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<p>TABLEts of lapatinib, a tyrosine kinase inhibitor, are widely used to treat HER2-positive breast cancer. When developing a generic drug, a comparative dissolution kinetics test is performed to study its bioequivalence as related to the original (reference) drug. An evaluation of the study results by the analysis of similarity/dissimilarity factors (<i>f</i><sub>2</sub> and <i>f</i><sub>1</sub>) showed the equivalence of the dissolution profiles of the generic and reference lapatinib tablets in the studied media (quality control medium and buffers with pH 1.2 and 4.5).</p>

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Evaluation of Lapatinib Tablets Equivalence in the Comparative Dissolution Kinetics Test

  • 期刊论文

  • 发表日期：

    2025年1月1日

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  • Z. S. Shprakh,
  • Ya. A. Poskedova,
  • O. L. Orlova,
  • G. V. Ramenskaya

摘要

TABLEts of lapatinib, a tyrosine kinase inhibitor, are widely used to treat HER2-positive breast cancer. When developing a generic drug, a comparative dissolution kinetics test is performed to study its bioequivalence as related to the original (reference) drug. An evaluation of the study results by the analysis of similarity/dissimilarity factors (f2 and f1) showed the equivalence of the dissolution profiles of the generic and reference lapatinib tablets in the studied media (quality control medium and buffers with pH 1.2 and 4.5).