Phase III dose selection of marzeptacog alfa (activated) informed by population pharmacokinetic modeling: A novel hemostatic drug-Reference-Cited by-同舟云学术

Phase III dose selection of marzeptacog alfa (activated) informed by population pharmacokinetic modeling: A novel hemostatic drug

Published:2022-10-18 Issue:12 Volume:11 Page:1628-1637
ISSN:2163-8306
Container-title:CPT: Pharmacometrics & Systems Pharmacology
language:en
Short-container-title:CPT Pharmacom & Syst Pharma

Author:

Faraj Alan¹,Knudsen Tom²,Desai Shraddha²,Neuman Linda²,Blouse Grant E.²,Simonsson Ulrika S. H.¹^ORCID

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. 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

2. 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

3. Model‐informed pediatric dose selection of marzeptacog alfa (activated): An exposure matching strategy;CPT: Pharmacometrics & Systems Pharmacology;2023-05-02