Circadian Variation in QT Interval Demonstrating Assay Sensitivity in a Phase 1 Clinical Trial Peter J. BourdillonFabiana Gordon Biostatistics 30 December 2010 Pages: 1 - 7
Reduction of Variability of Response-Adaptive Designs for Continuous Treatment Responses in Phase 3 Clinical Trials Atonu BiswasRahul Bhattacharya Biostatistics 30 December 2010 Pages: 9 - 19
Rationale for Sponsor-unblinded Phase 1 Trials: Challenging the Double-blind Paradigm Jitendra GanjuClapton Dias Biostatistics 30 December 2010 Pages: 21 - 27
Statistical Computing Environments and the Practice of Statistics in the Biopharmaceutical Industry Alan HopkinsSusan DukeSue Dubman Biostatistics 30 December 2010 Pages: 29 - 42
Leveraging Technology to Increase Efficiency and Quality for Regulatory Submissions Patricia SichortTeresa Booth-Genthe Regulatory Affairs 30 December 2010 Pages: 43 - 48
Standard Operating Procedures (SOPs): How Companies Can Determine Which Documents They Must Put in Place Janet GoughMichael Hamrell Regulatory Affairs 30 December 2010 Pages: 49 - 54
Biogeneric Regulatory Policies in China and India: A Comparison Study Jeffery W. GuiseBenjamin M. Carson Regulatory Affairs 30 December 2010 Pages: 55 - 67
Discussion Based on the Survey Results of Authorities’ Inquiries during NDA Review in Japan Reiko NumazakiKazumi SunamuraYutaka Kawakami Regulatory Affairs 30 December 2010 Pages: 69 - 79
Mentoring in the Pharmaceutical Industry: Developing an Effective Program for a Field-based Medical Team Barb SchreinerJimmy Block Medical Affairs 30 December 2010 Pages: 81 - 86
Issues with Medical Device Spontaneous Reporting and Improvements through MedSun Melissa Ostuni Medical Affairs 30 December 2010 Pages: 87 - 95
Review of Pediatric Drug Development: Concepts and Applications Theresa Allio Book Review 30 December 2010 Pages: 97 - 99