Editor-in-Chief’s Commentary: The Changing Landscape of Drug Companies Stephen P. Spielberg Commentary 30 December 2014 Pages: 412 - 412
Investigators’ Experience With Expedited Safety Reports Prior to the FDA’s Final IND Safety Reporting Rule Judith M. KramerDavid VockSusan Ellenberg Safety Open access 30 December 2014 Pages: 413 - 419
Teratogenic Drugs and Risk Management: An Implementation Assessment John FreemanRobert BwireJay Backstrom Safety 30 December 2014 Pages: 420 - 427
Key Considerations in the Transition to Risk-Based Monitoring Michael J. Rosenberg Safety 30 December 2014 Pages: 428 - 435
Consideration of Factors Affecting the Safety Index in Early Clinical Drug Development Makoto KayamaMamoru Narukawa Safety 30 December 2014 Pages: 436 - 443
A Bayesian Stopping Rule for Sequential Monitoring of Serious Adverse Events Kosuke KashiwabaraYutaka MatsuyamaYasuo Ohashi Safety 30 December 2014 Pages: 444 - 452
Multipopulation Tailoring Clinical Trials: Design, Analysis, and Inference Considerations Brian A. MillenAlex DmitrienkoDominique Williams Clinical Trials 30 December 2014 Pages: 453 - 462
Academic Clinical Trials and Drug Regulations in Japan: Impacts of Introducing the Investigational New Drug System Hisashi UrushiharaKoji Kawakami Clinical Trials 30 December 2014 Pages: 463 - 472
Adaptive Design: Results of 2012 Survey on Perception and Use Caroline Claire MorganSusan HuyckJ. Kyle Wathen Clinical Trials 30 December 2014 Pages: 473 - 481
The Impact of Collaborative and Risk-Sharing Innovation Approaches on Clinical and Regulatory Cycle Times Joseph A. DiMasiJennifer KimKenneth A. Getz Policy 30 December 2014 Pages: 482 - 487
Biopharmaceutical Contact Centers and Combination Products: Results of a Benchmark Survey Susan T. JonesPete GuillotSuzana A. Giffin Medical Communications 30 December 2014 Pages: 488 - 493
Compliance Within Medical Information and the Emergence of a Medical Information–Dedicated Compliance Person: A Benchmarking Survey Lisa ChenHarry Scheld Medical Communications 30 December 2014 Pages: 494 - 497
Interconnectivity of Disparate Nonclinical Data Silos for Drug Discovery and Development Jyotsna KasturiAlan P. BrownJeremy L. Wally Preclinical Studies 30 December 2014 Pages: 498 - 506
Statistical Properties of Large Sample Tests for Dose Content Uniformity Øyvind HolteMatej Horvat Letter to the Editor 30 December 2014 Pages: NP1 - NP2
