Learning versus confirming in clinical drug development
作者： Lewis B. Sheiner
DOI: 10.1016/S0009-9236(97)90160-0
关键词: Drug industry 、 Clinical trial 、 Drug development 、 MEDLINE 、 Drug 、 Medicine 、 Surgery 、 Intensive care medicine 、 Treatment outcome 、 Research design
摘要:
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sci-hub.se 参考文章(31)
Carl C. Peck, William H. Barr, Leslie Z. Benet, Jerry Collins, Robert E. Desjardins, Daniel E. Furst, John G. Harter, Gerhard Levy, Thomas Ludden, John H. Rodman, Lilly Sanathanan, Jerome J. Schentag, Vinod P. Shah, Lewis B. Sheiner, Jerome P. Skelly, Donald R. Stanski, Robert J. Temple, C. T. Viswanathan, Judi Weissinger, Avraham Yacobi, Opportunities for integration of pharmacokinetics, pharmacodynamics, and toxicokinetics in rational drug development. Pharmaceutical Research. ,vol. 9, pp. 826- 833 ,(1992) , 10.1023/A:1015824110164
Nicholas Holford, Peter Black, Ron Couch, Julia Kennedy, Robin Briant, Theophylline target concentration in severe airways obstruction - 10 or 20 mg/L? A randomised concentration-controlled trial. Clinical Pharmacokinectics. ,vol. 25, pp. 495- 505 ,(1993) , 10.2165/00003088-199325060-00007
B.G. Reigner, P.E.O. Williams, I.H. Patel, J.L. Steimer, C. Peck, P. Van Brummelen, Integration of PK/PD has Improved Recent Roche Drug Development Clinical Pharmacology & Therapeutics. ,vol. 59, pp. 191- 191 ,(1996) , 10.1038/SJ.CLPT.1996.265
Lewis B Sheiner, The intellectual health of clinical drug evaluation Clinical Pharmacology and Therapeutics. ,vol. 50, pp. 4- 9 ,(1991) , 10.1038/CLPT.1991.97
A. Hecht, G. Heinzel, J. Stangier, D.N. Duong, C.A.P.F. Su, PK/PD study of BIBR 363 CL2, a long‐lasting angiotensin II (A‐II) antagonist. Prediction of optimal doses for multiple dosing from single dose results Clinical Pharmacology & Therapeutics. ,vol. 59, pp. 163- 163 ,(1996) , 10.1038/SJ.CLPT.1996.151
Thomas G. Filloon, Estimating the minimum therapeutically effective dose of a compound via regression modelling and percentile estimation. Statistics in Medicine. ,vol. 14, pp. 925- 932 ,(1995) , 10.1002/SIM.4780140911
J. M. Collins, C. K. Grieshaber, B. A. Chabner, Pharmacologically Guided Phase I Clinical Trials Based Upon Preclinical Drug Development Journal of the National Cancer Institute. ,vol. 82, pp. 1321- 1326 ,(1990) , 10.1093/JNCI/82.16.1321
Colleen Kelly, John Rice, Monotone smoothing with application to dose-response curves and the assessment of synergism. Biometrics. ,vol. 46, pp. 1071- 1085 ,(1990) , 10.2307/2532449
Lewis B. Sheiner, Yukiya Hashimoto, Stuart L. Beal, A simulation study comparing designs for dose ranging Statistics in Medicine. ,vol. 10, pp. 303- 321 ,(1991) , 10.1002/SIM.4780100303
Nicholas Holford, Yukiya Hashimoto, Lewis B. Sheiner, Time and theophylline concentration help explain the recovery of peak flow following acute airways obstruction. Population analysis of a randomised concentration controlled trial. Clinical Pharmacokinectics. ,vol. 25, pp. 506- 515 ,(1993) , 10.2165/00003088-199325060-00008