Leveraging physiological data from literature into a pharmacokinetic model to support informative clinical study design in pregnant women

Pharmaceutical Research

Volumn 29, Issue 6, 2012, Pages 1609-1617

  Van Hasselt, J G Coen ^a,d   Green, Bruce ^b,d   Morrish, Glynn A ^b,c  

^a SLOTERVAART HOSPITAL   (Netherlands)

^b Model Answers Pty Ltd   (Australia)

^c Goodness of Fit Pty Ltd   (Australia)

^d UNIVERSITY OF QUEENSLAND   (Australia)

Author keywords

enoxaparin; NONMEM; optimal design; pharmacokinetics; pregnancy

Indexed keywords

BLOOD CLOTTING FACTOR 10A INHIBITOR; ENOXAPARIN;

ACCURACY; ARTICLE; BLOOD LEVEL; BODY WATER; CLINICAL STUDY; CONTROLLED STUDY; CREATININE CLEARANCE; DRUG METABOLISM; FEMALE; HUMAN; INTERMETHOD COMPARISON; MEDICAL LITERATURE; NONBIOLOGICAL MODEL; PHYSIOLOGY; PREDICTIVE VALIDITY; PREGNANCY; PRIORITY JOURNAL; REGRESSION ANALYSIS; SAMPLING; STATISTICAL MODEL;

ANTICOAGULANTS; BLOOD COAGULATION; BLOOD COAGULATION TESTS; BODY WATER; CREATININE; DRUG MONITORING; ENOXAPARIN; FACTOR XA; FEMALE; GESTATIONAL AGE; HUMANS; KIDNEY; MODELS, BIOLOGICAL; NONLINEAR DYNAMICS; PREGNANCY; REPRODUCIBILITY OF RESULTS;

EID: 84862651945     PISSN: 07248741     EISSN: 1573904X     Source Type: Journal    
DOI: 10.1007/s11095-012-0671-2     Document Type: Article

References (30)

1. GD Anderson 2005 Pregnancy-induced changes in pharmacokinetics: a mechanistic-based approach Clin Pharmacokinet 44 989 16176115 10.2165/00003088-200544100-00001 1:CAS:528:DC%2BD2MXhtF2lu77J
2. JM Davison MCB Noble 1981 Serial changes in 24 hour creatinine clearance during normal menstrual cycles and the first trimester of pregnancy Br J Obstet Gynaecol 88 10 17 7459286 10.1111/j.1471-0528.1981.tb00930.x 1:STN:280:DyaL3M7htVekuw%3D%3D
3. M Dawes PK Chowienczyk 2001 Pharmacokinetics in pregnancy Best Pract Res Clin Obstet Gynaecol 15 819 826 11800526 10.1053/beog.2001.0231 1:STN:280:DC%2BD38%2FntlGrug%3D%3D
4. S Duffull T Waterhouse J Eccleston 2005 Some considerations on the design of population pharmacokinetic studies J Pharmacokinet Pharmacodyn 32 441 457 16284917 10.1007/s10928-005-0034-2
5. MA Andrew, et al. 2007 Amoxicillin pharmacokinetics in pregnant women: modeling and simulations of dosage strategies Clin Pharmacol Ther 81 547 56 17329990 10.1038/sj.clpt.6100126 1:CAS:528:DC%2BD2sXkvFymu7k%3D
6. Lebaudy, C. et al. Changes in enoxaparin pharmacokinetics during pregnancy and implications for antithrombotic therapeutic strategy. Clinical Pharmacology & Therapeutics (2008).
7. MA Andrew MF Hebert P Vicini 2008 Physiologically based pharmacokinetic model of midazolam disposition during pregnancy Annual International Conference of the IEEE Engineering in Medicine and Biology Society 2008 5454 7
8. J-F Bergmann S Mouly 2002 Thromboprophylaxis in medical patients: focus on France Semin Thromb Hemost 28 Suppl 3 51 5 12232825 10.1055/s-2002-34077
9. GC Wong 2003 Use of low-molecular-weight heparins in the management of acute coronary artery syndromes and percutaneous coronary intervention JAMA 289 331 342 12525234 10.1001/jama.289.3.331 1:CAS:528:DC%2BD3sXktFentA%3D%3D
10. NS Macklon I Greer 1996 Venous thromboembolic disease in obstetrics and gynaecology: the Scottish experience Scott Med J 41 83 86 8807703 1:STN:280:DyaK28vgtFehtQ%3D%3D
11. I Pabinger B Schneider 1996 Thrombotic risk in hereditary antithrombin III, protein C, or protein S deficiency. A cooperative, retrospective study. Gesellschaft fur Thrombose- und Hamostaseforschung (GTH) Study Group on Natural Inhibitors Arterioscler Thromb Vasc Biol 16 742 8 8640401 10.1161/01.ATV.16.6. 742 1:STN:280:DyaK283jslyjsg%3D%3D
12. PW Friederich, et al. 1996 Frequency of pregnancy-related venous thromboembolism in anticoagulant factor-deficient women: implications for prophylaxis Ann Intern Med 125 955 960 8967705 1:STN:280:DyaK2s%2FptlGgsA%3D%3D
13. J Conard M Horellou P Van Dreden T Lecompte M Samama 1990 Thrombosis and pregnancy in congenital deficiencies in AT III, protein C or protein S: study of 78 women Thromb Haemost 63 319 320 2141957 1:STN:280:DyaK3czgt1Wlsg%3D%3D
14. B Green, et al. 2005 Dosing strategy for enoxaparin in patients with renal impairment presenting with acute coronary syndromes Br J Clin Pharmacol 59 281 90 15752373 10.1111/j.1365-2125.2004.02253.x 1:CAS:528:DC%2BD2MXjtVOgu7s%3D
15. MR Toglia JG Weg 1996 Venous thromboembolism during pregnancy N Engl J Med 335 108 14 8649471 10.1056/NEJM199607113350207 1:STN:280: DyaK283ms1elsA%3D%3D
16. A Frydman 1996 Low-molecular-weight heparins: an overview of their pharmacodynamics, pharmacokinetics and metabolism in humans Haemostasis 26 24 38 8707165 1:CAS:528:DyaK28XislKgurk%3D
17. MHH Ensom MD Stephenson 2004 Pharmacokinetics of low molecular weight heparin and unfractionated heparin in pregnancy J Soc Gynecol Investig 11 377 383 15350250 10.1016/j.jsgi.2004.02.007 1:CAS:528:DC%2BD2cXntlentLk%3D
18. I Greer BJ Hunt 2005 Low molecular weight heparin in pregnancy: current issues Br J Haematol 128 593 601 15725079 10.1111/j.1365-2141.2004.05304.x 1:CAS:528:DC%2BD2MXjtVGqsro%3D
19. HL Casele SA Laifer DA Woelkers R Venkataramanan 1999 Changes in the pharmacokinetics of the low-molecular-weight heparin enoxaparin sodium during pregnancy Am J Obstet Gynecol 181 1113 10561628 10.1016/S0002-9378(99)70091-8 1:CAS:528:DyaK1MXotVait7Y%3D
20. GM Duffus I MacGillivray KJ Dennis 1971 The relationship between baby weight and changes in maternal weight, total body water, plasma volume, electrolytes and proteins and urinary oestriol excretion Int J Obstet Gynaecol 78 97 104 10.1111/j.1471-0528.1971.tb00240.x 1:CAS:528:DyaE3MXlsV2ksro%3D
21. E Forsum A Sadurskis J Wager 1988 Resting metabolic rate and body composition of healthy Swedish women during pregnancy Am J Clin Nutr 47 942 3376909 1:STN:280:DyaL1c3jvVCrsg%3D%3D
22. FE Hytten AM Thomson N Taggart 1966 Total body water in normal pregnancy J Obstet Gynaecol Br Commonwealth 73 553 561 10.1111/j.1471-0528.1966.tb15533.x 1:STN:280:DyaF2s%2FgtlOguw%3D%3D
23. NGJ Pipe, et al. 1979 Changes in fat, fat-free mass and body water in human normal pregnancy Br J Obstet Gynaecol 86 929 940 118770 10.1111/j.1471-0528.1979.tb11240.x 1:CAS:528:DyaL3cXptFymtA%3D%3D
24. JM Davison FE Hytten 1974 Glomerular filtration during and after pregnancy J Obstet Gynaecol Br Commonwealth 81 588 595 10.1111/j.1471-0528.1974. tb00522.x 1:CAS:528:DyaE2cXls1Ojurk%3D
25. GB West JH Brown BJ Enquist 1997 A general model for the origin of allometric scaling laws in biology Science (New York, N.Y.) 276 122 6 10.1126/science.276.5309.122 1:CAS:528:DyaK2sXitl2jtro%3D
26. NHG Holford 1996 A size standard for pharmacokinetics Clin Pharmacokinet 30 329 332 8743333 10.2165/00003088-199630050-00001 1:STN:280: DyaK28zjtVKluw%3D%3D
27. N Ochsenbein-Kolbe M Roos T Gasser R Zimmermann 2007 Cross-sectional study of weight gain and increase in BMI throughout pregnancy Eur J Obstet Gynecol 130 180 186 10.1016/j.ejogrb.2006.03.024
28. SB Duffull MJ Dooley B Green SG Poole CMJ Kirkpatrick 2004 A standard weight descriptor for dose adjustment in the obese patient Clin Pharmacokinet 43 1167 1178 15568893 10.2165/00003088-200443150-00007
29. Beal SL, Boeckman AJ, Sheiner LB. NONMEM user guides. (1988).
30. Duffull SB, Denman N, Eccleston J, Kimko H. WinPOPT User Guide Version 1.2. (2008).