Overview and Comparison of Postmarketing Drug Safety Surveillance in Selected Developing and Well-Developed Countries Sampada S. VaidyaJeff Jianfei Guo BpharmMichael Steinbuch Pharmacovigilance 30 December 2010 Pages: 519 - 533
Survey of Medical Liaison Practices 3: Assessing Practice Trends across the Pharmaceutical Industry J. Lynn BassChristopher M. MarroneCraig Klinger Drug Information 30 December 2010 Pages: 535 - 549
Medical Liaison Survey 4: Assessing Tools Used by Medical Liaisons, Clinical Trial Involvement, and Career Strategies Craig J. KlingerChristopher M. MarroneJ. Lynn Bass Drug Information 30 December 2010 Pages: 551 - 567
Pharmaceutical Medical Information Contact Centers: Results of Three Benchmarking Surveys Pete GuillotStacey M. Fung Drug Information 30 December 2010 Pages: 569 - 579
Statistical Considerations for the Efficacy Assessment of Clinical Studies of Vulvar and Vaginal Atrophy Ling ChenMoh-Jee NgAnthony Orencia Biostatistics 30 December 2010 Pages: 581 - 588
Statistical Inference after an Adaptive Group Sequential Design: A Case Study Lothar T. Tremmel Biostatistics 30 December 2010 Pages: 589 - 598
Blinded Sample Size Recalculation in Noninferiority Trials: A Case Study in Dermatology Tim FriedeHolger Stammer Biostatistics 30 December 2010 Pages: 599 - 607
Nonparametric Sample Size Estimation for Sensitivity and Specificity with Multiple Observations per Subject Fan HuWilliam R. SchucanyChul Ahn Biostatistics 30 December 2010 Pages: 609 - 616
Assessment of Consistency of Treatment Effects in Multiregional Clinical Trials Hui QuanMingyu LiKimitoshi Ikeda Biostatistics 30 December 2010 Pages: 617 - 632
A Snapshot of the Evolution of Pharmaceutical Regulations in China and Hong Kong Bing Bing Lin Regulatory Affairs 30 December 2010 Pages: 633 - 639
Understanding the Differences and Effectively Transitioning between the US Integrated Summaries of Effectiveness and Safety (ISE/ISS) and the CTD Summaries of Clinical Efficacy and Safety (SCE/SCS) David N. SchwartzMichael J. UmenMary Vanderhoof Regulatory Affairs 30 December 2010 Pages: 641 - 648