Opportunities for Filling Gaps in Breast and Lung Cancer Outcomes Research Jon C. SchommerJose William CastellanosXin Ye Research 30 December 2005 Pages: 335 - 344
An Academic ECG Core Lab Perspective of the FDA Initiative for Digital ECG Capture and Data Management in Large-Scale Clinical Trials Per JohansonPaul W. ArmstrongGalen S. Wagner Clinical Trials 30 December 2005 Pages: 345 - 351
A Note on Power and Sampling Schedule in Population Pharmacokinetic Studies Mamoru NarukawaAkifumi Yafune Statistics 30 December 2005 Pages: 353 - 360
The Cluster Design for the Postmarketing Stability Surveillance Program F. VerbonE. van den HeuvelC. van den Vermaat Statistics 30 December 2005 Pages: 361 - 371
A Note on Postrandomization Adjustment of Covariates Xun ChenMinzhi LiuJi Zhang Statistics 30 December 2005 Pages: 373 - 383
The Importance of QT/QTc Prolongation: A Case Study Marilyn A. Agin QT / QTc Interval Prolongation 30 December 2005 Pages: 385 - 386
ICH E14: A New Regulatory Guidance on the Clinical Evaluation of QT/QTc Internal Prolongation and Proarrhythmic Potential for Non-antiarrhythmic Drugs Philip T. SagerThierry NeboutBorje Darpo QT / QTc Interval Prolongation 30 December 2005 Pages: 387 - 394
Electrocardiogram Reference Ranges Derived from a Standardized Clinical Trial Population Alexei A. DmitrienkeGregory D. SidesPaul R. Eisenberg QT / QTc Interval Prolongation 30 December 2005 Pages: 395 - 405
The Assessment of QT/QTc Interval Prolongation in Clinical Trials: A Regulatory Perspective Colette Strnadova QT / QTc Interval Prolongation 30 December 2005 Pages: 407 - 435
Modeling and Interpreting QTc Prolongation in Clinical Pharmacology Studies Scott D. PattersonByron JonesNévine Zariffa QT / QTc Interval Prolongation 30 December 2005 Pages: 437 - 445
A Simulation Study of Power in Thorough QT/QTc Studies and a Normal Approximation for Planning Purposes Balakrishna HosmaneCharles Locke QT / QTc Interval Prolongation 30 December 2005 Pages: 447 - 455
International Conference on Natural Health Products: “Promotion and Development of Botanicals with International Coordination: Exploring Quality, Safety, Efficacy, and Regulations” Pulok K. Mukherjee Proceedings 30 December 2005 Pages: 457 - 463