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Proposed framework for evaluating the safety of dietary supplements : for comment /
This report outlines a three-step framework for considering the safety of dietary supplement ingredients. The first two steps in the process, "screening/flagging" and "priority setting," are designed to categorize dietary supplement ingredients based on theoretical or possible co...
| Clasificación: | Libro Electrónico |
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| Autor Corporativo: | |
| Formato: | Electrónico eBook |
| Idioma: | Inglés |
| Publicado: |
Washington, D.C. :
National Academy Press,
[2002]
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| Temas: | |
| Acceso en línea: | Texto completo |
MARC
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| 245 | 0 | 0 | |a Proposed framework for evaluating the safety of dietary supplements : |b for comment / |c Committee on the Framework for Evaluating the Safety of Dietary Supplements, Food and Nutrition Board, Board on Life Sciences, Institute of Medicine, National Research Council. |
| 264 | 1 | |a Washington, D.C. : |b National Academy Press, |c [2002] | |
| 300 | |a 1 online resource (1 PDF file (xii, 144 pages)) : |b illustrations | ||
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| 500 | |a Title from PDF title page. | ||
| 504 | |a Includes bibliographical references. | ||
| 520 | 3 | |a This report outlines a three-step framework for considering the safety of dietary supplement ingredients. The first two steps in the process, "screening/flagging" and "priority setting," are designed to categorize dietary supplement ingredients based on theoretical or possible concern, and therefore the immediacy of the need for in-depth evaluation of safety, the third step of the process. | |
| 536 | |a Support for this project was provided by Food and Drug Administration under contract number 223-00-2458. The views presented in this report are those of the Institute of Medicine Committee on the Framework for Evaluating the Safety of Dietary Supplements and are not necessarily those of the funding agencies. | ||
| 588 | 0 | |a Version viewed November 3, 2014. | |
| 505 | 0 | |a FOR COMMENT -- Copyright -- Foreword -- Contents -- Executive Summary -- THE COMMITTEE'S TASK -- BACKGROUND -- FINDINGS -- PROPOSED FRAMEWORK FOR EVALUATING THE SAFETY OF DIETARY SUPPLEMENT INGREDIENTS -- Key Factors Used in the Framework -- Step One: Screening/Flagging -- Step Two: Priority Setting -- Scoring and Sorting the Data -- Sorting the Ingredients by Scores -- Step Three: Critical Safety Evaluation -- Guiding Principles to Follow in Evaluating Data in the Framework -- Attributes of the Proposed Framework | |
| 505 | 8 | |a INGREDIENTS FOR PROTOTYPE MONOGRAPH REVIEWSSECOND PHASE OF THIS STUDY -- 1 Introduction and Background -- COMMITTEE CHARGE -- GENERAL BACKGROUND INFORMATION ABOUT DIETARY SUPPLEMENTS -- Consumer Expectations About Dietary Supplement Safety -- History of the Federal Regulation of Dietary Supplements -- Food and Drugs Act of 1906 -- Federal Food, Drug, and Cosmetic Act of 1938 -- Early Attempts to Regulate the Industry -- Food Additives Amendment of 1958 -- 1976 Proxmire Amendments -- The Nutrition Labeling and Education Act and Health Claims | |
| 505 | 8 | |a The Dietary Supplement and Health Education ActFood and Drug Administration Actions -- Good Manufacturing Practices -- REFERENCES -- 2 Approaches Used by Others to Consider Dietary Supplement Safety and Other Existing Safety Frameworks -- OTHER APPROACHES FOR CONSIDERING DIETARY SUPPLEMENT SAFETY -- Agency for Healthcare Research and Quality -- U.S. Pharmacopeia-National Formulary -- U.S. Pharmacopeia Dietary Supplement Verification Program -- American Herbal Pharmacopoeia -- American Herbal Products Association -- Natural Medicines Comprehensive Database | |
| 505 | 8 | |a World Health OrganizationCommission E -- Health Canada Natural Health Products Directorate -- European Scientific Cooperative on Phytotherapy -- The Physician's Desk Reference for Herbal Medicines and the Physician's Desk Reference for� -- ANALYSIS OF DIFFERENT APPROACHES TO DIETARY SUPPLEMENT EVALUATION -- ATTRIBUTES OF AN IDEAL FRAMEWORK FOR EVALUATING DIETARY SUPPLEMENTS -- REFERENCES -- 3 Outline of the Overall Process for Evaluation of Dietary Supplement Ingredients -- PROPOSED FRAMEWORK FOR EVALUATION OF DIETARY SUPPLEMENT INGREDIENTS | |
| 505 | 8 | |a Ingredients versus ProductsInitiation of the Process -- Description of the Process -- Information or Factors Used to Identify or Flag Ingredients for Further Evaluation -- Evaluation and Weighting of Available Information -- Monograph Preparation, Internal Review, and In-Depth Safety Evaluation -- Ongoing Review and Reassessment -- REFERENCES -- 4 Factors Considered in Screening, Setting Priorities, and Safety Evaluation -- DESCRIPTION AND USE OF KEY FACTORS -- Key Factor: Data from Humans and Clinical Evidence of Harm -- Clinical Trials | |
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| 655 | 6 | |a Livres électroniques. | |
| 710 | 2 | |a Committee on the Framework for Evaluating the Safety of Dietary Supplements, |e issuing body. | |
| 710 | 2 | |a Institute of Medicine (U.S.) | |
| 776 | 0 | 8 | |i Print version: |a Committee on the Framework for Evaluating the Safety of Dietary Supplements. |t Proposed framework for evaluating the safety of dietary supplements. |d Washington, D.C. : National Academy Press, ©2002 |w (OCoLC)156012693 |
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