APPLICATION OF ANALYTICAL QUALITY BY DESIGN APPROACH TO BIOANALYTICAL METHODS - SIMULTANEOUSLY QUANTIFICATION OF ANTIEPILEPTIC DRUGS IN HUMAN SALIVA

Haxhiu Zajmi, Arlinda and Alija, Gjylai and Havziu, Drita and Tonic Ribarska, Jasmina (2020) APPLICATION OF ANALYTICAL QUALITY BY DESIGN APPROACH TO BIOANALYTICAL METHODS - SIMULTANEOUSLY QUANTIFICATION OF ANTIEPILEPTIC DRUGS IN HUMAN SALIVA. ACTA MEDICA BALKANICA, 5 (9-10). pp. 11-24. ISSN 2545-4870

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Abstract

Bioanalytical methods play a significant role in therapeutic drug monitoring (TDM) with the main objective, the implementation of a rational therapy. The obtained results from bioanalytical method should be consistent, reliable and with high quality, in order to apply for therapeutic monitoring in routine clinical practice. Analytical Quality by Design - AQbD is required as an essential tool during the process of development, optimisation, validation and routine application of bioanalytical method. The aim of this paper is to introduce the concept of analytical quality by design (AQbD), in the development of robustness bioanalytical method for simultaneous determination of antiepileptic drugs (lamotrigine, levetiracetam, valproic acid, carbamazepine and its active metabolite carbamazepine-10,11-epoxide) in human saliva. The proposed and validated methods have been successfully applied for determination of those antiepileptic drugs in saliva collected from epileptic patients that are under the therapy. The results and conclusions confirmed that during the development and optimisation of bioanalytical method, the application of AQbD provide better reliability and quality of obtained bioanalytical data. Keywords: bioanalytical methods, analytical quality by design, lamotrigine, antiepileptic drugs, saliva.

Item Type: Article
Subjects: R Medicine > R Medicine (General)
R Medicine > RA Public aspects of medicine
R Medicine > RC Internal medicine
R Medicine > RS Pharmacy and materia medica
Divisions: Faculty of Medicine, Health and Life Sciences > School of Medicine
Depositing User: Unnamed user with email zshi@unite.edu.mk
Date Deposited: 10 Oct 2020 11:13
Last Modified: 10 Oct 2020 11:13
URI: http://eprints.unite.edu.mk/id/eprint/553

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