| Description |
1 online resource (337 p.) |
| Series |
Current Topics in Nonclinical Drug Development Ser |
|
Current Topics in Nonclinical Drug Development Ser
|
| Contents |
Cover -- Half Title -- Series Page -- Title Page -- Copyright Page -- Table of Contents -- Preface -- Acknowledgments -- Editors -- Contributors -- 1 Bioinformatics/Impact of Computational Biology for Molecular Safety Assessment During Drug Development -- 1.1 Introduction -- 1.1.1 Safety Genetics Applications -- 1.1.2 Safety "Omics" Applications -- 1.2 Practical Computational Biology Considerations -- 1.3 Future Directions and Challenges -- References -- 2 Integrating Toxicogenomics Data Into Risk Assessment -- 2.1 Introduction to Chemical and Drug Risk Assessment |
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2.2 Introduction to Toxicogenomic Technologies -- 2.3 Specific Areas of Application -- 2.3.1 Using Toxicogenomics to Derive a Biological Effect Point of Departure -- 2.3.2 Prediction of Toxicity and Carcinogenicity -- 2.3.3 Characterizing Mode of Action -- 2.3.4 Characterizing Differences between Test Systems -- 2.3.5 In Vitro Toxicity Assessment -- 2.3.6 Genotoxicity and Mutation Spectra Characterization -- 2.3.7 Identifying Genomic Risk Factors for Increased Susceptibility to Chemical Exposure -- 2.3.8 Development of Adverse Outcome Pathways |
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2.4 Applications of Toxicogenomics at Different Stages of the Drug Development Pipeline -- 2.4.1 Toxicogenomics in Preclinical Studies -- 2.4.2 Pharmacogenomics in Clinical Studies -- 2.5 Summary and Conclusions -- Reference -- 3 New Approaches in Development of Medical Devices -- 3.1 Introduction -- 3.2 Device Inception and Regulatory Strategy -- 3.2.1 USA Device Classification and Marketing -- 3.2.2 Other Global Classifications and Marketing -- 3.3 Medical Device Testing -- 3.3.1 Test Selection and Sequence of Testing -- 3.3.2 Considerations for Test Selection and Test Conduct |
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3.3.3 Contract Research Organizations: Testing from Device Inception to Marketing -- 3.4 Necropsy Considerations and Postmortem Planning for Histopathology -- 3.4.1 Histopathologic Analysis -- 3.4.2 Specialized Pathology Techniques -- 3.5 Data -- 3.5.1 Integration of Nonclinical and Clinical Trial Data -- 3.5.2 How to Avoid Common Data Package Problems -- 3.5.3 Harmonization between Agencies and SEND Data -- 3.5.4 Postmarket Concerns -- 3.6 Conclusion -- References -- 4 Recent Advances in The Development of Novel Biomarkers of Toxicity -- 4.1 Introduction -- 4.2 Path to Regulatory Acceptance |
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4.2.1 Assay Development and Validation, Regulatory Device Approval -- 4.2.2 Regulatory Qualification Guidance -- 4.2.3 Current Biomarker Initiatives -- 4.2.3.1 Predictive Safety Testing Consortium -- 4.2.3.2 FNIH Biomarker Consortium -- 4.2.3.3 TransBioLine -- 4.3 Future of Safety Biomarkers -- 4.3.1 Descriptive Safety Biomarkers -- 4.3.2 Advances in Nontraditional Safety Biomarkers -- 4.3.2.1 Immunoassay: Ultrasensitive Methods (e.g., Single Molecule Counting) -- Small Volume-Multiplexing, Microfluidic (Lateral Flow) -- Rapid Tests -- POC Tests -- 4.3.2.2 Aptamer Assays |
| Notes |
Description based upon print version of record |
|
4.3.2.3 Mass Spectrometry |
| Form |
Electronic book
|
| Author |
Bentley, Philip
|
|
Wojcinski, Zbigniew
|
| ISBN |
9780429651137 |
|
0429651139 |
|
