases is used in comparative testing of samples. A number of practically important question remain relevant. This article addresses comparative testing of samples with transfer of these methods. Potential acceptance criteria – requirements for acceptable difference between results from the sending and receiving laboratories – are presented. Computational formulas for the TOST test are discussed. Data and guidelines important for increasing the reliability of transfer of the “Assay” and “Dissolution” analytical methods are presented.

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Authors and Affiliations

  1. Department for the Registration and Development of New Drugs, IRVIN 2, 13A Kolomenskii Proezd, 115446, Moscow, Russia

    N. A. Épshtein

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  1. N. A. Épshtein
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Correspondence to N. A. Épshtein.

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Translated from Khimiko-Farmatsevticheskii Zhurnal, Vol. 56, No. 1, pp. 39 – 43, January, 2022.

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Épshtein, N.A. Transfer of the “Assay” and “Dissolution” Methods: Comparative Testing and Acceptance Criteria (Review). Pharm Chem J 56, 105–109 (2022). https://doi.org/10.1007/s11094-022-02608-z

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  • DOI: https://doi.org/10.1007/s11094-022-02608-z

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