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:

Garmann D.1,McLeay S.2,Shah A.3,Vis P.4,Maas Enriquez M.1,Ploeger B.A.5

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

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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