Pharmacokinetic and Pharmacodynamic Modeling and Simulation Analysis of CTB-001, a Recently Developed Generic of Bivalirudin

Purpose CTB-001, a recently developed generic version of bivalirudin, an FDA-approved anticoagulant used for prophylaxis and treatment of cardiovascular diseases, has shown good efficacy and safety in clinical trials. We characterized the pharmacokinetics (PK) and pharmacodynamics (PD) of CTB-001 by...

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Veröffentlicht in:	Pharmaceutical research 2019-10, Vol.36 (10), p.146-9, Article 146
Hauptverfasser:	Han, Sungpil, Kim, Yo-Han, Choi, Hee Youn, Kim, Mi-Jo, Kim, Wan Joo, Park, Hyunjung, Bae, Kyun-Seop, Lim, Hyeong-Seok
Format:	Artikel
Sprache:	eng
Schlagworte:	Adult Agricultural equipment and supplies industry Analysis Anticoagulants Anticoagulants - pharmacokinetics Anticoagulants - pharmacology Biochemistry Biomedical and Life Sciences Biomedical Engineering and Bioengineering Biomedicine Bivalirudin Blood Cardiovascular agents Cardiovascular diseases Clinical trials Computer Simulation Dosage Dose-Response Relationship, Drug Double-Blind Method Drug approval Drug therapy Drugs, Generic Generic drugs Hirudins - pharmacokinetics Hirudins - pharmacology Humans Male Medical colleges Medical examination Medical Law Medical treatment Models, Biological Monte Carlo Method Nafarelin Peptide Fragments - pharmacokinetics Peptide Fragments - pharmacology Pharmacodynamics Pharmacokinetics Pharmacology/Toxicology Pharmacy Prolongation Prophylaxis Prothrombin Prothrombin Time Recombinant Proteins - pharmacokinetics Recombinant Proteins - pharmacology Research Paper Simulation Simulation analysis Simulation methods Thrombin Thromboplastin Treatment Outcome Young Adult
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