Factor VIII Concentrates: Matching What You See With What You Get

Lusher, Jeanne M.

doi:10.1001/jama.1985.03360060104036

Cited by 5 publications

(1 citation statement)

References 10 publications

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“…Measured peak In vivo recovery Declared units/plasma volume Unfortunately, the calculation of in vivo recovery is subject to the following uncertainties: l. The labelled (declared) potency of the Factor VIII concentrate may differ from the actual content ofthe vial: significant discrepancies have been found (Austen et al 1981; Barrowcliffe & Thomas 1981;Lusher 1985;Ratnoff 1986;Rock et al 1985). Since the declared units participate directly in the calculation of in vivo recovery, this is an obvious source of variability.…”

Section: In Vivo Recoverymentioning

confidence: 99%

Clinical Pharmacokinetics of Factor VIII in Patients with Classic Haemophilia

Messori

Longo

Matucci

et al. 1987

Clinical Pharmacokinetics

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Studies of Factor VIII pharmacokinetics in haemophiliacs can be classified into 2 groups depending on whether single-dose or multiple-dose Factor VIII curves are used. This review analyses information published so far in both these areas, with particular emphasis on the choice of appropriate models for pharmacokinetic analysis. Single-dose studies of Factor VIII kinetics have previously used a wide variety of methods for pharmacokinetic analysis (empirical methods of Factor VIII level prediction, graphical techniques for semilog analysis, 1-compartment and 2-compartment models). However, Factor VIII poses unique problems to the pharmacokineticist because decay curves can be either monophasic (monoexponential) or biphasic (biexponential) for unknown reasons, and because Factor VIII concentrations are generally subject to significant assay error. Problems of compartmental analysis that occurred in previous studies are highlighted, and a model-independent non-compartmental approach for analysing Factor VIII curves is proposed. To date, fewer data have been published on multiple-dose kinetics of Factor VIII. From a clinical point of view, repeated-dose regimens are most commonly required in patients undergoing surgery and in patients with severe bleeding. A fairly well defined 'therapeutic window' of optimal Factor VIII plasma concentrations has been identified, particularly in surgical patients. This fact has spurred research aimed at applying to haemophilia patients the pharmacokinetic dosing methods commonly used for therapeutic monitoring of drugs (e.g. Bayesian method for dosage individualization). A few papers have already been published in this field, and this review summarises problems encountered by previous investigators, and evaluates comparatively the pharmacokinetic methods used.

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