Pharmacodynamic analysis of sparse data from concentration- and effect-controlled clinical trials guided by a pilot study. An investigation by simulations

Journal of Pharmaceutical Sciences

Volumn 85, Issue 6, 1996, Pages 600-607

  Fullerton, Terrence ^a   Forrest, Alan ^a   Levy, Gerhard ^a  

^a UNIVERSITY AT BUFFALO   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

DRUG;

ARTICLE; CLINICAL TRIAL; COMPUTER SIMULATION; CONCENTRATION RESPONSE; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DRUG DESIGN; HUMAN; MATHEMATICAL COMPUTING; POPULATION RESEARCH; SAMPLING; SYSTEM ANALYSIS;

CLINICAL TRIALS; COMPUTER SIMULATION; DOSE-RESPONSE RELATIONSHIP, DRUG; HUMANS; MONTE CARLO METHOD; PHARMACOKINETICS; PHARMACOLOGY; PILOT PROJECTS; RANDOMIZED CONTROLLED TRIALS;

EID: 0029890513     PISSN: 00223549     EISSN: None     Source Type: Journal    
DOI: 10.1021/js9504705     Document Type: Article

References (18)

1. Levy, G. In Variability in Drug Therapy: Description, Estimation, and Control; Rowland, M., Sheiner, L. B., Steimer J.-L., Eds; Raven Press: New York, 1985; pp 125-128.
2. Danhof, M. In Topics in Pharmaceutical Sciences 1989; Breimer, M. M., Crommelin, D. J. A., Midha, K. K., Eds; International Pharmaceutical Federation: The Hague, The Netherlands, 1989; Chapter 41.
3. Levy, G.; Ebling, W. F.; Forrest, A. Clin. Pharmacol. Ther. 1994, 56, 1-8.
4. Peck, C. C. Clin. Pharmacol. Ther. 1993, 53, 385-387.
5. Ebling, W. F.; Levy, G. Ann. Pharmacother. 1990, 30, 12-19.
6. Gibaldi, M.; Perrier, D. Pharmacokinetics, 2nd ed.; Marcel Dekker, Inc.: New York, 1982; Chapter 6.
7. Prévost, G. Estimation of a Normal Probability Density Function from Samples Measured with Non-negligible and Non-constant Dispersion; Internal Report, Adersa-Gerbios, 2 avenue du ler mai, F-91120 Palaiseau, 1977.
8. Steimer, J. L., Mallet, A.; Golmard, J.; Boisieux, J. Drug Metab. Rev. 1984, 15, 265-292.
9. Forrest, A.; Hawtoff, J.; Egorin, M. J. Clin. Pharmacol. Ther. 1991, 49, 153.
10. Van Slooten, A.; Forrest, A.; Collins, D. A.; Schentag, J. J. Clin. Pharmacol. Ther. 1992, 51, 160.
11. D'Argenio, D. Z.; Schumitzky, A. Comput. Programs Biomed. 1979, 9, 115-134.
12. D'Argenio, D. Z.; Schumitzky, A. ADAPT II Users Guide; Biomedical Simulations Resource, University of Southern California: Los Angeles, CA, 1992.
13. D'Argenio, D. Z. J. Pharmacokinet. Biopharm. 1981, 9, 739-756.
14. Landaw, E. M. Optimal Experimental Design for Biologic Compartment Systems with Applications to Pharmacokinetics. Ph.D. Dissertation, UCLA, 1980.
15. Forrest A.; Ballow, C. H.; Nix, D. E.; Birmingham, M. C.; Schentag, J. J. Antimicrob. Agents Chemother. 1993, 37, 1065-1072.
16. Dutta, A.; Matsumoto, Y.; Ebling, W. F. J. Pharm. Sci. 1996, 85, 232-239.
17. Shore, R. M.; Fullerton, T.; Forrest, A. Clin. Pharmacol. Ther. 1996, 59, 153.
18. D'Argenio, D. Z.; Schumitzky, A. Comput. Programs Biomed. 1979, 9, 115-134.