1. An Index of United States Federal Regulations and Guidelines Which Cover Safety Surveillance of Medical Devices

   • Charles F. Curran
   • Judith M. Sills

   OriginalPaper 30 December 1998 Pages: 313 - 321

2. Adverse Drug Reactions: A Review

   • Munir N. Gharaibeh
   • Howard E. Greenberg
   • Scott A. Waldman

   OriginalPaper 30 December 1998 Pages: 323 - 338

3. Protecting Patients from Harm: Terfenadine and Potential Drug Therapy Interactions

   • Lisa Stockwell Morris
   • Angeline Carlson

   OriginalPaper 30 December 1998 Pages: 339 - 345

4. A Preliminary Assessment of the Impact of Meddra on Adverse Event Reports and Product Labeling

   • Claudia A. White

   OriginalPaper 30 December 1998 Pages: 347 - 362

5. Introduction: Off-Label Uses and High-Cost Drugs: Promotion and Reimbursement Issues

   • Sheila R. Shulman

   OriginalPaper 30 December 1998 Pages: 363 - 365

6. A Shift in the Regulatory Approach

   • Janet Woodcock

   OriginalPaper 30 December 1998 Pages: 367 - 371

7. The Effect of Pharmacy Benefit Manager Clinical Programs and Services on Access to Prescription Drug Benefit Coverage

   • J. Russell Teagarden

   OriginalPaper 30 December 1998 Pages: 373 - 377

8. Implications of Regulatory Policies on Off-Label Uses for Industry Competitiveness

   • Nicholas L. Ruggieri

   OriginalPaper 30 December 1998 Pages: 379 - 381

9. Questions to Ponder Concerning Off-Label Uses

   • John C. Hansen

   OriginalPaper 30 December 1998 Pages: 383 - 384

10. Organization and Responsibilities of the Chemistry, Manufacturing, and Controls Function within Regulatory Affairs: A Survey of 17 Companies

    • Samuel T. Barnett
    • W. Roger
    • Alberto Grignolo

    OriginalPaper 30 December 1998 Pages: 385 - 392

11. A Process for Compliance with Revisions to FDA Regulations

    • David W. Johnson
    • Nikola Coleman
    • Wayne Millar

    OriginalPaper 30 December 1998 Pages: 393 - 399

12. Biostatistical Methodology in Carcinogenicity Studies

    • William R. Fairweather
    • Amit Bhattacharyya
    • Jane Wright

    OriginalPaper 30 December 1998 Pages: 401 - 421

13. A Method of Biased Coin Randomization, Its Implementation, and Its Validation

    • James W. Frane

    OriginalPaper 30 December 1998 Pages: 423 - 432

14. Interpreting Interaction: The Classical Approach

    • Steven M. Snapinn

    OriginalPaper 30 December 1998 Pages: 433 - 438

15. Surrogate Endpoints in Aids Drug Development: Current Status

    • Christy Chuang-Stein
    • Ralph Demasi

    OriginalPaper 30 December 1998 Pages: 439 - 448

16. Commentary on “Surrogate Endpoints In Aids Drug Development: Current Status”, By Christy Chuang-Stein and Ralph Demasi

    • Susan S. Ellenberg

    OriginalPaper 30 December 1998 Pages: 449 - 452

17. Discussion of “Surrogate Endpoints in Aids Drug Development: Current Status” by C. Chuang-Stein and R. Demasi

    • A. Lawrence Gould

    OriginalPaper 30 December 1998 Pages: 453 - 456

18. Rejoinder

    • Christy Chuang-Stein
    • Ralph Demasi

    OriginalPaper 30 December 1998 Pages: 457 - 459

19. Establishing Identification Criteria for Botanicals

    • Peter John Houghton

    OriginalPaper 30 December 1998 Pages: 461 - 469

20. Chemical Identification of Botanical Components Using Liquid Chromatography/Mass Spectrometry

    • Edward H. Kerns
    • Kevin J. Volk
    • Mike S. Lee

    OriginalPaper 30 December 1998 Pages: 471 - 485

21. Chromatographic/Chromatographic Spectroscopic Combination Methods for the Analysis of Botanical Drugs

    • A. Douglas Kinghorn
    • Eun-Kyoung Yuny Seo

    OriginalPaper 30 December 1998 Pages: 487 - 495

22. Use of Fingerprinting and Marker Compounds for Identification and Standardization of Botanical Drugs: Strategies for Applying Pharmaceutical HPLC Analysis to Herbal Products

    • Natalie J. Lazarowych
    • Peter Pekos

    OriginalPaper 30 December 1998 Pages: 497 - 512

23. The Use of Biological Assays to Evaluate Botanicals

    • Jerry L. McLaughlin
    • Lingling L. Rogers
    • Jon E. Anderson

    OriginalPaper 30 December 1998 Pages: 513 - 524

24. Evaluating and Regulating Pharmacoeconomic Information in the Private Sector

    • Peter J. Neumann
    • Darren E. Zinner

    OriginalPaper 30 December 1998 Pages: 525 - 532

25. Creation of a Dictionary of Medical and Lay Terms for use in the Preparation of Patient Information Leaflets

    • Mollie K. Fisch
    • Cathleen A. O’connell

    OriginalPaper 30 December 1998 Pages: 533 - 538

26. Drug Information Activities in Academic Health Centers: A 1996 Survey

    • Karl A. Matuszewski
    • Paul A. Windisch

    OriginalPaper 30 December 1998 Pages: 539 - 546

27. Internet Utilization Among Medical Information Specialists in the Pharmaceutical Industry and Academia

    • Steven T. Johnson
    • Cindy J. Wordell

    OriginalPaper 30 December 1998 Pages: 547 - 554

28. “OTCness”

    • R. William Soller

    OriginalPaper 30 December 1998 Pages: 555 - 560

29. The Ich Guideline for Stability Testing—What Matrixing Does It Permit?

    • David J. Pack

    OriginalPaper 30 December 1998 Pages: 561 - 567

30. Global Data Management: A Winning Approach to Clinical Data Processing

    • Monica Pimazzoni

    OriginalPaper 30 December 1998 Pages: 569 - 571

31. Points to Consider When Implementing a Clinical Quality Assurance Program

    • E. D. Wayne Coen

    OriginalPaper 30 December 1998 Pages: 573 - 575