Coverart for item
The Resource The clinical utility of compounded bioidentical hormone therapy : a review of safety, effectiveness, and use, Donald R. Mattison, Ruth M. Parker, and Leigh Miles Jackson, editors ; Committee on the Clinical Utility of Treating Patients with Compounded Bioidentical Hormone Replacement Therapy, Board on Health Sciences Policy, Health and Medicine Division, National Academies of Sciences, Engineering, Medicine

The clinical utility of compounded bioidentical hormone therapy : a review of safety, effectiveness, and use, Donald R. Mattison, Ruth M. Parker, and Leigh Miles Jackson, editors ; Committee on the Clinical Utility of Treating Patients with Compounded Bioidentical Hormone Replacement Therapy, Board on Health Sciences Policy, Health and Medicine Division, National Academies of Sciences, Engineering, Medicine

Label
The clinical utility of compounded bioidentical hormone therapy : a review of safety, effectiveness, and use
Title
The clinical utility of compounded bioidentical hormone therapy
Title remainder
a review of safety, effectiveness, and use
Statement of responsibility
Donald R. Mattison, Ruth M. Parker, and Leigh Miles Jackson, editors ; Committee on the Clinical Utility of Treating Patients with Compounded Bioidentical Hormone Replacement Therapy, Board on Health Sciences Policy, Health and Medicine Division, National Academies of Sciences, Engineering, Medicine
Contributor
Editor
Issuing body
Subject
Language
eng
Summary
The U.S. Food and Drug Administration (FDA) has approved dozens of hormone therapy products for men and women, including estrogen, progesterone, testosterone, and related compounds. These products have been reviewed for safety and efficacy and are indicated for treatment of symptoms resulting from hormonal changes associated with menopause or other endocrine-based disorders. In recent decades, an increasing number of health care providers and patients have turned to custom-formulated, or compounded, drug preparations as an alternative to FDA-approved drug products for hormone-related health concerns. These compounded hormone preparations are often marketed as "bioidentical" or "natural" and are commonly referred to as compounded bioidentical hormone therapy (cBHT). In light of the fast-growing popularity of cBHT preparations, the clinical utility of these compounded preparations is a substantial public health concern for various stakeholders, including medical practitioners, patients, health advocacy organizations, and federal and state public health agencies. This report examines the clinical utility and uses of cBHT drug preparations and reviews the available evidence that would support marketing claims of the safety and effectiveness of cBHT preparations. It also assesses whether the available evidence suggests that these preparations have clinical utility and safety profiles warranting their clinical use and identifies patient populations that might benefit from cBHT preparations in lieu of FDA-approved BHT
Member of
Cataloging source
NLM
Dewey number
618.175
Funding information
This activity was supported by a contract between the National Academy of Sciences and the U.S. Food and Drug Administration. Any opinions, findings, conclusions, or recommendations expressed in this publication do not necessarily reflect the views of any organization or agency that provided support for the project.
Illustrations
illustrations
Index
no index present
LC call number
RG186
LC item number
.N38 2020eb
Literary form
non fiction
Nature of contents
  • dictionaries
  • bibliography
NLM call number
WK 190
http://library.link/vocab/relatedWorkOrContributorName
  • Mattison, Donald R.
  • Parker, Ruth M.
  • Jackson, Leigh Miles
  • National Academies of Sciences, Engineering, and Medicine (U.S.)
Series statement
Consensus study report of the National Academies of Sciences, Engineering, Medicine
http://library.link/vocab/subjectName
  • Menopause
  • Menopause
  • Menopause
  • Hormone Replacement Therapy
  • Hormones
  • Biosimilar Pharmaceuticals
  • Drug Compounding
  • Treatment Outcome
  • Patient Safety
  • United States
  • Menopause
  • Menopause
Label
The clinical utility of compounded bioidentical hormone therapy : a review of safety, effectiveness, and use, Donald R. Mattison, Ruth M. Parker, and Leigh Miles Jackson, editors ; Committee on the Clinical Utility of Treating Patients with Compounded Bioidentical Hormone Replacement Therapy, Board on Health Sciences Policy, Health and Medicine Division, National Academies of Sciences, Engineering, Medicine
Instantiates
Publication
Bibliography note
Includes bibliographical references
Carrier category
online resource
Carrier category code
  • cr
Carrier MARC source
rdacarrier
Content category
text
Content type code
  • txt
Content type MARC source
rdacontent
Contents
  • Intro -- FrontMatter -- Reviewers -- Preface -- Acknowledgments -- Contents -- Boxes, Figures, and Tables -- Acronyms and Abbreviations -- Summary -- 1 Introduction -- 2 An Overview of Compounding -- 3 Regulatory Framework for Compounded Preparations -- 4 Reproductive Steroid Hormones: Synthesis, Structure, and Biochemistry -- 5 Compounded Bioidentical Hormone Preparations -- 6 Bioavailability of Compounded Bioidentical Hormone Therapy Preparations -- 7 The Safety and Effectiveness of Compounded Bioidentical Hormone Therapy -- 8 The Use of Compounded Bioidentical Hormone Therapy
  • 9 Clinical Utility and Recommendations -- Appendix A: Study Approach -- Appendix B: Study Methods -- Appendix C: Glossary -- Appendix D: Biosketches -- Appendix E: 503A and 503B Distribution Supplement -- Appendix F: Compounded Bioidentical Hormone Therapy Formulations with a Single Active Ingredient -- Appendix G: Compounded Bioidentical Hormone Therapy Formulations with Two or More Active Ingredients -- Appendix H: Boxed Warnings on U.S. Food and Drug Administration-Approved Estrogen and Testosterone Products
Control code
1202479844
Extent
1 online resource (1 PDF file (xxiv, 311 pages))
Form of item
online
Isbn
9780309677158
Lccn
2020941544
Media category
computer
Media MARC source
rdamedia
Media type code
  • c
Other physical details
illustrations.
Specific material designation
remote
System control number
(OCoLC)1202479844
Label
The clinical utility of compounded bioidentical hormone therapy : a review of safety, effectiveness, and use, Donald R. Mattison, Ruth M. Parker, and Leigh Miles Jackson, editors ; Committee on the Clinical Utility of Treating Patients with Compounded Bioidentical Hormone Replacement Therapy, Board on Health Sciences Policy, Health and Medicine Division, National Academies of Sciences, Engineering, Medicine
Publication
Bibliography note
Includes bibliographical references
Carrier category
online resource
Carrier category code
  • cr
Carrier MARC source
rdacarrier
Content category
text
Content type code
  • txt
Content type MARC source
rdacontent
Contents
  • Intro -- FrontMatter -- Reviewers -- Preface -- Acknowledgments -- Contents -- Boxes, Figures, and Tables -- Acronyms and Abbreviations -- Summary -- 1 Introduction -- 2 An Overview of Compounding -- 3 Regulatory Framework for Compounded Preparations -- 4 Reproductive Steroid Hormones: Synthesis, Structure, and Biochemistry -- 5 Compounded Bioidentical Hormone Preparations -- 6 Bioavailability of Compounded Bioidentical Hormone Therapy Preparations -- 7 The Safety and Effectiveness of Compounded Bioidentical Hormone Therapy -- 8 The Use of Compounded Bioidentical Hormone Therapy
  • 9 Clinical Utility and Recommendations -- Appendix A: Study Approach -- Appendix B: Study Methods -- Appendix C: Glossary -- Appendix D: Biosketches -- Appendix E: 503A and 503B Distribution Supplement -- Appendix F: Compounded Bioidentical Hormone Therapy Formulations with a Single Active Ingredient -- Appendix G: Compounded Bioidentical Hormone Therapy Formulations with Two or More Active Ingredients -- Appendix H: Boxed Warnings on U.S. Food and Drug Administration-Approved Estrogen and Testosterone Products
Control code
1202479844
Extent
1 online resource (1 PDF file (xxiv, 311 pages))
Form of item
online
Isbn
9780309677158
Lccn
2020941544
Media category
computer
Media MARC source
rdamedia
Media type code
  • c
Other physical details
illustrations.
Specific material designation
remote
System control number
(OCoLC)1202479844

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