Abstract
VOLUME 1 * About the Editor * Contributors * Preface * Acknowledgments * Editor's Note * PART I: FUNDAMENTALS OF HERBAL MEDICINE * Chapter 1. History and Regulation of Botanicals in the United States (Loren D. Israelsen and Marilyn Barrett) * Introduction * History * DSHEA Explained * Drugs: OTC and Rx * Prospectus * Chapter 2. Product Definition Deficiencies in Clinical Studies of Herbal Medicines (Varro E. Tyler) * Chapter 3. Identifying and Characterizing Botanical Products (Marilyn Barrett) * Identifying Plants by Name * Means of Assuring Plant Identity * Preparations and Formulations * Dose * Bioavailability * Guidelines * Appendix: Preparations and Formulations * Chapter 4. Standardization of Botanical Preparations: What It Does and Does Not Tell Us (Uwe Koetter and Marilyn Barrett) * Introduction * Standardization of Therapeutic Activity * Standardization to Meet a Chemical Norm * Standardization As a Reflection of Quality Assurance Programs * Guidance * Situation in the Marketplace * Perspective * Chapter 5. The Importance and Difficulty in Determining the Bioavailability of Herbal Preparations (Anton Biber and Friedrich Lang) * Chapter 6. Borrowed and Phytoequivalence: Can Two Herbal Products Be Judged Equivalent? (Marilyn Barrett) * Chemical or Pharmaceutical Equivalency * Bioequivalency or Therapeutic Equivalency * Application of the Concepts, Ginkgo As an Example * Meta-Analyses * Perspective * Chapter 7. Determining Efficacy of Herbal Preparations (Tieraona Low Dog) * Observational Medicine * Evidence-Based Medicine * Summary * Chapter 8. Evaluating Safety of Herbal Preparations (Ezra Bejar, Joseph M. Betz, and Marilyn Barrett) * Evaluation of Safety * Adverse Reactions * Adverse-Event Reporting Systems * Categorization According to the Degree of Safety * Product Quality As an Aspect of Safety * Contraindications * Drug-Herb Interactions * Improving Our Knowledge of Safety * Chapter 9. Conducting Clinical Trials on Herbal Dietary Supplements in North America: Commercialization, Confidence, and Conflicts (Anthony L. Almada) * The Spirit to Sponsor: Is There an Adequate Economic Incentive to Fund Research? * Extracting Value from Science * Competitor Kevlar: Preventing Piracy of Product-Specific Data * How Much Data Is Enough? * We Have Data--Now What? * Who Has Science and How Did They Acquire It? * Conclusion * Chapter 10. Motives for Conducting Clinical Trials on Botanicals in Europe: A Focus on Germany (Joerg Gruenwald and Stefan Spiess) * Chapter 11. Pharmacopoeias and Botanical Monographs (Marilyn Barrett, Roy Upton, and V. Srini Srinivasan) * United States Pharmacopeia and National Formulary (USP-NF) * American Herbal Pharmacopoeia (AHP) and Therapeutic Compendium * European Pharmacopoeia (EP) * British Herbal Pharmacopoeia (BHP) and British Herbal Compendium (BHC) * German Commission E * European Scientific Cooperative of Phytotherapy (ESCOP) * Chinese Pharmacopoeia * African Pharmacopoeia * The Pharmacopoeia of Japan * The Pharmacopoeias of India * World Health Organization (WHO) * Other Pharmacopoeias * Summary and Perspective * Sources of Pharmacopoeias * PART II: METHODS * Chapter 12. Methods of Product and Trial Inclusion and Evaluation (Marilyn Barrett) * Gathering Information on Products and Trials<br
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