Home

Company Profile


Bert Spilker

Contact Us:

8004 Overhill Road
Bethesda, Maryland
20814-1145

Phone: 301-718-5150
Fax: 301-657-1403
E-mail: bas@bertspilker.com
Alt E-mail: bertspilker0@gmail.com


Brochures: (Acrobat)

  • Bert Spilker & Associates
  • "Enhancing Your Meetings with FDA"
  • . Publications by Bert L. Spilker

    BOOKS:

    Sole Authorship | Joint Authorship | Books Edited | C-D Rom
    Individual Book Chapters (Sole Authorship) | Individual Book Chapters (Multiple Authors)
    Book Reviews | Supplements and Bibliographies | Catalogue (Sole Authorship)
    Selected Commentaries About the Books Authored by Dr. Spilker | Remarks

    A. Sole Authorship

    1. Guide to Clinical Studies and Developing Protocols. Raven Press, New York, 1984. 320 pages. (Six Printings).
    2. 1A. Translated into French - Méthodologie des Études Cliniques. Doin Úditeurs, Paris, 1987. 283 pages.

    3. Guide to Clinical Interpretation of Data. Raven Press, New York, 1986. 372 pages. (Two Printings).
    4. Guide to Planning and Managing Multiple Clinical Studies. Raven Press, New York, 1987. 432 pages. (Two Printings).
    5. Multinational Drug Companies: Issues in Drug Discovery and Development. Raven Press, New York, 1989. 632 pages. (Three Printings). See Number 6.
    6. Guide to Clinical Trials. Raven Press, New York, 1991. 1181 pages.
    7. Multinational Pharmaceutical Companies: Principles and Practices. Raven Press, New York, 1994. 844 pages. This is a second edition of book Number 4.
    8. Medical Dictionary in Six Languages Raven Press, New York, 1995. 665 pages.

    B. Joint Authorship

    1. Presentation of Clinical Data (with Dr. John Schoenfelder). Raven Press, New York, 1990. 568 pages.
    2. Inside the Drug Industry (with Dr. Pedro Cuatrecasas). Prous Science Publishers, Barcelona, 1990. 115 pages. (In second printing).
    3. 2A. Translated into Spanish, 1992
      .
    4. Data Collection Forms in Clinical Trials (with Dr. John Schoenfelder). Raven Press, New York, 1991. 687 pages.
    5. Patient Recruitment in Clinical Trials (with Joyce Cramer). Raven Press, New York, 1992. 365 pages.
    C. Books Edited

    1. Effects of Nuclear Weapons Testing on Health: Report of the Panel of Experts on the Archive of PHS Documents

      • Volume I
        • Chapter III: Processing the Archive, by Bert Spilker and Stephen B. Hulley, pages 17-35.
        • Chapter IV: Dietary and Environmental Measurements of Radioactivity, by Robert J. Hardy and Bert Spilker, pages 37-53.
        • Chapter VI: Birth Defects, by Arno Motulsky and Bert Spilker, pages 77-96.
      • Volume II (Annotated Bibliography) - 124 pages
      • Volume III (Appendices) - 579 pages.
      • Published by the U.S. Superintendent of Documents, Washington, 1980.
    2. Quality of Life Assessments in Clinical Trials. Raven Press, New York, 1990. 476 pages (Two Printings).
      • 2A. Translated into Japanese, 1992.
      • 2B. Second Edition. Raven Press, 1996 (1259 pages).
    3. Patient Compliance in Medical Practice and Clinical Trials. With Joyce Cramer. Raven Press, New York, 1991. 431 pages.
    4. Current Trends and Status in Biomedical Research. Prous Science Publishers, Barcelona, 1993. 123 pages. Issued as the September volume of Drug News and Perspectives, Vol. 6 (7): 449-572.
    5. Quality of Life & Pharmacoeconomics: An Introduction. With Joyce Cramer. Lippincott-Raven, Philadelphia, 1998. 274 pages.

    D. C-D Rom

    1. Guide to Clinical Trials and Patient Recruitment in Clinical Trials Lippincott-Raven, Philadelphia, 1996.
    E. Individual Book Chapters (Sole Authorship)

    1. Development of Orphan Drugs: An Industry Perspective in: Orphan Drugs and Orphan Diseases (Eds.) I.H. Scheinberg and J. Walshe; Manchester University Press, Manchester, UK, 1986 (pages 119-134).
    2. Clinical Evaluation of Topical Antipruritics and Antihistamines in: Models in Dermatology Vol. 3 (Eds.) N.J. Lowe, and H.I. Maibach; S. Karger, Basel, 1986 (pages 55-61).
    3. Practical Considerations in the Clinical Development of CNS Drugs in: Psychopharmacology: The Third Generation of Progress: The Emergence of Molecular Biology and Biological Psychiatry (Ed.) H.Y. Meltzer; Raven Press, New York, 1987 (pages 1659-1666).
    4. Orphan Drugs in Vol. I (General Introduction) of the six volume series Comprehensive Medicinal Chemistry (Ed. of Vol. I): P.D. Kennewell. Overall Ed. is Corwin Hansch; Pergamon Press, Oxford, 1990 (pages 667-674).
    5. Safety Profiles of New Drugs at the Time of Initial Marketing in: Pharmacoepidemiology: An Introduction (Eds.) A.G. Hartzema, M.S. Porta, and H.H. Tilson; Harvey Whitney Books, Cincinnati, Ohio, 1991 (pages 35-46).
    6. Past, Present, and Future Standards of Post-Marketing Surveillance in: Pharmacoepidemiology: An Introduction (Eds.) A.G. Hartzema, M.S. Porta, and H.H. Tilson; Harvey Whitney Books, Cincinnati, Ohio, 1991 (pages 330-343).
    7. An Overview of the Factors that Influence Innovation in: Creating the Right Environment for Drug Discovery (Ed.) S.R. Walker; Quay Publishing, Lancaster, UK, 1991 (pages 11-23).
    8. Improving the Standards of Clinical Trials and Clinical Trial Publications in: Communication in Pharmaceutical Medicine: A Challenge for 1992. (Eds.) J. Ruiz Ferran, J. Lahuerta Dal Re, and R. Lardinois; Prous Science Publishers, Barcelona, 1991 (pages 3-5).
    9. 8A. Translated into Spanish in: Medicina Clinica 98, 1992 (pages 303-304).

    10. How to Conduct More Clinical Trials With Fewer Resources in: Communication in Pharmaceutical Medicine: A Challenge for 1992. (Eds.) J. Ruiz Ferran, J. Lahuerta Dal Re, and R. Lardinois; Prous Science Publishers, Barcelona, 1991 (pages 93-96).
    11. External Influences on Protocol Design in: New Antiepileptic Drug Development: Preclinical and Clinical Aspects (Eds.) J. A. French, M.A. Dichter, and I.E. Leppick; Elsevier, New York, 1993 (pages 115-124).
    12. Health Related Quality of Life in: Quantitative Assessment in Epilepsy Care (Eds.) H. Meinardi, J. Cramer, G. A. Baker, and A. Martins da Silva, Nato ASI Series, Plenum Press, New York, 1993 (pages 177-184).
    13. Career Opportunities for Physicians in the Pharmaceutical Industry in: Careers in Pharmaceutical Medicine (Ed.) P.D. Stonier; John Wiley & Sons, UK, 1994 (pages 107-117).
    14. Project Management Methods in: AMA Management Handbook (3rd Ed.). (Ed.) R. Willis, AMACOM Books, 1994 (pages 7.21-7.24).
    15. Drug Development and Approval Processes in: Avery╣s Drug Treatment (4th Ed.). (Eds.) T.M. Speight and N.H.G. Holford. Adis Press, Auckland, New Zealand, 1997 (pages 423-449).
    16. ICH GCG: Present and Future Activities in: Proceedings of the Fifth International Conference on Harmonisation, San Diego, 2000. (Ed.) M. C. Cone. PJB Pub., Richmond UK, 2001 (pages 306-308)
    F. Individual Book Chapters (Multiple Authors)

    1. Clinical Trial Implementation in: Clinical Evaluation of Psychotropic Drugs: Principles and Guidelines (Eds.) R.F. Prien and D.S. Robinson, Raven Press, New York, 1994. Kartzinel, R., Lisook, A.B., Rullo, B., Severe, J.B., and Spilker, B., 161-184.
    2. Biomarkers and Surrogate Endpoints in Clinical Research: Definitions and Conceptual Model in: Biomarkers and Surrogate Endpoints: Clinical Research and Applications (Ed.) G. J. Downing, Elsevier, Amsterdam, 2000. With 12 Co-authors, 1-9.
    3. Establishing the Research Infrastructure to Develop and Classify Clinical Biomarkers in: Biomarkers and Surrogate Endpoints: Clinical Research and Applications (Ed.) G.J. Downing, Elsevier, Amsterdam, 2000. Cohen, A., Oates, J. A., Spilker, B., and Zeger, S.L., 307-314.

    G. Book Reviews

    1. Modern Methods of Clinical Investigation. In International Journal of Technology Assessment in Health Care, 7, 422, 1991.
    2. Drug Regulation in Japan. In JAMA, 268, 659-660, 1992.
    3. Meta-Analysis. In JAMA, 269, 3041, 1993.
    4. Pharmaceutical Industry. In JAMA, 275, 73-74, 1996.
    5. Clinical Trials Dictionary. In Applied Clinical Trials, September 1999, 93-94.
    H. Supplements and Bibliographies

    1. Quality of Life Bibliography and Indexes by B. Spilker, F.R. Molinek, Jr., K.A. Johnston, R.L. Simpson, Jr., and H.H. Tilson. Medical Care Supplement Vol. 28, December, 1990 (77 pages).
    2. Quality of Life Bibliography and Indexes: 1990 Update by B. Spilker, W.S.A. White, R.L. Simpson, Jr., and H.H. Tilson. J. Clin. Res. and Pharmacoepidemiology 6, 87-156, 1992.
    3. Quality of Life Bibliography and Indexes: 1991 Update by B. Spilker, R.L Simpson, Jr., and H.H. Tilson. J. Clin. Res. Pharmacoepidemiology 6, 205-266, 1992.
    I. Catalogue (Sole Authorship)

    1. Keys and Locks: The Collection of the Cooper-Hewitt Museum, The Smithsonian Institution's National Museum of Design. Pub. 1987. Guest curator for the Smithsonian's exhibition: Safe and Secure: Keys and Locks. Held at the Cooper-Hewitt Museum, in New York from June 9 to October 18, 1987.
    J. Selected Commentaries About the Books Authored by Dr. Spilker<P>
    1. An Interview With Bert Spilker. Drug News and Perspectives, Vol. 1, 60-61, 1988.
    2. A Closer Look at Clinicals. Harry Schwartz. Pharmaceutical Executive, 14, 16, January 1987.
    3. Inside the Drug Industry. Drug News and Perspectives, Vol. 3, 511-512, 1990.
    K. Remarks

    1. Welcome Remarks. (Opening Plenary Session of the International Conference on Harmonisation). In: Proceedings of the Fifth International Conference on Harmonisation, San Diego, 2000. Ed. By M. C. Cone. Pub by PJB Publications, Richmond, UK, 2001 (page 1)

    Copyright © 2002-2013 Bert Spilker & Associates, LLC. All rights reserved.