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Dietary Supplements: A Framework for Evaluating Safety (2005)
Institute of Medicine (IOM)

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. "Appendix M: Biographical Sketches of Commitee Members." Dietary Supplements: A Framework for Evaluating Safety. Washington, DC: The National Academies Press, 2005.

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Dietary Supplements: A Framework for Evaluating Safety

Daniel L. Azarnoff, M.D., is president of D.L. Azarnoff Associates, through which he does consulting with the pharmaceutical industry. He also serves as senior vice president of Clinical/Regulatory Affairs at Cellegy Pharmaceuticals, Inc. Dr. Azarnoff’s expertise includes pharmaceutical industry administration, pharmacology, clinical pharmacology, and general internal medicine. His research interests include the drug approval process, including preclinical (pharmacology, toxicology, pharmaceutics) and clinical (therapeutic, bioequivalence trials), drugs to treat hyperlipoproteinemia, and transdermal drug delivery. Dr. Azarnoff earned his M.D. from the University of Kansas where he became KUMC Distinguished Professor of Medicine and Pharmacology and previously served as president of Research and Development for the Searle Pharmaceutical Company.

Cindy L. Christiansen, Ph.D., is director, Statistics Section, Center for Health Quality, Outcomes, and Economic Research, which is a Veterans Health Administration Center of Excellence, and is an associate professor of health services at Boston University School of Public Health. Dr. Christiansen, a fellow of the American Statistical Association, has served as chair of their Section on Health Policy Statistics, is an associate editor for the American Statistician, and a column editor for the publication Chance. She is one of the country’s leading experts on hierarchical and predictive models and their use in health services research. Her research interests include the development and implementation of multilevel and prediction models for health service and medical applications, and her methodological work has focused on Poisson models and on models for grouped ordinal data.

Alice M. Clark, Ph.D., serves as vice chancellor for Research and Sponsored Programs at the University of Mississippi and is a Frederick A.P. Barnard Distinguished Professor, as well as a professor of pharmacognosy and research professor of the Research Institute of Pharmaceutical Sciences at the University. Prior to assuming her current position in July 2001, Dr. Clark was director of the National Center for Natural Products Research (NCNPR), which operates as a drug discovery and development program that works on acquisition, preparation, and in vitro evaluation of extracts of higher plants and marine organisms for beneficial activity. Dr. Clark’s research interests are in evaluation of natural compounds for antibiotic and antifungal activity, as well as in the utilization of microorganisms as predictive models for drug metabolism and as synthetic adjuncts. She was part of an NCNPR group working on a Centers for Disease Control and Prevention-funded project to evaluate the potential for botanical dietary supplements to interact with pharmaceuticals, to review the scientific literature on specific botanicals, and to review consumer use of botanical dietary supplements. Dr. Clark also serves as associate editor for the Journal of Natural Products.

Page
482
Front Matter (R1-R20)
Executive Summary (1-18)
1 Introduction and Background (19-42)
2 Approaches Used by Others and Existing Safety Frameworks (43-84)
3 The Framework (85-125)
4 Categories of Scientific Evidence--Human Information and Data (126-155)
5 Categories of Scientific Evidence--Animal Data (156-174)
6 Categories of Scientific Evidence--Information About Related Substances (175-216)
7 Categories of Scientific Evidence--In Vitro Data (217-234)
8 Interactions (235-246)
9 Vulnerable Groups and Prevalance of Use (247-252)
10 Scientific Principles for Integrating and Evaluating the Available Data (253-268)
11 Applying the Framework: Case Studies Using the Prototype Safety Monographs (269-291)
12 Factors Influencing Use of the Safety Framework (292-296)
13 Findings and Recommendations (297-306)
Appendix A: Existing Frameworks or Systems for Evaluating the Safety of Other Substances (307-315)
Appendix B: Scope of Work and Comments to Initial July 2002 Framework (316-321)
Appendix C: Plant Family Information (322-355)
Appendix D: Chaparral: Prototype Monograph Summary (356-362)
Appendix E: Glucosamine: Prototype Monograph Summary (363-366)
Appendix F: Melatonin: Prototype Monograph Summary (367-371)
Appendix G: Chromium Picolinate: Prototype Monograph Summary (372-375)
Appendix H: Saw Palmetto: Prototype Monograph Summary (376-379)
Appendix I: Shark Cartilage: Prototype Monograph Summary (380-384)
Appendix J: Prototype Focused Monograph: Review of Liver-Related Risks for Chaparral (385-449)
Appendix K: Protoype Focused Monograph: Review of Anti-Androgenic Risks of Saw Palmetto Ingestion by Women (450-477)
Appendix L: Acknowledgements (478-480)
Appendix M: Biographical Sketches of Commitee Members (481-488)
Index (489-506)