The importance of modeling interoccasion variability in population pharmacokinetic analyses

Mats O. Karlsson1,2, Lewis B. Sheiner1
1Department of Pharmacy, School of Pharmacy, University of California, San Francisco
2Division of Pharmacokinetics, Faculty of Pharmacy, Uppsala University, Uppsala, Sweden

Tóm tắt

Từ khóa


Tài liệu tham khảo

M. Rowland. Intra-individual variability in pharmacokinetics. In: D. D. Breimer (ed.),Towards Better Safety of Drugs and Pharmaceutical Products, Elsevier, North-Holland, 1980.

A. Grahnen. The impact of time-dependent phenomena on bioequivalence studies. In: D. D. Breimer and P. Speiser (eds.),Topics in Pharmaceutical Sciences, Elsevier, Amsterdam, 1985.

S. L. Beal and L. B. Sheiner.NONMEM Users Guides, NONMEM Project Group UCSF, San Francisco, CA, 1992.

M. Davidian and A. R. Gallant. Smooth nonparametric maximum likelihood estimation for population pharmacokinetics, with application to quinidine.J. Pharmacokin. Biopharm. 20:531–558 (1992).

A. Mallet. A maximum likelihood estimation method for random coefficient regression models.Biometrika 73:645–656 (1986).

A. Schumitzky. Nonparametric EM Algorithms for estimating prior distributions. Technical Report: 90-3, Laboratory of Applied Pharmacokinetics, USC School of Medicine, 1990.

J. W. Mandema, D. Verotta, and L. B. Sheiner. Building population pharmacokinetic-pharmacodynamic models. I. Models for covariate effects.J. Pharmacokin. Biopharm. 20:511–528 (1992).

M. O. Karlsson and U. Bredberg. Bioavailability estimation by semisimultaneous drug administration: A Monte Carlo simulation study.J. Pharmacokin. Biopharm. 18:103–120 (1990).

N. Kaniwa, N. Aoyagi, H. Ogata, and M. Ishii. Application of the NONMEM method to evaluation of the bioavailability of drug products.J. Pharm. Sci. 79:1116–1120 (1990).

D. A. Graves and I. Chang. Application of NONMEM to routine bioavailability data.J. Pharmacokin. Biopharm. 19:485–496 (1991).

P. O. Maitre, M. Buhrer, D. Thompson, and D. R. Stanski. A three-step approach combining bayesian regression and NONMEM population analysis: application to midazolam.J. Pharmacokin. Biopharm. 19:377–384 (1991).

P. A. Soons, H. C. Schoemaker, A. F. Cohen, and D. D. Breimer. Intraindividual variability in nifedipine pharmacokinetics and effects in healthy subjects.J. Clin. Pharmacol. 32:324–331 (1992).