Document is current
Any future updates will be listed below
-
Authors
Hansson, Anna B.
Wadström, Hjalmar
Eliasson, Erik
Al Shakirchi, Mahasin
de Monestrol, Isabelle
Barclay, Victoria
-
Funding
Funding for this research was provided by:
Karolinska Institute
- License Information
-
More Information
Article History
Received: 11 June 2024
Revised: 26 July 2024
Accepted: 30 July 2024
First Online: 28 August 2024
Declarations
:
: No ethical permit was needed since the method validation was based on eight anonymised leftover plasma samples. This is in agreement with legislation: Biobankslag (2023:38) Svensk författningssamling 2023:2023:38 – Riksdagen, and the Swedish Biobank.Between July 2022 and September 2023, approximately 80 clinical patient samples (plasma and breast milk) were analysed in a therapeutic drug monitoring context at the Medical Unit for Clinical Pharmacology, Karolinska University Hospital, Sweden, according to legislation Hälso- och sjukvårdslagen (2017:30). The Therapeutic Drug Monitoring Laboratory, at the Medical Unit for Clinical Pharmacology, is accredited according to ISO 15189:2022 by SWEDAC, the Swedish accreditation body. No concentrations or other results were presented for these samples but only as production statistics to demonstrate the applicability of the method and its clinical demand.
: The authors declare no conflicts of interest.Isabelle de Monestrol is principal investigator for pharmaceutical studies, has grants for non-pharmaceutical study, and has been member of steering committees and lecturer, all by receiving payment to institution by Vertex.
