Population pharmacokinetic characterization of BAY 81-8973, a full-length recombinant factor VIII: lessons learned - importance of including samples with factor VIII levels below the quantitation limit
Author:
Affiliation:
1. Bayer AG; Wuppertal Germany
2. Model Answers Pty Ltd; Brisbane Qld Australia
3. Bayer; Whippany NJ USA
4. LAP&P Consultants BV; Leiden The Netherlands
5. Bayer AG; Berlin Germany
Funder
Bayer
Bayer HealthCare
Publisher
Wiley
Subject
Genetics (clinical),Hematology,General Medicine
Link
http://onlinelibrary.wiley.com/wol1/doi/10.1111/hae.13192/fullpdf
Reference21 articles.
1. Break-through bleeding in relation to predicted factor VIII levels in patients receiving prophylactic treatment for severe hemophilia A;Collins;J Thromb Haemost,2009
2. International Prophylaxis Study Group, Pharmacokinetics Expert Working Group. Implications of coagulation factor VIII and IX pharmacokinetics in the prophylactic treatment of haemophilia;Collins;Haemophilia,2011
3. Limited blood sampling for pharmacokinetic dose tailoring of FVIII in the prophylactic treatment of haemophilia A;Bjorkman;Haemophilia,2010
4. Project on Factor VIII/Factor IX Pharmacokinetics of the Factor VIII/Factor IX Scientific and Standardization Committee of the ISTH. Measurement of factor VIII pharmacokinetics in routine clinical practice;Bjorkman;J Thromb Haemost,2013
5. Population pharmacokinetics of recombinant factor VIII: the relationships of pharmacokinetics to age and body weight;Bjorkman;Blood,2012
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1. Predictive performance of pharmacokinetic-guided prophylactic dosing of factor concentrates in hemophilia A and B;Research and Practice in Thrombosis and Haemostasis;2024-03
2. Development and internal validation of a clinical prediction model for individualized dosing of BAY 81-8973, A full-length recombinant factor VIII, in pediatric patients with haemophilia A;Thrombosis Research;2023-12
3. “A personalized limited sampling approach to better estimate terminal half‐life of FVIII concentrates”: Comment from Huang et al.;Journal of Thrombosis and Haemostasis;2022-10
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