12 research outputs found

    Parametric synthesis of rod spatial vibroisolation system under arbitrarily directed external disturbance

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    A mathematical model of flexible-rod spatial vibroisolating suspension, describing the motion of protected object, is considered. An algorithm is proposed for solving the problem of spatial displacement of the object under the action of static forces applied in an arbitrary direction. The coefficients of stiffness matrix of the suspension are determined depending on the position of static equilibrium. It is demonstrated that, depending on the requirements by varying geometrical parameters of the rods, different dynamic properties of the suspension may be obtained

    Therapeutic and biopharmaceutical assessment of indapamide medications

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    The paper is focussed on the drug release comparison for multisource indapamide medications against the original medication, Arifon retard (1,5 mg; Servier Laboratories, France). The comparative test of dissolution kinetics was performed in three media modelling physiological gastrointestinal conditions: hydrochloric acid solution, pH 1,2; acetate buffer, pH 4,3; and phosphate buffer, pH 6,8. The results of the dissolution kinetics test were compared to those from the comparative therapeutic studies of indapamide medications

    Affinity Capture Elution (ACE) ELISA Method Development and Validation for Novel RPH-104 Drug Immunogenicity Evaluation

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    As the number of therapeutic protein products is growing rapidly, there is a strong need for the development of bioanalytical methods that are easy to perform, specific, sensitive, robust, and affordable. Methods for immunogenicity evaluation of therapeutic proteins take an important place in this field of bioanalytics. The aim of the study was to develop a method for immunogenicity testing of the novel RPH-104 drug using the Affinity Capture Elution (ACE) ELISA technique. RPH-104 is a promising Interleukin-1 (IL-1) inhibitor that is currently undergoing a series of clinical studies, including those on socially significant and orphan diseases. The developed method was validated for assay cut-point, sensitivity, selectivity, drug tolerance, hook effect, specificity, precision, and stability. Method sensitivity was established at 114.9 ng/mL, while low and high positive controls were equal to anti-RPH-104 antibody concentrations of 155 ng/mL and 2500 ng/mL, respectively. Method specificity was confirmed in the presence of the interfering compounds, namely IL-1α, IL-1β, and IL1-Ra. The developed and validated ELISA method was successfully applied to subject samples
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