1. The European Agency for the Evaluation of Medicinal Products’ Centralized Procedure for Product Approval: Current Status

   • Elaine M. Healy
   • Kenneth I. Kaitin

   OriginalPaper 30 December 1999 Pages: 969 - 978

2. The Role of the Company Witness

   • Michael DeMarco

   OriginalPaper 30 December 1999 Pages: 979 - 985

3. Preparing Articles for Publication: A Guide for the Writer Who Must Meet Multiple Objectives

   • Stephanie Phillips

   OriginalPaper 30 December 1999 Pages: 987 - 992

4. Herbal Products: Advances in Preclinical and Clinical Development

   • Michael Habs

   OriginalPaper 30 December 1999 Pages: 993 - 1001

5. Rationale for Drug Development of Herbals in Oncology: Clinical, Industry, and Regulatory Perspectives

   • Mary Ann Richardson
   • Carmen Tamayo
   • Norman Marcon

   OriginalPaper 30 December 1999 Pages: 1003 - 1010

6. Conducting a Clinical Research Department Process Audit: Methodology and Findings

   • Douglas R. Mackintosh
   • Vernette J. Molloy

   OriginalPaper 30 December 1999 Pages: 1011 - 1024

7. A Household Survey of Source, Availability, and use of Antimalarials in a Rural Area of Tanzania

   • Stephen E. D. Nsimba
   • Marian Warsame
   • Zebwe A. Mbatiya

   OriginalPaper 30 December 1999 Pages: 1025 - 1032

8. Incorporating Affiliates and Contract Research Organizations into Global Clinical Trials

   • S. Michael Harrill
   • Jane M. Boswick
   • Susan M. Meloy

   OriginalPaper 30 December 1999 Pages: 1033 - 1052

9. Economic Analysis in Clinical Trials: Practical Considerations

   • Andrew M. Baker
   • Renée J. Goldberg Arnold
   • Diana J. Kaniecki

   OriginalPaper 30 December 1999 Pages: 1053 - 1060

10. Clinical Trial Management and Remote Data Entry on the Internet

    • Roberto Scognamillo
    • Carlo Strozzi
    • Giuseppe Recchia

    OriginalPaper 30 December 1999 Pages: 1061 - 1065

11. Promoting Optimal Antibiotic Therapy for Otitis Media Using Commercially Sponsored Evidence-Based Detailing: A Prospective Controlled Trial

    • Lisa Dolovich
    • Mitchell Levine
    • Eric Duku

    OriginalPaper 30 December 1999 Pages: 1067 - 1077

12. Advances in Volume Encoding Clinical Data

    • Keya Pitts
    • Kathleen Jelliffe
    • Lionel Benson

    OriginalPaper 30 December 1999 Pages: 1079 - 1092

13. Pharmaceutical Research and Manufacturers of America/Food and Drug Administration Cooperation in Building Capabilities for Electronic Submission of Postmarketing Safety Data

    • William S. Calvert
    • Virginia Holihan

    OriginalPaper 30 December 1999 Pages: 1093 - 1099

14. Electronic Reporting of Adverse Event Data to the Food and Drug Administration: The Experiences of Glaxo Wellcome And Zeneca As Participants in the Adverse Event Reporting System Pilot Project

    • Mark Blake
    • Vlasta Pinkston

    OriginalPaper 30 December 1999 Pages: 1101 - 1108

15. A Successful Global Drug Safety System: The Hoffmann-La Roche Experience

    • Alan L. Bess

    OriginalPaper 30 December 1999 Pages: 1109 - 1116

16. Evaluation of Spontaneous Adverse Event Reports by Primary Reporter—A 15-Year Review (1983 to 1997)

    • Kenneth Hornbuckle
    • Hsiao-Hui Wu
    • Man C. Fung

    OriginalPaper 30 December 1999 Pages: 1117 - 1124

17. Pharmaceuticals and Pregnancy: From Testing to Labeling

    • Jan Willem van Der Laan
    • Klaus Olejniczak

    OriginalPaper 30 December 1999 Pages: 1125 - 1133

18. Drugs in Pregnancy — The Dilemma of Labeling

    • Bengt Källén

    OriginalPaper 30 December 1999 Pages: 1135 - 1143

19. Nonparametric Analysis of Covariance and Its Role in Noninferiority Clinical Trials

    • Gary G. Koch
    • Catherine M. Tangen

    OriginalPaper 30 December 1999 Pages: 1145 - 1159

20. Use of Meta-Analysis to Evaluate Medical Questions of Interest: An Application to Studies of Secondary Prevention of Acute Myocardial Infarction

    • Ya-Ting Chen
    • Robert W. Makuch

    OriginalPaper 30 December 1999 Pages: 1161 - 1171

21. A Health-Related Quality of Life Measure in Patients with Deep Vein Thrombosis: A Validation Study

    • Susan D. Mathias
    • Lee Ann Prebil
    • Anthony J. Comerota

    OriginalPaper 30 December 1999 Pages: 1173 - 1187

22. Clinical Equivalence—A Clarification

    • Christy Chuang-Stein

    OriginalPaper 30 December 1999 Pages: 1189 - 1194

23. Calculation of the Probability of Multiplicities in Two Cell-Occupancy Models: Implications for Spontaneous Reporting Systems

    • John A. Clark
    • Robert H. Berk
    • Stephen L. Klincewicz

    OriginalPaper 30 December 1999 Pages: 1195 - 1203

24. Design Issues in Noninferiority/Equivalence Trials

    • Irving K. Hwang
    • Toshihiko Morikawa

    OriginalPaper 30 December 1999 Pages: 1205 - 1218

25. Issues in Adjusting for Covariates Arising Postrandomization in Clinical Trials

    • James Rochon

    OriginalPaper 30 December 1999 Pages: 1219 - 1228