Разработка и регистрация лекарственных средств (Jan 2019)

DETERMINATION OF DARBEPOETIN ALFA IN RABBIT PLASMA BY ELISA

  • M. V. Karlina,
  • N. M. Faustova,
  • O. N. Pozharitskaya,
  • V. M. Kosman,
  • V. G. Makarov,
  • A. N. Shikov

Journal volume & issue
Vol. 0, no. 4
pp. 204 – 210

Abstract

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Method of quantitative determination of darbepoetin alfa in rabbit blood plasma was developed. Quantitative determination was performed by ELISA using commercially available ELISA kits for assay «Erythropoietin ELISA-Best». The method was validated on the following parameters: specificity, linearity, precision, accuracy, and the stability samples. Linear range of methods for determining darbepoetin alfa in the blood plasma of rabbits was 67-2000 pg/mL, the limit of detection - 31 pg/ml. The method can be used for bioequivalence and toxicokinetics studies of drugs of darbepoetin alfa.

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