7.1 Introduction 106

7.1.1 Physicochemical Characterization 106

7.1.2 In Vitro Characterization 107

7.1.3 In Vivo Characterization 107

7.2 Physicochemical Characterization 107

7.2.1 Physicochemical Characterization Strategies 108

7.2.2 Instrumentation 108 Spectroscopy 108 Chromatography 109 Microscopy 109 Size and Size Distribution 110 Surface Characteristics 112 Functionality 112 Composition and Purity 113 Stability 114

7.3 In Vitro Pharmacological and Toxicological Assessments 115

7.3.1 Special Considerations 115

7.3.2 In Vitro Target-Organ Toxicity 116

7.3.3 Cytotoxicity 117

7.3.4 Oxidative Stress 118

7.3.5 Apoptosis and Mitochondrial Dysfunction 119

7.3.6 Proteomics and Toxicogenomics 121

7.4 In Vivo Pharmacokinetic and Toxicological Assessments 121

7.5 Immunotoxicity 124

This project has been funded in whole or in part with federal funds from the National Cancer Institute, National Institutes of Health, under contract N01-C0-I2400. The content of this publication does not necessarily reflect the views or policies of the Department of Health and Human Services, nor does mention of trade names, commercial products, or organizations imply endorsement by the U.S. Government.

7.5.1 Applicability of Standard Immunological Methods for Nanoparticle Evaluation and Challenges Specific to Nanoparticle Characterization Blood Contact Properties

7.5.2 Immunogenicity

7.6 Conclusions


125 125 128 128 129

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