1. Editor-in-Chief’s Commentary: The Changing Landscape of Drug Companies

   • Stephen P. Spielberg

   Commentary 30 December 2014 Pages: 412 - 412

2. Investigators’ Experience With Expedited Safety Reports Prior to the FDA’s Final IND Safety Reporting Rule

   • Judith M. Kramer
   • David Vock
   • Susan Ellenberg

   Safety Open access 30 December 2014 Pages: 413 - 419

3. Teratogenic Drugs and Risk Management: An Implementation Assessment

   • John Freeman
   • Robert Bwire
   • Jay Backstrom

   Safety 30 December 2014 Pages: 420 - 427

4. Key Considerations in the Transition to Risk-Based Monitoring

   • Michael J. Rosenberg

   Safety 30 December 2014 Pages: 428 - 435

5. Consideration of Factors Affecting the Safety Index in Early Clinical Drug Development

   • Makoto Kayama
   • Mamoru Narukawa

   Safety 30 December 2014 Pages: 436 - 443

6. A Bayesian Stopping Rule for Sequential Monitoring of Serious Adverse Events

   • Kosuke Kashiwabara
   • Yutaka Matsuyama
   • Yasuo Ohashi

   Safety 30 December 2014 Pages: 444 - 452

7. Multipopulation Tailoring Clinical Trials: Design, Analysis, and Inference Considerations

   • Brian A. Millen
   • Alex Dmitrienko
   • Dominique Williams

   Clinical Trials 30 December 2014 Pages: 453 - 462

8. Academic Clinical Trials and Drug Regulations in Japan: Impacts of Introducing the Investigational New Drug System

   • Hisashi Urushihara
   • Koji Kawakami

   Clinical Trials 30 December 2014 Pages: 463 - 472

9. Adaptive Design: Results of 2012 Survey on Perception and Use

   • Caroline Claire Morgan
   • Susan Huyck
   • J. Kyle Wathen

   Clinical Trials 30 December 2014 Pages: 473 - 481

10. The Impact of Collaborative and Risk-Sharing Innovation Approaches on Clinical and Regulatory Cycle Times

    • Joseph A. DiMasi
    • Jennifer Kim
    • Kenneth A. Getz

    Policy 30 December 2014 Pages: 482 - 487

11. Biopharmaceutical Contact Centers and Combination Products: Results of a Benchmark Survey

    • Susan T. Jones
    • Pete Guillot
    • Suzana A. Giffin

    Medical Communications 30 December 2014 Pages: 488 - 493

12. Compliance Within Medical Information and the Emergence of a Medical Information–Dedicated Compliance Person: A Benchmarking Survey

    • Lisa Chen
    • Harry Scheld

    Medical Communications 30 December 2014 Pages: 494 - 497

13. Interconnectivity of Disparate Nonclinical Data Silos for Drug Discovery and Development

    • Jyotsna Kasturi
    • Alan P. Brown
    • Jeremy L. Wally

    Preclinical Studies 30 December 2014 Pages: 498 - 506

14. DIA 2014 50th Annual Meeting Student Poster Abstracts

    Abstracts 30 December 2014 Pages: 507 - 516

15. Statistical Properties of Large Sample Tests for Dose Content Uniformity

    • Øyvind Holte
    • Matej Horvat

    Letter to the Editor 30 December 2014 Pages: NP1 - NP2