scholarly journals Population Pharmacokinetic‐Pharmacodynamic Modeling of PB2452, a Monoclonal Antibody Fragment Being Developed as a Ticagrelor Reversal Agent, in Healthy Volunteers

2021 ◽  
Author(s):  
Steven J. Kathman ◽  
Jeffery J. Wheeler ◽  
Deepak L. Bhatt ◽  
Susan E. Arnold ◽  
John S. Lee
Keyword(s):  
Monoclonal Antibody ◽  
Healthy Volunteers ◽  
Antibody Fragment ◽  
Pharmacodynamic Modeling ◽  
Population Pharmacokinetic ◽  
Reversal Agent

scholarly journals Population Pharmacokinetic-Pharmacodynamic Modeling of Captopril in Healthy Volunteers

2001 ◽  
Vol 9 (1) ◽  
pp. 37
Author(s):  
So-Young Yi ◽  
Kyun-Seop Bae ◽  
Hyeong-Seok Lim ◽  
Joo-Youn Cho ◽  
Kyung-Sang Yu ◽  
...  
Keyword(s):  
Healthy Volunteers ◽  
Pharmacodynamic Modeling ◽  
Population Pharmacokinetic

Population Pharmacokinetic/Pharmacodynamic Modeling of Clopidogrel in Korean Healthy Volunteers and Stroke Patients

2012 ◽  
Vol 52 (7) ◽  
pp. 985-995 ◽  
Author(s):  
Joomi Lee ◽  
Yangha Hwang ◽  
Wonku Kang ◽  
Sook Jin Seong ◽  
Mi-sun Lim ◽  
...  
Keyword(s):  
Healthy Volunteers ◽  
Pharmacodynamic Modeling ◽  
Population Pharmacokinetic ◽  
Stroke Patients

Population Pharmacokinetic/Pharmacodynamic Modeling of O-Desmethyltramadol in Young and Elderly Healthy Volunteers

Drugs & Aging ◽  
2019 ◽  
Vol 36 (8) ◽  
pp. 747-758
Author(s):  
Sybil Skinner Robertson ◽  
Mohamad Samer Mouksassi ◽  
France Varin
Keyword(s):  
Healthy Volunteers ◽  
Pharmacodynamic Modeling ◽  
Population Pharmacokinetic

scholarly journals DABIGATRAN AND IDARUZIZUMAB. NEW OPPORTUNITIES FOR IMPROVING PATIENT SAFETY

2019 ◽  
pp. 53-61
Author(s):  
N. A. Novikova ◽  
A. N. Volovchenko ◽  
D. A. Parfenov
Keyword(s):  
Monoclonal Antibody ◽  
Clinical Trials ◽  
Clinical Practice ◽  
Oral Anticoagulants ◽  
Medication Use ◽  
Antibody Fragment ◽  
Efficacy And Safety ◽  
Reversal Agent ◽  
Reversal Agents ◽  
Real Clinical Practice

The widespread use of new oral anticoagulants in clinical practice requires improving the safety of medication use, i.e. the use of specific reversal agents, if necessary. Idarucizumab, a humanied monoclonal antibody fragment, is the first reversal agent authorized in our country that binds to dabigatran. Its efficacy and safety have been validated in several clinical trials, and its use gains experience in real clinical practice.

Idarucizumab, a Humanized, Monoclonal Antibody Fragment for Immediate Reversal of Dabigatran

2015 ◽  
Vol 28 (6) ◽  
pp. 548-554 ◽  
Author(s):  
Marta A. Miyares ◽  
Yara Kuyumjian ◽  
Shannon Eaves ◽  
Eliza Dollard
Keyword(s):  
Monoclonal Antibody ◽  
Anticoagulant Activity ◽  
Antibody Fragment ◽  
The United States ◽  
Mesh Term ◽  
Priority Review ◽  
Reversal Agent ◽  
Humanized Monoclonal Antibody ◽  
Pubmed Database ◽  
License Application

Objective: To evaluate the role of idarucizumab, a humanized monoclonal antibody fragment, as a specific reversal agent for the anticoagulant activity of dabigatran and to review the pharmacology, pharmacokinetic properties, efficacy, and safety of this agent. Methods: A literature search was conducted consisting of a PubMed database using the MeSH term idarucizumab and the key word dabigatran antidote. Studies evaluating the pharmacology, pharmacokinetics, safety, and efficacy of idarucizumab for the reversal of the anticoagulant activity of dabigatran were included. Results: Idarucizumab represents a novel treatment option as it is the only humanized, monoclonal antibody fragment that specifically binds to dabigatran. Studies evaluating reversal of dabigatran-induced anticoagulation have demonstrated immediate, complete, and sustained effects with idarucizumab. Idarucizumab did not overcorrect thrombin generation. Additionally, evaluations have shown that dabigatran can be safely reinitiated 24 hours after the administration of idarucizumab. The United States Food and Drug Administration granted priority review for the biologic license application and accelerated approval for idarucizumab. Conclusion: Idarucizumab represents an encouraging development in the reversal of dabigatran. Its novel mechanism of action, pharmacokinetics, tolerability, and lack of thrombotic events contribute positively to its use in patients who experience bleeding or for those who require emergent surgery or procedures.

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