Comparison of the recovery and half‐life of a high‐purity factor IX concentrate with those of a factor IX complex concentrate. Factor IX Study Group

Mc, Poon; Aledort, LM; Anderle, K; Kunschak, M; Morfini, Massimo

doi:10.1046/j.1537-2995.1995.35495216081.x

Cited by 34 publications

(26 citation statements)

References 13 publications

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“…3). These data suggest that patient‐specific factors are likely to be, at least in part, responsible for the wide variability in recovery reported in this and previous studies of F IX concentrates and F IX‐containing products 19‐21,23,24 . White et al 19 found a small positive correlation between recovery and patient age and weight.…”

Section: Discussionsupporting

confidence: 54%

Pharmacokinetic analysis of plasma‐derived and recombinant F IX concentrates in previously treated patients with moderate or severe hemophilia B

et al. 2002

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Section: Discussionsupporting

confidence: 54%

Pharmacokinetic analysis of plasma‐derived and recombinant F IX concentrates in previously treated patients with moderate or severe hemophilia B

et al. 2002

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“…A summary of IVR from crossover studies of FVIII [17][18][19][20] and FIX [21][22][23] PK is reported in Table 1.…”

Section: Resultsmentioning

confidence: 99%

Pharmacokinetics of factor VIII and factor IX

Morfini

2003

Haemophilia

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A survey of principal pharmacokinetic (PK) studies on factor VIII (FVIII) and factor IX (FIX) plasma- and rDNA-derived concentrates, analysed by means of the PKRD program, has been performed. Notwithstanding the accurate definition of the study design, released in 1991 by the Scientific and Standardization Committee of the International Society on Thrombosis and Haemostasis (SSC-ISTH), a large variability of PK parameters has been pointed out. In the majority of the PK studies, the size of the population is small. In this situation, a careful individualization of haemophilia therapy is strongly recommended. The tailored prediction of loading and maintenance dosages and the need for strict control of trough FVIII/IX levels are mandatory not only to decrease the risk of bleeds but also to spare financial resources. Recently, the old problem of FVIII assay standardization has again become a concern among physicians, especially after the introduction of B-domain deleted rFVIII concentrate. The discrepancies between the widely used one-stage clotting assay and the chromogenic substrate assay seem to be solved by the introduction of a product-specific laboratory standard.

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“…The more accurate FVIII assay can be achieved using haemophilia A plasma as diluent instead of buffer [45]. Also, Prothrombin Complex Concentrates (PCC) and high-purity Factor IX concentrates have been submitted to PK analysis at the beginning of 1990 [46,47]. A review of PK outcomes of PCC has been presented at ISTH congress of 2007 in Geneva, as reported in Table 2 [48].…”

Section: Dna-recombinant Clotting Factor Concentrates and Their Phmentioning

confidence: 99%

The History of Clotting Factor Concentrates Pharmacokinetics

Morfini¹

2017

JCM

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Clotting factor concentrates (CFCs) underwent tremendous modifications during the last forty years. Plasma-derived concentrates made the replacement therapy feasible not only in the hospital but also at patients’ home by on-demand or prophylactic regimen. Virucidal methods, implemented soon after hepatitis and AIDS outbreak, and purification by Mabs made the plasma-derived concentrates safer and purer. CFCs were considered equivalent to the other drugs and general rules and methods of pharmacokinetics (PK) were applied to their study. After the first attempts by graphical methods and calculation of In Vivo Recovery, compartment and non-compartment methods were applied also to the study of PK of CFCs. The bioequivalence of the new concentrates produced by means of recombinant DNA biotechnology was evaluated in head-to-head PK studies. Since the beginning, the large inter-patient variability of dose/response of replacement therapy was realized. PK allowed tailoring haemophilia therapy and PK driven prophylaxis resulted more cost effective. Unfortunately, the need of several blood samples and logistic difficulties made the PK studies very demanding. Recently, population PK (PopPK) has been applied to the prediction of CFCs dosing by Bayesian methodology. By PopPK also sparse data may allow evaluating the appropriateness of replacement therapy.

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Comparison of the recovery and half‐life of a high‐purity factor IX concentrate with those of a factor IX complex concentrate. Factor IX Study Group

Abstract: The equivalence in pharmacokinetics and bioavailability indicates that the dosage schedule for Immunine should be the same as or very similar to that of Bebulin. The high specific activity of the former, however, allows administration at lower volumes.

Cited by 34 publications

References 13 publications

Pharmacokinetic analysis of plasma‐derived and recombinant F IX concentrates in previously treated patients with moderate or severe hemophilia B

Pharmacokinetic analysis of plasma‐derived and recombinant F IX concentrates in previously treated patients with moderate or severe hemophilia B

Pharmacokinetics of factor VIII and factor IX

The History of Clotting Factor Concentrates Pharmacokinetics

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