Optimal sampling methods in pharmacokinetic and pharmacodynamic studies

Abstract

Abstract: Optimal sampling strategies were concerned in many pharmacokinetic and pharmacodynamic researches. The principles, procedures, characteristics and computational methods of D-optimality, limited sampling using multiple linear regression, and limited sampling using maximum a posteriori Bayesian estimation (MAPB) are presented and compared in this review. Several typical application examples of optimal sampling and partial available software are provided in this article.

Key words: Pharmacokinetics, Pharmacodynamics, Optimal sampling, D optimality, Multiple linear regression, Maximum a posteriori Bayesian estimation

CLC Number:

R969.1

LI Yan, SUN He. Optimal sampling methods in pharmacokinetic and pharmacodynamic studies[J]. Chinese Journal of Clinical Pharmacology and Therapeutics, 2012, 17(9): 1014-1021.

References

[1] Aarons L, Ogungbenro K.Optimal design of pharmacokinetic studies[J]. Basic Clin Pharmacol Toxicol, 2010,106(3):250-255.
[2] D'Argenio DZ.Optimal sampling times for pharmacokinetic experiments[J]. J Pharmacokinet Biopharm, 1981,9(6):739-756.
[3] van der Meer AF, Marcus MA, Touw DJ, et al. Optimal sampling strategy development methodology using maximum a posteriori Bayesian estimation[J]. Ther Drug Monit, 2011,33(2):133-146.
[4] Ogungbenro K, Aarons L.Design of population pharmacokinetic experiments using prior information[J]. Xenobiotica, 2007,37(10/11):1311-1330.
[5] Panetta JC, Wilkinson M, Pui CH, et al.Limited and optimal sampling strategies for etoposide and etoposide catechol in children with leukemia[J]. J Pharmacokinet Pharmacodyn, 2002,29(2):171-188.
[6] Delattre IK, Musuamba FT, Nyberg J, et al.Population pharmacokinetic modeling and optimal sampling strategy for Bayesian estimation of amikacin exposure in critically ill septic patients[J]. Ther Drug Monit, 2010,32(6):749-756.
[7] Ding JJ, Jiao Z, Wang Y.Estimation of individual pharmacokinetic parameters using maximum a posteriori Bayesian method with D-optimal sampling strategy[J]. Yao Xue Xue Bao, 2011,46(12):1493-1500.
[8] Saint-Marcoux F, Debord J, Undre N, et al.Pharmacokinetic modeling and development of Bayesian estimators in kidney transplant patients receiving the tacrolimus once-daily formulation[J]. Ther Drug Monit, 2010,32(2):129-135
[9] Overholser BR, Brophy DF, Sowinski KM.Development of an efficient sampling strategy to predict enoxaparin pharmacokinetics in stage 5 chronic kidney disease[J]. Ther Drug Monit, 2006,28(6):807-812.
[10] Bos AM, Boom K, Vinks AA, et al.Development of an optimal sampling strategy for clinical pharmacokinetic studies of the novel anthracycline disaccharide analogue MEN-10755[J]. Cancer Chemother Pharmacol, 2004,54(1):64-70.
[11] Hooker AC, Foracchia M, Dodds MG, et al.An evaluation of population D-optimal designs via pharmacokinetic simulations[J]. Ann Biomed Eng, 2003,31(1):98-111.
[12] Panetta JC, Iacono LC, Adamson PC, et al.The importance of pharmacokinetic limited sampling models for childhood cancer drug development[J]. Clin Cancer Res, 2003,9(14):5068-5077.
[13] Mathew BS, Fleming DH, Annapandian VM, et al.A reliable limited sampling strategy for the estimation of mycophenolic acid area under the concentration time curve in adult renal transplant patients in the stable posttransplant period[J]. Ther Drug Monit, 2010,32(2):136-140.
[14] Chen LF, Jiao JJ, Zhang CL, et al.Bioequivalence assessment of metformin hydrochloride using a limited sampling strategy[J]. Int J Clin Pharmacol Ther, 2011,49(10):629-636.
[15] Cattaneo D, Ripamonti D, Gervasoni C, et al.Limited Sampling Strategies for the Estimation of Raltegravir Daily Exposure in HIV-Infected Patients[J]. J Clin Pharmacol, 2012,52(3):440-445.
[16] Salinger DH, Blough DK, Vicini P, et al.A limited sampling schedule to estimate individual pharmacokinetic parameters of fludarabine in hematopoietic cell transplant patients[J]. Clin Cancer Res, 2009,15(16):5280-5287.
[17] Musuamba FT, Rousseau A, Bosmans JL, et al.Limited sampling models and Bayesian estimation for mycophenolic acid area under the curve prediction in stable renal transplant patients co-medicated with ciclosporin or sirolimus[J]. Clin Pharmacokinet, 2009,48(11):745-758.
[18] van Hasselt JG, Green B, Morrish GA. Leveraging physiological data from literature into a pharmacokinetic model to support informative clinical study design in pregnant women[J]. Pharm Res, 2012,29(6):1609-1617.
[19] Li H, Mager DE, Bemer MJ, et al.A Limited Sampling Schedule to Estimate Mycophenolic Acid Area Under the Concentration-Time Curve in Hematopoietic Cell Transplantation Recipients[J]. J Clin Pharmacol,2011.
[20] Min Y, Qiang F, Peng L, et al.High dose methotrexate population pharmacokinetics and Bayesian estimation in patients with lymphoid malignancy[J]. Biopharm Drug Dispos, 2009,30(8):437-447.
[21] de Winter BC, Neumann I, van Hest RM, et al. Limited sampling strategies for therapeutic drug monitoring of mycophenolate mofetil therapy in patients with autoimmune disease[J].Ther Drug Monit, 2009,31(3):382-390.
[22] Han K, Bies R, Johnson H, et al.Population pharmacokinetic evaluation with external validation and Bayesian estimator of voriconazole in liver transplant recipients[J]. Clin Pharmacokinet, 2011,50(3):201-214.
[23] Engels FK, Loos WJ, van der Bol JM, et al. Therapeutic drug monitoring for the individualization of docetaxel dosing: a randomized pharmacokinetic study[J].Clin Cancer Res, 2011,17(2):353-362.
[24] Tod M, Padoin C, Louchahi K, et al.Application of optimal sampling theory to the determination of metacycline pharmacokinetic parameters: effect of model misspecification[J].J Pharmacokinet Biopharm,1994,22(2):129-146.
[25] Sun H, Ette EI, Ludden TM.On the recording of sample times and parameter estimation from repeated measures pharmacokinetic data[J].J Pharmacokinet Biopharm, 1996,24(6):637-650.
[26] Sheiner LB, Beal SL.Some suggestions for measuring predictive performance[J]. J Pharmacokinet Biopharm,1981,9(4):503-512.
[27] Delaloye JR, Kassir N, Lapeyraque AL, et al.Limited sampling strategies for monitoring tacrolimus in pediatric liver transplant recipients[J]. Ther Drug Monit, 2011,33(4):380-386.
[28] Pawinski T, Kunicki PK, Sobieszczanska-Malek M, et al.A limited sampling strategy for estimating mycophenolic acid area under the curve in adult heart transplant patients treated with concomitant cyclosporine[J]. J Clin Pharm Ther, 2009,34(1):89-101.
[29] Chen LF, Jiao JJ, Zhang CL, et al.Limited sampling strategy to estimate pharmacokinetic parameters of orally administered metformin hydrochloride[J]. Yao Xue Xue Bao,2010,45(12):1533-1536.
[30] Wang K, Sheng YC, He YC, et al.Limited sampling strategy models for estimating AUC for amlodipine in Chinese healthy volunteers[J]. Yao Xue Xue Bao,2010,45(12):1582-1586.
[31] Huang XH, Huang JH, Wang Q, et al.Calculating the pharmacokinetic parameters of cefaclor in healthy volunteers using limited sampling model[J]. Chin J Clin Pharmacol Therapeut, 2012,17(4):421-427.
[32] Wright DF, Duffull SB.Development of a bayesian forecasting method for warfarin dose individualization[J].Pharm Res,2011,28(5):1100-1111.
[33] Al-Khatib M, Shapiro RJ, Partovi N, et al.Limited sampling strategies for predicting area under the concentration-time curve of mycophenolic acid in islet transplant recipients[J]. Ann Pharmacother, 2010,44(1):19-27.
[34] Claeys T, Van Dyck M, Van Damme-Lombaerts R. Pharmacokinetics of tacrolimus in stable paediatric renal transplant recipients[J]. Pediatr Nephrol, 2010,25(2):335-342.
[35] Benkali K, Rostaing L, Premaud A, et al.Population pharmacokinetics and Bayesian estimation of tacrolimus exposure in renal transplant recipients on a new once-daily formulation[J]. Clin Pharmacokinet, 2010,49(10):683-692.
[36] Cattaneo D, Cortinovis M, Baldelli S, et al.Limited sampling strategies for the estimation of sirolimus daily exposure in kidney transplant recipients on a calcineurin inhibitor-free regimen[J]. J Clin Pharmacol, 2009,49(7):773-781.