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The Clinical Utility of Compounded Bioidentical Hormone Therapy A Review of Safety, Effectiveness, and Use (2020) / Chapter Skim
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Appendix A: Study Approach
Pages 229-238

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From page 229...
... COMMITTEE EXPERTISE The National Academies appointed a 12-member committee of experts to address objectives in the Statement of Task. The resulting committee included experts in a variety of disciplines and fields, including drug research and development, pharmacology, toxicology, endocrinology, epidemiology, health literacy, pharmaceutical compounding and manufacturing, health risk mitigation, and health policy.
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From page 230...
... The agendas for the five open-session meetings are presented here. First Committee Meeting Open Session Agenda Tuesday, March 5, 2019 National Academies Keck Center 500 Fifth Street, NW, Washington, DC 20001 Part I Sponsor Briefing: Discussion of the Committee's Charge 1:15 p.m.
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From page 231...
... ADJOURN Second Committee Meeting Open Session Workshop Agenda Monday, May 6, 2019 National Academies Keck Center 500 Fifth Street, NW, Washington, DC 20001 9:00 a.m. Introductions Leigh Miles Jackson, Ph.D., Study Director Board on Health Sciences Policy Health and Medicine Division Donald Mattison, M.D.
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From page 232...
... LUNCH BREAK Session III Pharmaceutical Sciences and Compounding Panel 1:45 p.m. Perspectives from Compounding Pharmacists A
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From page 233...
... ADJOURN Third Committee Meeting Open Session Agenda Thursday, June 27, 2019 National Academies Keck Center 500 Fifth Street, NW, Washington, DC 20001 12:45 p.m. Welcome and Introductions Donald Mattison, M.D.
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From page 234...
... Introductions Leigh Miles Jackson, Ph.D., Study Director Board on Health Sciences Policy Health and Medicine Division Donald Mattison, M.D. Committee Chair Ruth Parker, M.D.
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From page 235...
... ADJOURN Seventh Committee Meeting Open Session Agenda Tuesday, January 14, 2019 National Academies Keck Center 500 Fifth Street, NW, Washington, DC 20001 12:00 p.m. Introductions Leigh Miles Jackson, Ph.D., Study Director Board on Health Sciences Policy Health and Medicine Division Donald Mattison, M.D.
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From page 236...
... For example, relevant data were sub­ itted m by stakeholders, including FDA, Professional Compounding Centers of America, National Association of Boards of Pharmacy, Massachusetts Board of Registration in Pharmacy, Office of Tennessee Attorney General, National Women's Health Network, representatives of 503A compounding pharmacies and 503B outsourcing facilities; an editor-in-chief of a leading compounding journal; nonprofit medical and pharmaceutical societies and organizations; compounding advocacy organizations; and nonprofit wellness organizations; women's health advocacy groups; and medical ­ rescribers and researchers of cBHT. Several testimonies, position statep ments, and letters were also submitted by Alliance for Natural Health, Alliance for Pharmacy Compounding, American Pharmacists Association,
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From page 237...
... Similarly, respondents reported relying on their physicians, as well as Internet sources, books, 1  Stakeholders included medical societies, wellness centers and organizations, women's health organizations, pharmacy associations, compounding organizations, government agencies, and education and research institutions.
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From page 238...
... Respondents Who Identified as Pharmacists or Compounders The respondents to the pharmacist and compounder questionnaire ­ escribed a reliance on both published literature and professional experid ence for evidence on the potential safety and effectiveness of cBHT preparations. Resources for patients who describe the safety of cBHT formations varied -- some respondents only provided oral instructions for use, others shared resources from compounding trade organizations, and still others distributed written information and instructions that were developed in house.
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Key Terms

  • cbht preparations
  • hormone therapy
  • pharmaceutical sciences
  • pharmacists association
  • respondents expressed

  • professional compounding
  • compounded bioidentical
  • potential safety
  • quantitative data
  • compounding pharmacists

  • respondents reported
  • pharmaceutical compounding
  • american pharmacists
  • compounding centers
  • reed smith

  • national community
  • bioidentical hormone
  • smith llp
  • pharmacy associations
  • testimonial evidence

  • resources submitted
  • virtual meetings
  • consumer questionnaire
  • current evidence
  • stakeholders included

  • resulting committee
  • written information
  • medical societies
  • international journal
  • oral instructions


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