1. The International Council for Harmonisation and a Case Study in Regulatory Science

   • J. Rick Turner

   Editorial 19 December 2019 Pages: 561 - 563

2. Innovation and Opportunities in Pediatric Therapeutic Development

   • Susan McCune
   • Ronald J. Portman

   Special Section: Pediatric Therapeutic Development: Editorial 19 December 2019 Pages: 564 - 566

3. Incorporating Innovative Techniques Toward Extrapolation and Efficient Pediatric Drug Development

   • Margaret Gamalo-Siebers
   • Lisa Hampson
   • Ronald Portman

   Special Section: Pediatric Therapeutic Development: Original Article 19 December 2019 Pages: 567 - 578

4. Pharmacometrics in Pediatrics

   • Xiaoxi Liu
   • Robert M. Ward

   Special Section: Pediatric Therapeutic Development: Commentary 19 December 2019 Pages: 579 - 583

5. Pediatric Age Groups and Approach to Studies

   • Kathleen M. Job
   • Margaret Gamalo
   • Robert M. Ward

   Special Section: Pediatric Therapeutic Development: Commentary 19 December 2019 Pages: 584 - 589

6. What Could the Future of Safety Monitoring Look Like?

   • Steven Hirschfeld
   • Anne Zajicek

   Special Section: Pediatric Therapeutic Development: Commentary 19 December 2019 Pages: 590 - 600

7. Role of Patients and Parents in Pediatric Drug Development

   • Vivian W. L. Tsang
   • Leanne West
   • Charles Thompson

   Special Section: Pediatric Therapeutic Development: Special Section 19 December 2019 Pages: 601 - 608

8. Impact of Regulatory Incentive Programs on the Future of Pediatric Drug Development

   • Elizabeth Yen
   • Jonathan M. Davis
   • Christopher-Paul Milne

   Special Section: Pediatric Therapeutic Development: Review Article 19 December 2019 Pages: 609 - 614

9. Tiny and Forgotten: A Call for Focused Neonatal Policy Reform

   • Christina M. Bucci-Rechtweg
   • Robert M. Ward

   Special Section: Pediatric Therapeutic Development: Commentary 19 December 2019 Pages: 615 - 617

10. Public Understanding and Awareness of Isotretinoin Use and Safety in Al Ahsa, Eastern Saudi Arabia

    • Nancy S. Younis
    • Nourah Yousef Al-Harbi

    Biostatistics: Original Article 19 December 2019 Pages: 618 - 622

11. Statistical Considerations for Bias and Protocol Deviation in Medical Device Pivotal Clinical Study

    • Zhiheng Xu
    • Meijuan Li

    Biostatistics: Original Article 19 December 2019 Pages: 623 - 629

12. The Potential Role of Individual-Level Benefit-Risk Assessment in Treatment Decision Making: A DIA Study Endpoints Community Workstream

    • Matthew Reaney
    • Elizabeth Bush
    • Adam Gater

    Special Section: Pediatric Therapeutic Development: Commentary 19 December 2019 Pages: 630 - 638

13. How Did These Data Get Here? Recommendations for the Analysis of Data From ClinicalTrials.gov

    • Todd A. Durham

    Clinical Trial: Commentary 19 December 2019 Pages: 639 - 640

14. Cancer Clinical Trials: Treatment Costs Associated With a Spanish National Health System Institution

    • Ferran Capdevila
    • Ruth Vera
    • Eduardo Sanchez-Iriso

    Clinical Trial: Original Article 19 December 2019 Pages: 641 - 647

15. Entry Into New Therapeutic Areas: The Effect of Alliance on Clinical Trials

    • Kinya Okada
    • Shintaro Sengoku

    Clinical Trial: Original Article Open access 19 December 2019 Pages: 648 - 653

16. Postgraduate Education in Pharmaceutical Medicine in Australia: Evaluation and Evolution to a Global Program Over 20 Years

    • Gabrielle M. Allen
    • Orin Chisholm

    Educational Perspective: Original Article 19 December 2019 Pages: 654 - 660

17. Regulatory Requirements and Innovation: A Comparison of the Dermatologic Antifungal Drug Product Markets in Brazil and United States

    • Bianca Kollross
    • Marcilio Cunha-Filho
    • Tais Gratieri

    Global Perspective: Original Article 19 December 2019 Pages: 661 - 668

18. Survey of Awareness and Perceptions of Canadians on the Benefits and Risks of Clinical Trials

    • Donald J. Willison
    • Dawn P. Richards
    • Susan Marlin

    Global Perspective: Original Article Open access 19 December 2019 Pages: 669 - 677

19. Changes in the Number and Employment Conditions of Clinical Research Coordinators in South Korea

    • Ihn Sook Jeong
    • Youn Sun Hwang
    • Ji Hyang Youn

    Global Perspective: Original Article 19 December 2019 Pages: 678 - 683

20. Comparisons of Usual Dose of Pharmaceutical Products Used in Japan and United States: Can Differences Be Explained by Pharmacokinetics Alone?

    • Risa Takayanagi
    • Yuuki Endo
    • Yasuhiko Yamada

    Global Perspective: Original Article 19 December 2019 Pages: 684 - 690

21. Clinical Research Coordinators’ Attitude Toward Risk-Based Monitoring

    • Ihn Sook Jeong
    • Jeong Hee Jeong
    • Ji Hyang Youn

    Regulatory Science: Original Article 19 December 2019 Pages: 691 - 695

22. Abbreviated New Drug Applications: Generic Drug User Fee Amendments Act Analysis of Application Quality Metrics

    • Jason Woo
    • Jingyu (Julia) Luan
    • Howard Chazin

    Regulatory Science: Original Article 19 December 2019 Pages: 696 - 700

23. 21st-Century Oncology Drug Safety via New-Age Regulatory Standards and Practices

    • Peter J. Pitts
    • Hervé Le Louet
    • Gregory Katz

    Regulatory Science: Commentary 19 December 2019 Pages: 701 - 705

24. Costs of Quality in Clinical Development

    • Bolennart Eriksson

    Regulatory Science: Original Article 19 December 2019 Pages: 706 - 713