Phase III dose selection of marzeptacog alfa (activated) informed by population pharmacokinetic modeling: A novel hemostatic drug
Author:
Affiliation:
1. Department of Pharmaceutical Biosciences Uppsala University Uppsala Sweden
2. Catalyst Biosciences South San Francisco California USA
Publisher
Wiley
Subject
Pharmacology (medical),Modeling and Simulation
Link
https://onlinelibrary.wiley.com/doi/pdf/10.1002/psp4.12872
Reference20 articles.
1. Subcutaneous engineered factor VIIa marzeptacog alfa (activated) in hemophilia with inhibitors: Phase 2 trial of pharmacokinetics, pharmacodynamics, efficacy, and safety
2. Intravenous versus Subcutaneous Drug Administration. Which Do Patients Prefer? A Systematic Review
3. Barriers and perceived limitations to early treatment of hemophilia
4. CarcaoM GoudemandJ.Inhibitors in hemophilia: a primer.5th ed.World Federation of Hemophilia. November 2018 No. 7.
5. FDA.Research C. for D. E. and The Voice of the Patient: A Series of Reports from FDA's Patient‐Focused Drug Development Initiative.2020. Accessed October 7 2022.https://www.fda.gov/industry/prescription‐drug‐user‐fee‐amendments/fda‐led‐patient‐focused‐drug‐development‐pfdd‐public‐meetings
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1. A bispecific antibody approach for the potential prophylactic treatment of inherited bleeding disorders;Nature Cardiovascular Research;2024-02-08
2. Subcutaneous Marzeptacog Alfa (Activated) for On‐Demand Treatment of Bleeding Events in Subjects With Hemophilia A or B With Inhibitors;Clinical Pharmacology & Therapeutics;2024-01-16
3. Efficacy and safety evaluation of eptacog beta (coagulation factor VIIa [recombinant]-jncw) for the treatment of hemophilia A and B with inhibitors;Expert Review of Hematology;2023-09-25
4. Model‐informed pediatric dose selection of marzeptacog alfa (activated): An exposure matching strategy;CPT: Pharmacometrics & Systems Pharmacology;2023-05-02
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