| Preface |
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iii | |
| Contributors |
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xi | |
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Regulatory Toxicology Testing: Laboratories and Good Laboratory Practices |
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1 | (14) |
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1 | (1) |
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Study Monitor/Sponsor Representative and the Audit |
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1 | (1) |
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Background of the Good Laboratory Practices |
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2 | (1) |
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Conducting the Preplacement Audit |
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3 | (5) |
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Case Study of Noncompliance |
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8 | (4) |
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12 | (1) |
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13 | (2) |
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Laboratory Animals and In Vitro Test Systems Used in Regulatory Toxicology |
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15 | (18) |
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15 | (1) |
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Use of Animals in Toxicology Testing |
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15 | (2) |
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Common Species in Regulatory Toxicology |
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17 | (9) |
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In Vitro Test Systems in Regulatory Toxicology Testing |
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26 | (3) |
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29 | (4) |
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33 | (46) |
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Background and Basic Principles |
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33 | (7) |
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Assessment of Major Organ Functions |
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40 | (19) |
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59 | (4) |
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63 | (1) |
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64 | (1) |
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65 | (14) |
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Metabolism and Toxicokinetics |
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79 | (30) |
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79 | (2) |
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Study Design and Study Parameters |
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81 | (11) |
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Data Evaluation and Interpretation |
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92 | (10) |
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102 | (2) |
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104 | (5) |
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Toxicologic Pathology Assessment |
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109 | (26) |
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109 | (1) |
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109 | (16) |
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125 | (5) |
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130 | (5) |
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135 | (14) |
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135 | (4) |
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139 | (3) |
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Dermal Irritation Studies |
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142 | (3) |
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145 | (1) |
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146 | (3) |
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Multidose General Toxicology Studies |
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149 | (36) |
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149 | (2) |
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Study Design and Study Parameters |
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151 | (12) |
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Data Reporting, Analysis, Interpretation, and Risk Assessment |
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163 | (11) |
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174 | (6) |
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180 | (1) |
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181 | (4) |
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185 | (64) |
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185 | (3) |
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Bacterial Mutation Assays |
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188 | (12) |
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Mammalian Cell Mutation Assays |
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200 | (7) |
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In Vitro Chromosome Aberration Assays |
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207 | (8) |
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In Vivo Cytogenetics Assay Systems |
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215 | (7) |
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Primary DNA Damage Assays |
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222 | (6) |
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Syrian Hamster Embryo Cell Transformation Assay |
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228 | (7) |
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Single Cell Gel Electrophoresis (Comet Assay) |
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235 | (1) |
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Implication of Positive Genetox Findings |
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236 | (3) |
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239 | (10) |
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249 | (16) |
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249 | (3) |
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Traditional Study Design and Parameters Measured |
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252 | (2) |
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Data Reporting, Analysis, Interpretation, and Risk Assessment |
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254 | (5) |
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Ongoing Issues and Future Trends |
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259 | (1) |
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259 | (6) |
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Juvenile Animal Toxicology Studies |
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265 | (40) |
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265 | (2) |
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Study Design and Study Parameters |
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267 | (19) |
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Data Reporting, Analysis, Interpretation, and Risk Assessment |
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286 | (7) |
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293 | (1) |
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294 | (11) |
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Developmental and Reproductive Toxicology |
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305 | (52) |
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305 | (3) |
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Study Design and Study Parameters |
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308 | (13) |
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Data Compilation, Interpretation, and Risk Assessment |
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321 | (15) |
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Additional Parameters to Measure and Other Follow-Up Studies |
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336 | (3) |
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339 | (1) |
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Appendix: Commonly Used Terms in Reproductive and Developmental Toxicity |
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339 | (10) |
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349 | (8) |
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357 | (34) |
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Introduction: What Is Neurotoxicity? |
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357 | (3) |
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Adult Neurotoxicity Testing: Study Design |
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360 | (6) |
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Developmental Neurotoxicity Testing: Study Design |
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366 | (9) |
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Data Collection, Reporting, Evaluation, and Interpretation |
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375 | (10) |
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385 | (1) |
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386 | (5) |
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Toxicological Assessment of the Immune System |
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391 | (26) |
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Introduction---Overview of the Immune System |
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391 | (3) |
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Immunosuppression, Hypersensitivity, and Autoimmunity |
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394 | (2) |
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Considerations and Approaches for Detecting Immunosuppression |
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396 | (2) |
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Dosing and Species Considerations |
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398 | (1) |
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Approaches to Evaluating Humoral Immunity |
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398 | (2) |
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Approaches to Evaluating Cellular Immunity |
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400 | (1) |
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Approaches to Evaluating Nonspecific Immunity: Macrophages, NK Cells, and Neutrophils |
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401 | (1) |
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Approaches to Evaluating Hypersensitivity Responses |
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402 | (1) |
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Developmental Immunotoxicity |
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403 | (1) |
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Immunomodulation in Human Populations |
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404 | (1) |
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Regulatory Issues in Immunotoxicology |
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405 | (5) |
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Conclusions/Further Directions |
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410 | (1) |
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411 | (6) |
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Inhalation and Pulmonary Toxicity Studies |
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417 | (22) |
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417 | (1) |
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Contracting an Inhalation Study |
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418 | (3) |
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421 | (6) |
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427 | (3) |
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430 | (2) |
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432 | (1) |
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Characterizing the Effects of Exposure |
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433 | (3) |
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The Report and Data Interpretation |
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436 | (1) |
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437 | (2) |
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Cancer Risk Assessment of Environmental Agents: Approaches to the Incorporation and Analysis of New Scientific Information |
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439 | (26) |
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439 | (3) |
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Hazard Identification/Hazard Characterization |
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442 | (8) |
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Dose-Response Assessment/Dose-Response Characterization |
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450 | (5) |
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Emerging Directions in Exposure Assessment |
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455 | (3) |
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458 | (1) |
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459 | (1) |
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460 | (5) |
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Nonclinical Safety Testing of Pharmaceuticals |
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465 | (14) |
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465 | (1) |
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Direction on the Timing of Toxicology Studies in Relation to Clinical Trials |
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466 | (2) |
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Studies Needed for Most New Drug Products |
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468 | (3) |
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471 | (1) |
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472 | (2) |
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Studies for Previously Approved Drugs |
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474 | (1) |
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The Value of Nonclinical Testing? |
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475 | (1) |
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Summary and Future Directions |
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476 | (1) |
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476 | (3) |
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Health Risk Assessment Strategies in the Food and Cosmetic Industry |
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479 | (12) |
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479 | (1) |
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479 | (9) |
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International Regulations |
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488 | (1) |
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489 | (1) |
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489 | (2) |
| Index |
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491 | |
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