Description
VOLUME 1 About the Editor Contributors Preface Acknowledgments Editors 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 Science 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 Bjar, 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 DataNow 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
