A novel LC-MS/MS method for simultaneous estimation of acalabrutinib and its active metabolite acalabrutinib M<sub>27</sub> in human plasma and application to a human pharmacokinetic study
Venkat Rao Valluri, Naresh Kumar Katari, Chirag Khatri, Pankaj Kasar, Srinivasa Rao Polagani, Sreekantha B. Jonnalagadda
Abstract
> 0.99. The entire method validation was carried out as per the USFDA guidelines on bioanalytical method validation and all validation experiment results were found within acceptable limits. Clinical pharmacokinetic study of both the parent drug and its active metabolite was successfully performed on six healthy volunteers under fasting conditions by applying the present method.
Topics & Concepts
Human plasmaChromatographyBioanalysisMetaboliteLiquid chromatography–mass spectrometryChemistryActive metaboliteTandem mass spectrometryMass spectrometryBiochemistryChronic Lymphocytic Leukemia ResearchChronic Myeloid Leukemia TreatmentsPI3K/AKT/mTOR signaling in cancer