Population modelling of the effect of inogatran, at thrombin inhibitor, on ex vivo coagulation time (APTT) in healthy subjects and patients with coronary artery disease

British Journal of Clinical Pharmacology

Volumn 51, Issue 1, 2001, Pages 71-79

  Cullberg, Marie ^a,b   Eriksson, Ulf G ^a,b   Larsson, Marita ^a,b   Karlsson, Mats O ^a,b  

^a ASTRAZENECA R AND D   (Sweden)

^b UPPSALA UNIVERSITY   (Sweden)

Author keywords

Activated partial thromboplastin time; Anticoagulation; APTT; Inogatran; Population pharmacodynamic modelling; Thrombin inhibition

Indexed keywords

ACETYLSALICYLIC ACID; INOGATRAN; PLACEBO; THROMBIN INHIBITOR;

ADULT; ANTICOAGULATION; ARTICLE; CLINICAL TRIAL; CONCENTRATION RESPONSE; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; CORONARY ARTERY DISEASE; CROSSOVER PROCEDURE; DRUG BLOOD LEVEL; FEMALE; HUMAN; HUMAN CELL; HUMAN EXPERIMENT; HUMAN TISSUE; MALE; MULTICENTER STUDY; NORMAL HUMAN; PARTIAL THROMBOPLASTIN TIME; PHASE 1 CLINICAL TRIAL; PHASE 2 CLINICAL TRIAL; POPULATION MODEL; PREDICTION; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; THROMBOSIS PREVENTION;

ADULT; AGED; AGED, 80 AND OVER; ANTICOAGULANTS; CORONARY DISEASE; FEMALE; HEMOSTATICS; HUMANS; INFUSIONS, INTRAVENOUS; MALE; MIDDLE AGED; PARTIAL THROMBOPLASTIN TIME; POPULATION; THROMBIN;

EID: 0035140558     PISSN: 03065251     EISSN: None     Source Type: Journal    
DOI: 10.1046/j.1365-2125.2001.01326.x     Document Type: Article

References (44)

1. Prothrombin and thrombin
2. In vitro effects of inogatran, a selective low molecular weight thrombin inhibitor
3. Laboratory assessment of antithrombotic therapy: What tests and if so why
4. Hirudin in acute myocardial infarction. Safety report from the thrombolysis and thrombin inhibition in myocardial infarction (TIMI) 9A trial
5. Combined administration of aspirin and a specific thrombin inhibitor in man
6. Clinical pharmacology and drug safety: Lessons from hirudin
7. TM, a direct thrombin inhibitor, in humans
8. Randomized trial of intravenous heparin versus recombinant hirudin for acute coronary syndromes
9. A comparison of recombinant hirudin with heparin for the treatment of acute coronary syndromes
10. Initial experience with hirudin and streptokinase in acute myocardial infarction: Results of the thrombolysis in myocardial infarction (TIMI) 6 trial
11. Heparin
12. Effect of 3.2% vs 3.8% sodium citrate concentration on routine coagulation testing
13. Effects of two different doses of hirudin on APTT, determined with eight different reagents
14. An attempt to standardize the APTT for heparin monitoring, using the P.T. ISI/INR system of calibration, Results of a 13 centre study
15. The variations between heparin sensitivity of different lots of activated partial thromboplastin time reagent produced by the same manufacturer
16. Monitoring heparin therapy. APTT results from partial- vs full-draw tubes
17. Effects of hirudin on activated partial thromboplastin time determined with ten different reagents
18. The APTT monitoring of heparin - The ISTH/ICSH Collaborative Study
19. Activated clotting time as an appropriate test to compare heparin and direct thrombin inhibitors such as hirudin or Ro 46-6240 in experimental arterial thrombosis
20. Antithrombotic effects and bleeding time of thrombin inhibitors and warfarin in the rat
21. Use of Hirulog in the Prevention of venous thrombosis after major hip or knee surgery
22. The importance of enzyme inhibition kinetics for the effect of thrombin inhibitors in a rat model of arterial thrombosis
23. Effects of inogatran, a new low-molecular-weight thrombin inhibitor, in rat models of venous and arterial thrombosis, thrombolysis and bleeding time
24. Phase I studies on inogatran, a new selective thrombin inhibitor
25. Thrombin inhibition with inogatran for unstable angina pectoris: Evidence for reactivated ischemia after cessation of short-term treatment
26. A low molecular weight, selective thrombin inhibitor, inogatran, vs heparin, in unstable coronary artery disease in 1209 patients
27. Xpose - An S-PLUS based model building aid for population analysis with NONMEM
28. The importance of modeling interoccasion variability in population pharmacokinetic analyses
29. Building population pharmacokinetic-pharmacodynamic models. I. Models for covariate effects
30. Inability of the activated partial thromboplastin time to predict heparin levels: Time to reassess guidelines for heparin assays
31. Monitoring anticoagulant therapy by activated partial thromboplastin time: Hirudin assessment
32. Monitoring of r-hirudin anticoagulation during cardiopulmonary bypass - Assessment of the whole blood ecarin clotting time
33. A recombinant hirudin (IK-HIR02) in healthy volunteers. I. Effects on coagulation parameters and bleeding time
34. Experimental pharmacology of hirunorm: A novel synthetic peptide thrombin inhibitor
35. Estimating impossible curves using NONMEM
36. Pharmacokinetics and pharmacodynamics of melagatran, a novel synthetic LMW thrombin inhibitor, in patients with acute DVT
37. Clinical pharmacology of intravenously administered recombinant desulfatohirudin (CGP 39393) in healthy volunteers
38. Models of drug action: Experimental design issues
39. Pharmacodynamic and safety results of PEG-hirudin in healthy volunteers
40. Comparison of two APTT methods of monitoring heparin therapy. APTT ratio and heparin response of pooled normal plasma
41. Heparin and the activated PTT. A difference between the in vitro and in vivo effects and implications for the therapeutic range
42. The control of heparin therapy by the activated partial thromboplastin time: Sensitivity of various thromboplastins to heparin
43. Issues of method-specificity and -dependency of blood pressure data: Lack of reporting of methodological specifications