An alternative method for population pharmacokinetic data analysis under noncompliance

Journal of Pharmacokinetics and Pharmacodynamics

Volumn 35, Issue 2, 2008, Pages 219-233

  Gupta, Pankaj ^a   Hutmacher, Matthew M ^a   Frame, Bill ^a   Miller, Raymond ^a  

^a PFIZER INC   (United States)

Author keywords

Bias; Compliance; Imprecision; Power; Principle of superposition; Type I error

Indexed keywords

ARTICLE; CLINICAL RESEARCH; DATA ANALYSIS; DOSE RESPONSE; DRUG ABSORPTION; DRUG ACCUMULATION; DRUG DOSE REGIMEN; ERROR; MATHEMATICAL ANALYSIS; OUTPATIENT; PATIENT COMPLIANCE; PHARMACOKINETICS; PRIORITY JOURNAL; SIMULATION; STEADY STATE; TREATMENT REFUSAL;

ALGORITHMS; DATA INTERPRETATION, STATISTICAL; DOSE-RESPONSE RELATIONSHIP, DRUG; HUMANS; INTESTINAL ABSORPTION; MODELS, STATISTICAL; PHARMACOKINETICS; POPULATION; TREATMENT REFUSAL;

EID: 43949121767     PISSN: 1567567X     EISSN: None     Source Type: Journal    
DOI: 10.1007/s10928-008-9085-5     Document Type: Article

References (17)

1. Mu S and Ludden TM (2003). Estimation of population pharmacokinetic parameters in the presence of non-compliance. J Pharmacokinet Pharmacodyn 30: 53-81
2. Lim LL (1992). Estimating compliance to study medication from serum drug levels: application to an AIDS clinical trial of zidovudine. Biometrics 48: 619-630
3. Kenna LA, Labbe L, Barrett JS and Pfister M (2005). Modeling and simulation of adherence: approaches and applications in therapeutics. AAPS J 7: E390-E407
4. Vrijens B, Tousset E, Rode R, Bertz R, Mayer S and Urquhart J (2005). Successful projection of the time course of drug concentration in plasma during a 1-year period from electronically compiled dosing-time data used as input to individually parameterized pharmacokinetic models. J Clin Pharmacol 45: 461-467
5. Girard P, Sheiner LB, Kastrissios H and Blaschke TF (1996). Do we need full compliance data for population pharmacokinetic analysis?. J Pharmacokinet Biopharm 24: 265-282
6. Vrijens B and Goetghebeur E (1999). The impact of compliance in pharmacokinetic studies. Stat Methods Med Res 8: 247-62
7. Lu J, Gries JM, Verotta D and Sheiner LB (2001). Selecting reliable pharmacokinetic data for explanatory analyses of clinical trials in the presence of possible noncompliance. J Pharmacokinet Pharmacodyn 28: 343-362
8. Soy D, Beal SL and Sheiner LB (2004). Population one-compartment pharmacokinetic analysis with missing dosage data. Clin Pharmacol Ther 76: 441-451
9. Li J and Nekka F (2007). A pharmacokinetic formalism explicitly integrating the patient drug compliance. J Pharmacokinet Pharmacodyn 34: 115-139
10. Gibaldi M and Perrier D (1982). Prediction of drug concentrations on multiple dosing using the principle of superposition. Pharmacokinetics. Marcel Dekker, New York
11. Beal SL, Sheiner LB (eds) (1989). NONMEM users guides. Icon Development Solutions, Ellicott City, Maryland
12. Wang W, Husan F and Chow SC (1996). The impact of patient compliance on drug concentration profile in multiple doses. Stat Med 15: 659-669
13. Wang W and Ouyang SP (1998). The formulation of the principle of superposition in the presence of non-compliance and its applications in multiple dose pharmacokinetics. J Pharmacokinet Biopharm 26: 457-469
14. Sheiner LB and Beal SL (1985). Pharmacokinetic parameter estimates from several least squares procedures: superiority of extended least squares. J Pharmacokinet Biopharm 13: 185-201
15. Hutmacher MM, Kowalski KG (2003) Evaluation of random sparse sampling designs for a population pharmacokinetic study: assessment of power and bias using simulation. In: Kimko HC, Duffall S (eds) Marcel Dekker, New York
16. Duffull S, Waterhouse T and Eccleston J (2005). Some considerations on the design of population pharmacokinetic studies. J Pharmacokinet Pharmacodyn 32: 441-457
17. Karlsson MO and Sheiner LB (1993). The importance of modeling interoccasion variability in population pharmacokinetic analyses. J Pharmacokinet Biopharm 21: 735-750