References
- American Association of Pharmaceutical Scientists, Food and Drug Administration, American Society of Clinical Pharmacology Therapeutics . Integration of Pharmacodynamics, Pharmacokinetics and Toxicokinetics in Rational Drug Development (in press)
- Byar , D. P. and Corle , D. K. 1977 . Selecting Optimal Treatment in Clinical Trials Using Covariate Information . Journal of Chronic Disease , 30 : 455 – 459 .
- Byar , D. P. and Green , S. B. 1980 . The Choice of Treatment for Cancer Patients Based on Covariate Information: Application of Prostate Cancer . Bulletin of Cancer , 67 : 477 – 490 .
- Holford , N. H. G. and Sheiner , L. B. 1981 . Understanding the Dose-Effect Relationship: Clinical Application of Pharmacokinetic-Pharmacodynamic Models . Clinical Pharmacokinetics , 6 : 429 – 453 .
- Laird , N. M. and Ware , J. H. 1982 . Random-Effects Models for Longitudinal Data . Biometrics , 38 : 963 – 974 .
- Lindstrom , M. J. and Bates , D. M. 1990 . Nonlinear Mixed Effects Models for Repeated Measures Data . Biometrics , 46 : 673 – 687 .
- O'Neill , R. T. 1988 . “ Assessment of Safety ” . In Biopharmaceutical Statistics for Drug Development , Edited by: Peace , K. XX New York : Marcel Dekker .
- Rowland , M. 1991 . Proceedings of the Manchester Conference on New Strategies in Drug Development and Clinical Evaluation: The Population Approach . September 21–23 1991 , Manchester , UK. European Cooperation in Science & Technology . (in press)
- Sanathanan , L. P. , Peck , C. , Temple , R. , Lieberman , R. and Pledger , G. 1991 . Randomization, PK-Controlled Dosing, and Titration: An Integrated Approach for Designing Clinical Trials . Drug Information Journal , 25 : 425 – 431 .
- Sheiner , L. B. , Hashimoto , Y. and Beal , S. L. 1991 . A Simulation Study Comparing Designs for Dose Ranging . Statistics in Medicine , 10 : 303 – 321 .
- Storer , B. E. 1989 . Design and Analysis of Phase I Clinical Trials . Biometrics , 45 : 925 – 937 .
- Ward , J. F. and Nardi , R. V. 1991 . Using Early Drug Development Data to Design Phase III Trials . Drug Information Journal , 25 : 335 – 344 .
- Whiting , B. , Kelman , A. and Grevel , J. 1986 . Population Pharmacokinetics: Theory and Clinical Application . Clinical Pharmacokinetics , 11 : 387 – 401 .