| Description |
1 online resource (1245 pages) |
| Contents |
Cover; Half Title; Title Page; Copyright Page; Table of Contents; Preface; Acknowledgments; Editors; Contributors; Section I : Concepts in Drug Development; Chapter 1: Overview of Drug Development; 1.1 Scientific History; 1.1.1 Origin of Modern Therapeutic Agents; 1.2 Regulatory History; 1.2.1 Regulatory Aspects of Drug Development; 1.2.2 US Food and Drug Law; 1.2.3 European Drug Law; 1.2.4 Japanese Drug Law; 1.2.5 International Harmonization; 1.2.6 Current Regional Regulatory Differences; 1.2.7 Regulatory Review Process; 1.3 Sequence of Small-Molecule Drug Development |
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1.3.1 Selection of Areas for Drug Development1.3.2 Scientific Expertise Required for Drug Development; 1.3.3 Stages of Drug Development; 1.3.4 Drug Discovery; 1.3.5 Nonclinical Development; 1.3.6 Clinical Development; 1.3.7 Postmarketing; 1.3.8 Decision Process for Advancement or Termination during Drug Development; 1.3.9 Role and Responsibility of Toxicologic Pathologist in Drug Development; 1.4 Approaches to Drug Development of Biotherapeutics; 1.4.1 Approaches to Drug Development of Oligodeoxynucleotide Therapeutics; 1.4.2 Approaches to Drug Development of Gene Therapy Products |
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1.5 Time and Resource Utilization in Drug Development1.6 Future Changes in Drug Development; References; Chapter 2: Nonclinical Safety Evaluation of Drugs; 2.1 Introduction; 2.2 Lead Optimization Safety Assessment; 2.3 Nonclinical Animal Toxicology Studies for Small Molecules; 2.4 Nonclinical Animal Toxicology Studies for Biopharmaceuticals; 2.5 Reversibility/Recovery of Drug-Induced Pathology in Nonclinical Safety Studies; 2.6 Comparing Biopharmaceuticals to Traditional Small-Molecule Drugs; 2.7 Immunotoxicology; 2.8 Safety Pharmacology; 2.9 Development and Reproductive Toxicology |
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2.10 Genetic Toxicology2.11 Carcinogenicity Testing; 2.12 Safety Assessment of Oncology Products; 2.13 Challenges with Nonclinical Safety Assessment in the NHP; 2.14 Reporting Pathology Data for the Regulatory Scientist and Clinician; References; Chapter 3: Nonclinical Safety Evaluation of Advanced Therapies; 3.1 Introduction; 3.2 Cell-based Therapies; 3.2.1 Types; 3.2.2 Safety Concerns; 3.3 Gene Therapies; 3.3.1 Ex Vivo Gene Therapies/Genetically Modified Cell Therapies; 3.3.2 In Vivo Gene Therapies; 3.3.3 T-Cell Based Immunotherapy; 3.3.4 Genome Editing; 3.3.5 Oncolytic Viruses |
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3.4 Expression Knockdown Therapies3.4.1 Introduction to Expression Knockdown Therapies; 3.4.2 Accumulation Effects: Basophilic Granules and Vacuolated Macrophages; 3.4.3 Proinflammatory Effects; 3.4.4 Renal Effects; 3.4.5 Liver Toxicity; 3.4.6 Thrombocytopenia; 3.4.7 Newer Generation ASO Modalities; 3.5 US FDA/CBER Regulatory Perspective on Cellular and Gene Therapies; References; Chapter 4: Nonclinical Safety Evaluation of Medical Devices; 4.1 Introduction; 4.2 Knowledge Base and Scientific Interactions; 4.3 In Vivo Biological Evaluation of Biomaterials and Medical Devices; 4.4 Terminology |
| Summary |
Following the success of the first edition, this book is designed to provide practical and timely information for toxicologic pathologists working in pharmaceutical drug discovery and development. The majority of the book (Organ Systems) will provide detailed descriptions of histopathological lesions observed in drug development. In addition, it will provide information to assist the pathologist in making determinations of the origin of lesions as well as its relevance to human risk. Toxicologic Pathology: Nonclinical Safety Assessment, Second Edition includes 2 new concept chapters. The first of the new chapters address approaches for the evaluation of unique therapeutic modalities such as cell therapies, gene therapies, and gene expression knockdown therapies. While these still represent new developing therapeutic approaches, there has been significant experience with the therapeutic modalities in the last 5 years. The second new chapter addresses the nonclinical safety assessment of medical devices, a topic of increasing importance that was not addressed in a unique chapter in the first edition. The other concept chapters have been updated and cover important topics including the overview of drug development; principles of nonclinical safety assessment; an introduction to toxicologic pathology; techniques used in toxicologic pathology, clinical pathology, toxicokinetics, and drug development toxicogenomics; and spontaneous lesions. The 13 organ system chapters provide the specifics related to pathologic characteristics, differential diagnosis, and interpretation of toxic responses in each organ system. These chapters are specifically important for the bench pathologist but also for the toxicologist who interacts with pathologists and function as study toxicologists and project team representatives in the drug development arena |
| Notes |
4.4.1 Biomaterials |
| Bibliography |
Includes bibliographical references and index |
| Notes |
Print version record |
| Subject |
Drugs -- Testing.
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Risk assessment.
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Toxicity testing.
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Drug Evaluation, Preclinical
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Risk Assessment
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Toxicity Tests
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Clinical Trials as Topic
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risk assessment.
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MEDICAL -- Pharmacology.
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MEDICAL -- Toxicology.
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Drugs -- Testing
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Risk assessment
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Toxicity testing
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| Form |
Electronic book
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| Author |
Popp, James A
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Hardisty, Jerry F
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Gopinath, Chirukandath
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Bouchard, Page
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| ISBN |
9780429997464 |
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0429997469 |
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9780429504624 |
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0429504624 |
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