Bioanalytical method validation for therapeutic drug monitoring of olaparib in patients with ovarian cancer

Autor: Konrad Lewandowski, Agnieszka Karbownik, Andrzej Czyrski, Hanna Urjasz, Joanna Stanisławiak-Rudowicz, Edmund Grześkowiak, Edyta Szałek
Jazyk: angličtina
Rok vydání: 2024
Předmět:
Zdroj: Acta Poloniae Pharmaceutica, Vol 81, Iss 2, Pp 263-278 (2024)
Druh dokumentu: article
ISSN: 0001-6837
DOI: 10.32383/appdr/188521
Popis: Olaparib, an oral poly-ADP ribose polymerase (PARP) inhibitor, is a relatively new anticancer drug. It is essential to find TDM-guided dosage for better safety and tolerability of patients. However, first, it is important to develop a suitable analytical method to conduct reliable TDM. The aim of the study was the validation of UPLC-MS/MS method for TDM of olaparib in patients with ovarian cancer, with a particular attention to optimization of recovery. The validation of the method under analysis were accomplished by the ICH guidelines. The recovery of olaparib was optimized with the Central Composite Design (CCD). The TDM study was conducted on 10 patients with ovarian cancer treated with olaparib. The method validation was characterized by good precision (CV
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