Determination of minimal sampling time points for reliable pharmacokinetic evaluation of recombinant factor VIII - An exploratory population pharmacokinetic analysis in paediatric patients suffering from severe haemophilia

Haemophilia

Volumn 12, Issue SUPPL. 4, 2006, Pages 50-55

  Stass, Heino ^a  

^a BAYER PHARMA AG   (Germany)

Author keywords

Optimal sampling times; Paediatric patients; Pharmacokinetics; Population PK analysis; rFVIII

Indexed keywords

BLOOD CLOTTING FACTOR 8; RECOMBINANT BLOOD CLOTTING FACTOR 8;

ACCURACY; ADOLESCENT; ARTICLE; BLOOD SAMPLING; BOLUS INJECTION; CHILD; CLINICAL ARTICLE; DISEASE SEVERITY; DRUG CLEARANCE; DRUG DISTRIBUTION; HEMOPHILIA A; HUMAN; LEAN BODY WEIGHT; PRIORITY JOURNAL; RELIABILITY; SENSITIVITY ANALYSIS; SINGLE DRUG DOSE;

EID: 33748777952     PISSN: 13518216     EISSN: 13652516     Source Type: Journal    
DOI: 10.1111/j.1365-2516.2006.01334.x     Document Type: Article

References (23)

1. Guideline on the Clinical Investigation of Human Plasma Derived Factor VIII and IX products (CPMP/BPWG/198/95 Rev. 1, Adopted Oct. 2000).
2. Guideline on the Clinical Investigation of Recombinant Factor VIII and IX products (CPMP/BPWG/1561/99).
3. D'Argenio DZ. Optimal sampling times for pharmacokinetic experiments. J Pharmacokinet Biopharm 1981; 9: 739-56.
4. Forrest A, Ballow CH, Nix D, Schentag JJ. A new approach for designing population sparse sampling strategies-applied to ciprofloxacin pharmacokinetics. Clin Pharmacol Ther 1991; 49: 153.
5. Drusano GL, Forrest A, Snyder MJ, Reed MD, Blumer JL. An evaluation of optimal sampling strategy and adaptive study design. Clin Pharmacol Ther 1988; 44: 232-8.
6. Drusano GL, Forrest A, Yuen G, Plaisance K, Leslie J. Optimal sampling theory: Effect of error in a nominal parameter value on bias and precision of parameter estimation. Clin Pharmacol Ther 1994; 34: 967-74.
7. Kushuba ADM, Ballow CH, Forrest A. A development and evaluation of a Bayesian pharmacokinetic estimator and optimal, sparse sampling strategies for ceftazidime. Antimicrob Agents Chemother 1996; 40: 1860-5.
8. Lustig V, Rosing H, van Warmerdam LJC. Limited sampling models for the pharmacokinetics of docetaxel. Clin Drug Invest 1997; 13: 247-54.
9. Reed MD, Yamashita TS, Marx CM, Myers CM, Blumer JL. Pharmacokinetically based propofol dosing strategy for sedation of the critically ill, mechanically ventilated pediatric patient. Crit Care Med 1996; 24: 1473-81.
10. Drusano GL, Forrest A, Plaisance KI, Wade JC. A prospective evaluation of optimal sampling theory in the determination of the steady state pharmacokinetics of piperacillin in febrile neutropenic cancer patients. Clin Pharmacol Ther 1989; 45: 635-41.
11. Tod M, Padoin C, Louchanhi K, Moreau-Tod B, Petitjean O, Perret G. Application of optimal sampling theory to the determination of metacycline pharmacokinetic parameters: Effect of model misspecification. J Pharmacokinet Biopharm 1994; 22: 129-46.
12. Gicard P, Nony P, Erhardtsen E et al. Population pharmacokinetics of recombinant Factor VIIa in volunteers anticoagulated with acenocoumarol. Thromb Haemost 1998; 80: 109-13.
13. Klitgaard T. Application of trial simulation in the design of a clinical study of recombinant factor VIIa in cirrhotic patients with active varicose bleeding. Clin Pharmacol Ther 2004; P40: PI142.
14. Erichsen L, Klitgaard T. Pharmacokinetics of recombinant factor VIIa in adults with hemophilia A - a modeling and simulation approach. Clin Pharmacol Ther 2004; P22: PI78.
15. Overholser BR, Sowinski KM. Optimal sparse sampling times of anti-factor Xa activity following subcutaneous enoxaparin administration in patients with chronic kidney disease. Clin Pharmacol Ther 2004; P40: PI141.
16. Rowland M, Sheiner LB, Stiemer JL, eds. Variability in Drug Therapy: Description, Estimation, and Control. New York: Raven Press, 1985.
17. Barnes C, Lillicrap D, Pazmino-Canizares J, Blanchette VS, Stain AM, Clark D, Hensmen C, Carcao M. Pharmacokinetics of recombinant factor VIII (Konegate-F®) in children and causes of inter-patient pharmacokinetic variability. Haemophilia 2006; 12 (Suppl. 4): 40-49.
18. Beal SL, Sheiner LB. NONMEM Users Guides, NONMEM Project Group. San Francisco, CA: UCSF, 1992.
19. NONMEM Version V level 1.1. Hanover, MD, USA: GloboMax LLC, 1998.
20. Guidance for Industry: Population Pharmacokinetics. http://www.fda.gov/ cder/: US Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER), Center for Biologics Evaluation and Research (CBER), February, 1999.
21. WinNonlin Version 4.1. Mountain View, CA, USA: Pharsight Corporation, 2002.
22. Gabrielson J, Weiner D, eds. Pharmacokinetic and Pharmacodynamic Data Analysis: Concepts and Applications. Stockholm, Sweden: Swedish Pharmaceutical Press, 2000.
23. Bjoerkman S; Berntorp E. Pharmacokinetics of coagulation factors: clinical relevance for patients with hemophilia A. Clin Pharmacokinet 2001; 40: 815-32.