Estimating and interpreting individual patients' pharmacokinetic profiles in persons with Hemophilia A or B using a population pharmacokinetic approach: communication from the SSC of the ISTH

Iorio, Alfonso, Blanchette, Victor, Blatny, Jan, Collins, Peter ORCID: https://orcid.org/0000-0002-6410-1324, Fischer, Kathelijn and Neufeld, Ellis 2017. Estimating and interpreting individual patients' pharmacokinetic profiles in persons with Hemophilia A or B using a population pharmacokinetic approach: communication from the SSC of the ISTH. Journal of Thrombosis and Haemostatis 15 (12) , pp. 2461-2465. 10.1111/jth.13867

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Abstract

The ISTH SSC on Factor VIII/IX has previously issued guidelines for studies assessing the pharmacokinetics (PK) of factor concentrates [1,2]. They suggested drawing 10 or 11 blood samples over a period of 32-48h or 50-72h, after infusing 25-50 or 50-75 IU/kg, respectively for factor VIII (FVIII) or factor IX (FIX), in cohorts of 12-15 patients with a crossover design. Such PK studies are not ideal for tailoring the treatment of individual patients, mostly for the requirement of several blood samples. Due to broad inter-individual variation, the individual disposition of FVIII and FIX cannot be predicted from morphometric characteristics and average PK parameters, but requires empirical assessment in each individual [3–6]. Previous guidance of this ISTH SSC described the PK methodology for the prediction of individual trough levels of FVIII [7]. The present communication, building on recent advancements in the population PK (PopPK) of FVIII and FIX [8], adds to the former documents.

Item Type:	Article
Date Type:	Publication
Status:	Published
Schools:	Medicine
Publisher:	Wiley-Blackwell
ISSN:	1538-7933
Date of First Compliant Deposit:	26 October 2017
Date of Acceptance:	27 September 2017
Last Modified:	15 Nov 2024 04:00
URI:	https://orca.cardiff.ac.uk/id/eprint/105984

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