Bone toxicology

• Other Authors: Smith, Susan Y. (Editor), Varela, Aurore (Editor), Samadfam, Rana (Editor)
• Format: Electronic eBook
• Language: English
• Published: Cham : Springer, ©2017.
• Series: Molecular and integrative toxicology.
• Subjects: Toxicology.; Bones.; elektronické knihy; electronic books
• ISBN: 9783319561929; 9783319561905
• Physical Description: 1 online resource

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 describ...

Table of 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.