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

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. "2 Approaches Used by Others and Existing Safety Frameworks." 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

Upton R, ed. 1997. American Herbal Pharmacopoeia and Therapeutic Compendium. St. John’s Wort, Hypericum perforatum. Quality Control, Analytical and Therapeutic Monograph. Santa Cruz, CA: AHP.

Upton R, ed. 1999. American Herbal Pharmacopoeia and Therapeutic Compendium. Valerian Root, Valerian officinalis. Analytical, Quality Control, and Therapeutic Monograph. Santa Cruz, CA: AHP.

USP. 2002a. The United States Pharmacopeia. The National Formulary. USP 25-NF 20. Rockville, MD: USP.

USP. 2002b. USP Fact Sheet. Online. Available at http://www.usp.org. Accessed June 18, 2002.

USP. 2004. Overview: USP’s Dietary Supplement Verification Program. Online. Available at http://www.uspverified.org/pinfo/overview.html. Accessed March 10, 2004.


WHO (World Health Organization). 1991. Report of the Consultation to Review the Draft Guidelines for the Assessment of Herbal Remedies. Munich, Germany, June 19–21, 1991. Geneva: WHO.

WHO. 1999. WHO Monographs on Selected Medicinal Plants. Vol. I. Geneva: WHO.

WHO. 2001. WHO Monographs of Selected Medicinal Plants. Vol. II. Geneva: WHO.

WHO. 2003. WHO Monographs of Selected Medicinal Plants. Vol. III. Geneva: WHO.

Page
84
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)