1. Quite a Third Birthday

   • Stephen P. Spielberg

   Editorial 30 December 2016 Pages: 143 - 143

2. Statistical Monitoring in Clinical Trials: Best Practices for Detecting Data Anomalies Suggestive of Fabrication or Misconduct

   • David Knepper
   • Anne S. Lindblad
   • Yodit Seifu

   Sponsored Special Section by TransCelerate BioPharma: Original Research Open access 30 December 2016 Pages: 144 - 154

3. Birth Control in Clinical Trials: Industry Survey of Current Use Practices, Governance, and Monitoring

   • J. Stewart
   • W. J. Breslin
   • C. L. Chen

   Clinical Trials: Original Research Open access 30 December 2016 Pages: 155 - 168

4. Who Said It Better? A Test of Wording Differences in the MedWatch “Toll-Free Statement” for Consumer Reporting of Side Effects in Direct-to-Consumer Television Advertisements

   • Kathryn J. Aikin
   • Amie C. O’Donoghue
   • Claudia Squire

   Product Safety: Original Research 30 December 2016 Pages: 169 - 173

5. Community Opinions on the Collection and Use of Historical Control Data in Nonclinical Toxicity Studies

   • Lauren Murphree Mihalcik
   • Megan Bausman
   • Joyce Zandee

   Product Safety: Original Research 30 December 2016 Pages: 174 - 187

6. Statistical Analysis of Cumulative Serious Adverse Event Data From Development Safety Update Reports

   • Brian Davis
   • Harry Southworth

   Product Safety: Original Research 30 December 2016 Pages: 188 - 194

7. CBER’s Experience With Adaptive Design Clinical Trials

   • Min Lin
   • Shiowjen Lee
   • Estelle Russek-Cohen

   Product Development and Innovation: Original Research 30 December 2016 Pages: 195 - 203

8. The Score Card Approach: A First Step Toward an Evidence-based Differentiation Assessment for Tablets

   • Klaus Pekari
   • Thomas Fürst
   • Patricia Watson

   Product Development and Innovation: Original Research 30 December 2016 Pages: 204 - 212

9. Profit Evaluations When Adaptation by Design Is Applied

   • Daniele De Martini

   Drug Development: Original Research 30 December 2016 Pages: 213 - 220

10. Comparative Analysis Between the Top-Selling Drugs in the Japanese Pharmaceutical Market and Those in the United States, the United Kingdom, France, and Germany

    • Shoyo Shibata
    • Ryotaro Uemura
    • Takeshi Suzuki

    Global Perspectives: Original Research 30 December 2016 Pages: 221 - 227

11. Evaluation of Safety Profiles of Blood Cancer Drugs Approved in Japan

    • Sachie Kubota
    • Kazuyuki Saito
    • Yasuo Kodama

    Global Perspectives: Original Research 30 December 2016 Pages: 228 - 235

12. Pharmaceutical Pricing Policies and Procedures in Saudi Arabia: A Narrative Review

    • Tahir Mehmood Khan
    • Promise Emeka
    • Hisham Aljadhey

    Global Perspectives: Review 30 December 2016 Pages: 236 - 240

13. Validation of Prognostic Marker Tests: Statistical Lessons Learned From Regulatory Experience

    • Rong Tang
    • Gene Pennello

    Statistics: Review 30 December 2016 Pages: 241 - 252