2. Clinical and Medical Evaluation Process

[1]  Toshihiko Morikawa,et al.  Design Issues in Noninferiority/Equivalence Trials , 1999 .

[2]  Masashi Goto,et al.  Power-transformation for ordered categorical data , 1986 .

[3]  J R Goldsmith,et al.  Why dose-response relationships are often non-linear and some consequences. , 1993, Journal of exposure analysis and environmental epidemiology.

[4]  Masashi Goto PROCESS OF STATISTICAL DATA ANALYSIS , 1986 .

[5]  A Agresti,et al.  A review of tests for detecting a monotone dose-response relationship with ordinal response data. , 1997, Statistics in medicine.

[6]  H. Uesaka Dose-response information and logic for dose-selection , 1996 .

[7]  Masashi Goto,et al.  Statistical Approaches to Detecting Dose-Response Relationships , 2000 .

[8]  Kjell A. Doksum,et al.  Empirical Probability Plots and Statistical Inference for Nonlinear Models in the Two-Sample Case , 1974 .

[9]  E. Garbe,et al.  Clinical and statistical issues in therapeutic equivalence trials , 2004, European Journal of Clinical Pharmacology.

[10]  Masashi Goto,et al.  Statistical Approaches to Accepting Foreign Clinical Data , 2000 .

[11]  Weng Kee Wong,et al.  Designing Studies for Dose Response , 1996 .

[12]  H. Akaike,et al.  Information Theory and an Extension of the Maximum Likelihood Principle , 1973 .

[13]  J. Ph,et al.  Dose response studies. II. Analysis and interpretation. , 1995 .

[14]  M. Goto Power-normal distribution and its applications , 1983 .

[15]  R. Prentice A LOG GAMMA MODEL AND ITS MAXIMUM LIKELIHOOD ESTIMATION , 1974 .

[16]  S. Ruberg,et al.  Dose response studies. I. Some design considerations. , 1995, Journal of biopharmaceutical statistics.

[17]  Alan Agresti,et al.  Tutorial in Biostatistics A review of tests for detecting a monotone dose–response relationship with ordinal response data , 1997 .

[18]  Kjell A. Doksum,et al.  Plotting with confidence: Graphical comparisons of two populations , 1976 .

[19]  J Röhmel,et al.  Therapeutic equivalence investigations: statistical considerations. , 1998, Statistics in medicine.

[20]  A Källén,et al.  Dose response studies: how do we make them conclusive? , 1999, Statistics in medicine.

[21]  F. Pukelsheim Optimal Design of Experiments , 1993 .