1. Prescription Drug Advertising and Promotion: Learnings from Recent Food and Drug Administration Warning Letters

   • Eric B. Benson
   • Sherman N. Alfors

   Drug Development 30 December 2007 Pages: 281 - 289

2. A Comparison of the Drug Review Process at Five International Regulatory Agencies

   • Mayu Hirako
   • Neil McAuslane
   • Stuart Walker

   Drug Development 30 December 2007 Pages: 291 - 308

3. Exploratory IND Studies: A Review of Food and Drug Administration Guidance and Similar Provision in Europe

   • Faraneh Attarchi

   Drug Development 30 December 2007 Pages: 309 - 314

4. Potential Predictors of Placebo Response: Lessons from a Large Database

   • Richard Entsuah
   • Phil Vinall

   Statistics 30 December 2007 Pages: 315 - 330

5. Revolutionizing the Role of Quality Assurance in Clinical Trials

   • Patricia W. Brown
   • Melissa P. Ball

   Quality Assurance 30 December 2007 Pages: 332 - 342

6. Introduction

   • Roger W. Croswell

   Regulatory Affairs 30 December 2007 Pages: 343 - 343

7. The Probability of Registrational Success

   • Charles A. Maniglia

   Regulatory Affairs 30 December 2007 Pages: 345 - 347

8. The 505(b)(2) New Drug Application

   • J. Christopher Prue
   • Arthur J. Mayorga

   Regulatory Affairs 30 December 2007 Pages: 349 - 352

9. Perspective on Quality Risk Management of Pharmaceutical Quality

   • H. Gregg Claycamp

   Regulatory Affairs 30 December 2007 Pages: 353 - 367

10. Special Section on Clinical Research Standards Introduction

    • Paul Bleicher
    • Wayne Kubick
    • Rebecca Kush

    Clinical Research Standard 30 December 2007 Pages: 369 - 371

11. Toward a Comprehensive CDISC Submission Data Standard

    • Wayne R. Kubick
    • Stephen Ruberg
    • Edward Helton

    Clinical Research Standard 30 December 2007 Pages: 373 - 382

12. A Standard Computable Clinical Trial Protocol: The Role of the BRIDG Model

    • Cara Willoughby
    • Doug Fridsma
    • Rebecca Kush

    Clinical Research Standard 30 December 2007 Pages: 383 - 392

13. Data Standards: At the Intersection of Sites, Clinical Research Networks, and Standards Development Initiatives

    • Brian McCourt
    • Robert A. Harrington
    • Meredith Nahm

    Clinical Research Standard 30 December 2007 Pages: 393 - 404

14. Controlled Terminology for Clinical Research: A Collaboration between CDISC and NCI Enterprise Vocabulary Services

    • Margaret W. Haber
    • Bron W. Kisler
    • Lawrence W. Wright

    Clinical Research Standard 30 December 2007 Pages: 405 - 412

15. 7th Middle East Regulatory Conference (MERC)

    • Elaine Whiting
    • Afschin Khodaverdi-Afaghi
    • Marie-Claire Beurier

    Proceedings 30 December 2007 Pages: 413 - 421

16. 2007 Annual Meeting Student Poster Abstracts

    Abstracts 30 December 2007 Pages: 423 - 428

17. Manual of Drug Safety and Pharmacovigilance

    • Paul Stang

    Book Review 30 December 2007 Pages: 429 - 430