A Tribute to Mr. Thomas W. Teal on His Retirement David M. CocchettoRoger W. Croswell Announcement 31 December 2001 Pages: 1043 - 1044
Guest Editor’s Note: Statistical Methodology and Applications in a Regulatory Environment Christy Chuang-Stein EditorialNotes 31 December 2001 Pages: 1045 - 1046
In-Silico Prediction of Drug Properties in Man Using Preclinical Data and Computer-Assisted Drug Development Roberto GomeniChristine FalcozAlan Bye OriginalPaper 31 December 2001 Pages: 1047 - 1063
Optimizing First-Time-In-Human Trial Design for Studying Dose Proportionality Yin YinChao Chen OriginalPaper 31 December 2001 Pages: 1065 - 1078
Designing for Intent-to-Treat Philip William LavoriRee Dawson OriginalPaper 31 December 2001 Pages: 1079 - 1086
Adaptive Designs for Clinical Trials with Highly Successful Treatments Anastasia IvanovaWilliam F. Rosenberger OriginalPaper 31 December 2001 Pages: 1087 - 1093
Flexible Sample Size Considerations Using Information-Based Interim Monitoring Cyrus R. MehtaAnastasios A. Tsiatis OriginalPaper 31 December 2001 Pages: 1095 - 1112
Interim Monitoring of Group Sequential Trials Using Spending Functions for the Type I and Type II Error Probabilities Sandro PampallonaAnastasios A. TsiatisKyungmann Kim OriginalPaper 31 December 2001 Pages: 1113 - 1121
Blinded Sample Size Adjustment David R. BristolLinda Shurzinske OriginalPaper 31 December 2001 Pages: 1123 - 1130
Flexible Interim Analyses in Clinical Trials Using Multistage Adaptive Test Designs Gernot WassmerReinhard EisebittSilke Coburger OriginalPaper 31 December 2001 Pages: 1131 - 1146
Choice of Control in Clinical Trials—Issues and Implications of ICH-E10 Bernhard HuitfeldtLinda DanielsonKarsten Schmidt OriginalPaper 31 December 2001 Pages: 1147 - 1156
Superiority, Noninferiority, Equivalence, and Bioequivalence—Revisited Girish Aras OriginalPaper 31 December 2001 Pages: 1157 - 1164
Testing Noninferiority of Response Rates for Regulatory Filings Using Transformations Brian L. WiensBoris Iglewicz OriginalPaper 31 December 2001 Pages: 1165 - 1171
A Case Study Demonstrating Superiority of a New Compound over the Gold Standard Erhard Quebe-Fehling OriginalPaper 31 December 2001 Pages: 1173 - 1178
Heart Rate-Specific Reference Ranges for QT-Interval in Beagle Dogs Francois Vandenhende OriginalPaper 31 December 2001 Pages: 1179 - 1188
The Expected Toxicity Rate at the Maximum Tolerated Dose in the Standard Phase I Cancer Clinical Trial Design Seung-Ho KangChul Ahn OriginalPaper 31 December 2001 Pages: 1189 - 1199
Analysis of Data with Imbalance in the Baseline Outcome Variable for Randomized Clinical Trials Lynn WeiJi Zhang OriginalPaper 31 December 2001 Pages: 1201 - 1214
Type I Error Rates from Mixed Effects Model Repeated Measures Versus Fixed Effects Anova with Missing Values Imputed Via Last Observation Carried Forward Craig H. MallinckrodtW. Scott ClarkStacy R. David OriginalPaper 31 December 2001 Pages: 1215 - 1225
Some Practical Considerations and a Crude Formula for Estimating Sample Size for McNemar’s Test Robert G. Lehr OriginalPaper 31 December 2001 Pages: 1227 - 1233
Some Statistical Methods to Differentiate a Treatment Effect for Small Shifts in the Tail of a Distribution Michael StepanavageAditi ShahaneMei Wu OriginalPaper 31 December 2001 Pages: 1235 - 1246
Multiple Testing to Establish Noninferiority of k Treatments with a Reference Based on the Ratio of Two Means Dieter HauschkeMeinhard Kieser OriginalPaper 31 December 2001 Pages: 1247 - 1251
Failure-Time Mixture Models: Yet Another Way to Establish Efficacy Kallappa M. Koti OriginalPaper 31 December 2001 Pages: 1253 - 1260
Statistical Methods for Assessing Stability of Compounds in Whole Blood for Clinical Bioanalysis Robert KringleDavid HoffmanRegina Burton OriginalPaper 31 December 2001 Pages: 1261 - 1270
A Unified Approach for Design and Analysis of Transfer Studies for Analytical Methods Robert KringleRichard Khan-MalekMichel Bauer OriginalPaper 31 December 2001 Pages: 1271 - 1288
Defining Treatment-Emergent Adverse Events with the Medical Dictionary for Regulatory Activities (MedDRA) Mary E. NilssonStephanie C. Koke OriginalPaper 31 December 2001 Pages: 1289 - 1299
A Surveillance Program for Serious Adverse Events During Phase III Drug Development Studies Philip Hougaard OriginalPaper 31 December 2001 Pages: 1301 - 1314
Guest Editor’s Note: Annual Fda/Industry Workshop: Statistically Sound Decision Making Greg CampbellSandy Heft EditorialNotes 31 December 2001 Pages: 1315 - 1315
Evaluating Data from Closely Related Clinical Trials Steven SunRam Suresh OriginalPaper 31 December 2001 Pages: 1317 - 1326
Bootstrap Inference for Local Populations Clifford E. Lunneborg OriginalPaper 31 December 2001 Pages: 1327 - 1342
Stratification Issues with Binary Endpoints Devan V. Mehrotra OriginalPaper 31 December 2001 Pages: 1343 - 1350
Compliance as an Explanatory Variable in Hepatitis-C Carmen MakSamuel M. HeftMei-Hsiu Ling OriginalPaper 31 December 2001 Pages: 1351 - 1361
Missing Data Methods in HIV Clinical Trials: Regulatory Guidance And Alternative Approaches Thomas KelleherAlexandra ThiryAnne Cross OriginalPaper 31 December 2001 Pages: 1363 - 1371
Optimal Design of Dose Response Experiments: A Model-Oriented Approach Valerii V. FedorovSergei L. Leonov OriginalPaper 31 December 2001 Pages: 1373 - 1383
Guest Editor’s Note: Dia Workshop on Statistical Methodology in Clinical R&D Meinhard Kieser EditorialNotes 31 December 2001 Pages: 1385 - 1386
Predicting the Duration of Sequential Survival Studies John Whitehead OriginalPaper 31 December 2001 Pages: 1387 - 1400
Sample Size Adjustment in Clinical Trials for Proving Equivalence Tim FriedeMeinhard Kieser OriginalPaper 31 December 2001 Pages: 1401 - 1408
Sample Size Reestimation in Clinical Trials Zhenming Shun OriginalPaper 31 December 2001 Pages: 1409 - 1422
Clinical Trials with an Adaptive Choice of Hypotheses Gerhard HommelSiegfried Kropf OriginalPaper 31 December 2001 Pages: 1423 - 1429
The Jackknife and Bootstrap in Biomedical Research—Common Principles and Possible Pitfalls Iris Pigeot OriginalPaper 31 December 2001 Pages: 1431 - 1443
The Bootstrap Percentile in Food and Drug Administration Regulations for Bioequivalence Assessment Iris Pigeot OriginalPaper 31 December 2001 Pages: 1445 - 1453
The Design and Analysis of Stochastic Cost-Effectiveness Studies for the Evaluation of Health Care Interventions Andrew BriggsMagnus Tambour OriginalPaper 31 December 2001 Pages: 1455 - 1468
Methods for Assessing the Credibility of Clinical Trial Outcomes Robert A. J. Matthews OriginalPaper 31 December 2001 Pages: 1469 - 1478
Individual Therapy: New Dawn or False Dawn? Stephen Senn OriginalPaper 31 December 2001 Pages: 1479 - 1494
A Note on Therapeutic Equivalence and Therapeutic Ratio with Application to Studies in Respiratory Diseases Anders Källén OriginalPaper 31 December 2001 Pages: 1495 - 1505
Validity and Interpretation of Meta-Analyses and One Pivotal Study Jürgen Kübler OriginalPaper 31 December 2001 Pages: 1507 - 1515