Publications & Presentations in the therapeutic area :

Direct comparison of two extended half-life PEGylated recombinant FVIII products

Solms A., Shah A., Berntorp E., Tiede A., Iorio A., Linardi C., Ahsman M., Mancuso M. E., Zhivkov T., Lissitchkov T. Direct comparison of two extended half-life PEGylated recombinant FVIII products: a randomized, crossover pharmacokinetic study in patients with severe hemophilia A. Ann. Hematol. 99(11): 2689–2698, 2020 [Link to publication].

Direct comparison of two extended-half-life recombinant FVIII products

Shah A., Solms A., Wiegmann S., Ahsman M., Berntorp E., Tiede A., Iorio A., Mancuso M.E., Zhivkov T., Lissitchkov T. Direct comparison of two extended-half-life recombinant FVIII products: a randomized, crossover pharmacokinetic study in patients with severe hemophilia A. Annals of Hematology: 2035-2044, 2019. [Link to publication]

Favorable Pharmacokinetic Characteristics of Extended ‑ Half ‑ Life Recombinant Factor VIII BAY 94 ‑ 9027

Solms A., Iorio A., Ahsman M. J., Vis P., Shah A., Berntorp E., Garmann D. Favorable Pharmacokinetic Characteristics of Extended ‑ Half ‑ Life Recombinant Factor VIII BAY 94 ‑ 9027 Enable Robust Individual Profiling Using a Population Pharmacokinetic Approach. Clin. Pharmacokinet, 2019. [Link to publication]

Population pharmacokinetic characterization of BAY 81-8973, a full-length recombinant factor VIII

Garmann D., McLeay S., Shah A., Vis P., Maas Enriquez M., Ploeger, B.A.  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. Haemophilia: 528–537, 2017. [Link to publication]

Recombinant Antithrombin (ATryn) to achieve >80% AT activity in pediatric and neonatal ECMO patients

DeJongh J., Streisand J., Todd Tzanetos D., Fanning J. and Drenth H., Recombinant Antithrombin (ATryn) to achieve >80% AT activity in pediatric and neonatal ECMO patients. 26th Annual ELSO Conference.(2015) [Link to publication]

Dose Selection of Antithrombin (Recombinant)

Paidas M.J., Frieling J., de Jongh J., Drenth H.J. and Streisand J., Dose Selection of Antithrombin (Recombinant) for a Phase 3 Trial in Early-Onset Preeclampsia [149], Obstet Gynecol., 125(Suppl 1): 52S., 2015. [Link to publication]

Development of a dosing regimen for recombinant human antithrombin (rhAT) in pregnant patients

DeJongh J., Frieling J., Lowry S., Drenth H. and Finch M., Development of a dosing regimen for recombinant human antithrombin (rhAT) in pregnant patients. 60th Annual Meeting of the Society for Gynecologic Investigation (SGI) (2013) [Link to publication]

Pharmacokinetics of Recombinant Human Antithrombin

Dejongh J., Frieling J., Lowry S. and Drenth H.J., Pharmacokinetics of Recombinant Human Antithrombin in Delivery and Surgery Patients With Hereditary Antithrombin Deficiency, Clin Appl Thromb Hemost, 11: 11, 2013. [Link to publication]

Pharmacokinetic and pharmacodynamic modeling of the novel oral direct factor Xa inhibitor TAK-442

Stringer F., Ploeger B., Scott G., Kawamura M. and Kupfer S., Pharmacokinetic and pharmacodynamic modeling of the novel oral direct factor Xa inhibitor TAK-442. ASCPT (2009).