Coverart for item
The Resource Bone toxicology, Susan Y. Smith, Aurore Varela, Rana Samadfam, editors, (electronic resource)

Bone toxicology, Susan Y. Smith, Aurore Varela, Rana Samadfam, editors, (electronic resource)

Label
Bone toxicology
Title
Bone toxicology
Statement of responsibility
Susan Y. Smith, Aurore Varela, Rana Samadfam, editors
Contributor
Editor
Subject
Language
eng
Summary
The content of this book is intended to provide the toxicologist in drug development in the pharmaceutical and biotechnology industries with a broad understanding of bone and its interactions with other organ systems in safety assessments. The book is divided into three parts. The first part describes our current understanding of bone biology and its primary regulatory pathways. Additional chapters address regulatory and study design considerations for incorporating bone end points in toxicology studies, with special consideration being given to juvenile toxicology studies. This is intended to address recent regulatory requirements to evaluate skeletal development for drugs in development for pediatric populations. The second part of the book describes the principal techniques and methods used in bone research; understanding how these end-points are derived is fundamental to their appropriate application. These first two parts of the book provide the background and the means to develop the concepts in part three which describes bone and its interaction with other organ systems. The unique series of chapters in part three, contributed to by key leaders in their respective fields and in bone research, provides a comprehensive collective work. Although constantly evolving, the crosstalk and interaction of the skeleton with several organ systems is now recognized and well documented, such as for the reproductive system, muscle and kidney, while our understanding of the interaction with other organ systems, such as the immune system and CNS, is in its infancy. Recent work highlights the key role of the skeleton in the regulation of energy metabolism and the impact this has on research in metabolic diseases such as obesity and diabetes. The hope is that this book will enlighten many and encourage more to explore the impact of new compounds on the skeleton in the development of effective and safe drugs
Member of
Cataloging source
YDX
Dewey number
615.9
Index
index present
LC call number
RA1211
Literary form
non fiction
Nature of contents
dictionaries
http://library.link/vocab/relatedWorkOrContributorName
  • Smith, Susan Y.
  • Varela, Aurore
  • Samadfam, Rana
Series statement
Molecular and integrative toxicology
http://library.link/vocab/subjectName
  • Toxicology
  • Bones
Label
Bone toxicology, Susan Y. Smith, Aurore Varela, Rana Samadfam, editors, (electronic resource)
Instantiates
Publication
Note
Includes index
Contents
  • Foreword; Preface; Contents; About the Editors; Part I: Bone Toxicology in Preclinical Drug Testing; Chapter 1: Introduction and Considerations in Bone Toxicology; 1.1 Introduction; 1.2 Regulatory Considerations; 1.3 Tier Approach to Including Specialized Bone End-Points in Preclinical Toxicology Studies; 1.4 Considerations for Study Design; 1.4.1 Biochemical Markers of Bone Turnover; 1.4.2 Environmental Conditions and Diet; 1.4.3 Radiography and Bone Densitometry; 1.4.4 Bone Histomorphometry; 1.4.5 Biomechanical Strength Testing; 1.4.6 Considerations for Selection of Test System
  • 1.4.7 Summary of Considerations for Study Design: Take Home Messages1.5 Animal Models; 1.6 Data Interpretation: Skeletal Adversity; 1.7 Conclusions; References; Chapter 2: Bone Physiology and Biology; 2.1 Bone Biology; 2.1.1 Bone Composition; 2.1.2 The Mineral; 2.1.3 The Organic Phase; 2.1.4 Osteoblasts; 2.1.5 Osteocytes; 2.1.6 Osteoclasts; 2.2 Skeletal Growth, Adaptation, and Maintenance; 2.2.1 Skeletal Growth and Bone Modeling; 2.2.2 Bone Remodeling; 2.3 Comparative Bone Biology; 2.3.1 Nonhuman Primates; 2.3.1.1 Strengths of the Nonhuman Primate Model
  • 2.3.1.2 Limitations of the Nonhuman Primate Model2.3.1.3 Methods and Study End-Points Available for Nonhuman Primates; 2.3.2 Rats; 2.3.2.1 Strengths and Limitations of the Rat Model; 2.3.2.2 Methods and Study End-Points Available for Rats; 2.3.3 Mice; 2.3.3.1 Strengths and Limitations of Mouse Models; 2.3.3.2 Methods and Study End-Points Available for Mice; References; Chapter 3: Specific Considerations for Bone Evaluations for Pediatric Therapeutics; 3.1 Introduction; 3.2 Postnatal Skeletal Development; 3.3 Growth; 3.3.1 Concepts; 3.3.2 Importance; 3.3.3 Preclinical Measurements
  • 3.3.3.1 Rodents: In Vivo3.3.3.2 Rodents: Ex Vivo; 3.3.3.3 Non-rodents: In Vivo; 3.3.3.4 Non-rodents: Ex Vivo; 3.3.3.5 Data Interpretation; 3.4 Postnatal Therapies; 3.4.1 Anticancer Agents; 3.4.2 Retinoids; 3.4.3 Corticosteroids; 3.4.4 Anti-infectives; 3.4.5 CNS Therapies: Selective Serotonin Reuptake Inhibitors (SSRIs); 3.4.6 CNS Therapies: Antipsychotics; 3.4.7 Bisphosphonates; 3.4.8 Therapies to Affect Growth; 3.4.9 Bone Morphogenetic Protein; 3.4.10 Review of Agents
  • 3.5 Designs of Juvenile Toxicology Testing Programs for Pharmaceuticals and Biopharmaceuticals Where the Skeleton Is an Organ System of Concern3.5.1 Overview; 3.5.2 Program Design; 3.5.3 Species and Strain Selection; 3.5.4 Study Design; 3.6 Conclusions; References; Chapter 4: Animal Models in Bone Research; 4.1 Regulatory Guidelines for Animal Models of Osteoporosis; 4.2 A Perspective on In Vivo Experimentation; 4.3 Criteria for Animal Models in Osteoporosis; 4.3.1 Summary; 4.3.2 Postmenopausal Osteoporosis; 4.3.2.1 Growth and Adult Phases; 4.3.2.2 Role of Estrogen
Dimensions
unknown
Extent
1 online resource.
Form of item
online
Isbn
9783319561905
Specific material designation
remote
System control number
on1005188699
Label
Bone toxicology, Susan Y. Smith, Aurore Varela, Rana Samadfam, editors, (electronic resource)
Publication
Note
Includes index
Contents
  • Foreword; Preface; Contents; About the Editors; Part I: Bone Toxicology in Preclinical Drug Testing; Chapter 1: Introduction and Considerations in Bone Toxicology; 1.1 Introduction; 1.2 Regulatory Considerations; 1.3 Tier Approach to Including Specialized Bone End-Points in Preclinical Toxicology Studies; 1.4 Considerations for Study Design; 1.4.1 Biochemical Markers of Bone Turnover; 1.4.2 Environmental Conditions and Diet; 1.4.3 Radiography and Bone Densitometry; 1.4.4 Bone Histomorphometry; 1.4.5 Biomechanical Strength Testing; 1.4.6 Considerations for Selection of Test System
  • 1.4.7 Summary of Considerations for Study Design: Take Home Messages1.5 Animal Models; 1.6 Data Interpretation: Skeletal Adversity; 1.7 Conclusions; References; Chapter 2: Bone Physiology and Biology; 2.1 Bone Biology; 2.1.1 Bone Composition; 2.1.2 The Mineral; 2.1.3 The Organic Phase; 2.1.4 Osteoblasts; 2.1.5 Osteocytes; 2.1.6 Osteoclasts; 2.2 Skeletal Growth, Adaptation, and Maintenance; 2.2.1 Skeletal Growth and Bone Modeling; 2.2.2 Bone Remodeling; 2.3 Comparative Bone Biology; 2.3.1 Nonhuman Primates; 2.3.1.1 Strengths of the Nonhuman Primate Model
  • 2.3.1.2 Limitations of the Nonhuman Primate Model2.3.1.3 Methods and Study End-Points Available for Nonhuman Primates; 2.3.2 Rats; 2.3.2.1 Strengths and Limitations of the Rat Model; 2.3.2.2 Methods and Study End-Points Available for Rats; 2.3.3 Mice; 2.3.3.1 Strengths and Limitations of Mouse Models; 2.3.3.2 Methods and Study End-Points Available for Mice; References; Chapter 3: Specific Considerations for Bone Evaluations for Pediatric Therapeutics; 3.1 Introduction; 3.2 Postnatal Skeletal Development; 3.3 Growth; 3.3.1 Concepts; 3.3.2 Importance; 3.3.3 Preclinical Measurements
  • 3.3.3.1 Rodents: In Vivo3.3.3.2 Rodents: Ex Vivo; 3.3.3.3 Non-rodents: In Vivo; 3.3.3.4 Non-rodents: Ex Vivo; 3.3.3.5 Data Interpretation; 3.4 Postnatal Therapies; 3.4.1 Anticancer Agents; 3.4.2 Retinoids; 3.4.3 Corticosteroids; 3.4.4 Anti-infectives; 3.4.5 CNS Therapies: Selective Serotonin Reuptake Inhibitors (SSRIs); 3.4.6 CNS Therapies: Antipsychotics; 3.4.7 Bisphosphonates; 3.4.8 Therapies to Affect Growth; 3.4.9 Bone Morphogenetic Protein; 3.4.10 Review of Agents
  • 3.5 Designs of Juvenile Toxicology Testing Programs for Pharmaceuticals and Biopharmaceuticals Where the Skeleton Is an Organ System of Concern3.5.1 Overview; 3.5.2 Program Design; 3.5.3 Species and Strain Selection; 3.5.4 Study Design; 3.6 Conclusions; References; Chapter 4: Animal Models in Bone Research; 4.1 Regulatory Guidelines for Animal Models of Osteoporosis; 4.2 A Perspective on In Vivo Experimentation; 4.3 Criteria for Animal Models in Osteoporosis; 4.3.1 Summary; 4.3.2 Postmenopausal Osteoporosis; 4.3.2.1 Growth and Adult Phases; 4.3.2.2 Role of Estrogen
Dimensions
unknown
Extent
1 online resource.
Form of item
online
Isbn
9783319561905
Specific material designation
remote
System control number
on1005188699

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