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Population pharmaco...
Population pharmacokinetic modeling for dose setting of nonacog beta pegol (N9-GP), a glycoPEGylated recombinant factor IX.
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Collins, P W (författare)
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Møss, J (författare)
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- Knobe, Karin (författare)
- Lund University,Lunds universitet,Enheten för pediatrisk hematologi,Forskargrupper vid Lunds universitet,Paediatric Hematologic Research Group,Lund University Research Groups
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Groth, A (författare)
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Colberg, T (författare)
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Watson, E (författare)
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(creator_code:org_t)
- Elsevier BV, 2012
- 2012
- Engelska.
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Ingår i: Journal of Thrombosis and Haemostasis. - : Elsevier BV. - 1538-7933 .- 1538-7836. ; 10:11, s. 2305-2312
- Relaterad länk:
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http://www.ncbi.nlm....
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http://dx.doi.org/10...
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https://onlinelibrar...
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https://lup.lub.lu.s...
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https://doi.org/10.1...
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Abstract
Ämnesord
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- Background: nonacog beta pegol (N9-GP) is a glycoPEGylated recombinant factor IX (rFIX) molecule with a prolonged half-life. Objectives: To provide information on potential dose regimens for N9-GP for phase 3 pivotal and surgery trials. Methods: A population pharmacokinetic model was developed from single-dose data derived from the first human dose trial with N9-GP in hemophilia B patients, and was used to extrapolate to steady-state conditions for different N9-GP dose regimens for prophylaxis. The model was also used to compare prophylaxis using N9-GP with standard prophylactic regimens using rFIX or plasma-derived (pd) FIX (40 IU/kg every third day). Plasma activity following dosing with N9-GP, rFIX, and pdFIX for surgery and on-demand treatment of bleeds was also simulated. Results: A linear two-compartmental model best described the pharmacokinetic profiles of N9-GP, rFIX, and pdFIX. A prophylactic regimen of 10 U/kg N9-GP once weekly predicted mean peak and trough levels of 18 and 4.2 U/dL, while 40 U/kg once weekly predicted values of 72 and 17 U/dL, respectively. Standard prophylactic regimens with rFIX and pdFIX predicted mean peak and trough levels of 34 and 3.9 IU/dL for rFIX, and mean values of 43 and 2.1 IU/dL for pdFIX. Additional simulations predicted significantly reduced dosing frequency and factor concentrate consumption for N9-GP versus rFIX and pdFIX for surgery and the treatment of bleeds. Conclusions: N9-GP may allow prophylaxis, surgical dosing regimens, and on-demand treatment of bleeding episodes with less frequent injections and lower factor concentrate consumption; this possibility is being investigated in prospective clinical trials. © 2012 International Society on Thrombosis and Haemostasis.
Ämnesord
- MEDICIN OCH HÄLSOVETENSKAP -- Klinisk medicin -- Kardiologi (hsv//swe)
- MEDICAL AND HEALTH SCIENCES -- Clinical Medicine -- Cardiac and Cardiovascular Systems (hsv//eng)
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