Toxicological Testing Handbook: Principles, Applications and Data Interpretation

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ISBN: 9780849338588 | 0849338581
Cover: Hardcover
Copyright: 7/11/2006

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Furnishing essential data on all areas of toxicity testing, this Second Edition provides guidance on the design and evaluation of product safety studies to help ensure regulatory acceptance. Every chapter highlights regulatory requirements specific to the United States, Europe, and Japan, and in addition to expanded information on data interpretation, hazard assessment, carcinogenicity studies, and Good Laboratory Practices, new chapters regarding safety pharmacology, juvenile studies, the health safety assessment of pharmaceuticals, and health assessment strategies in the food and cosmetic industry have been added to reflect changes to regulatory requirements. Toxicological Testing Handbook, Second Edition is a must-have reference for individuals responsible for assuring the safety of new pharmaceutical, biotechnical, and chemical products and materials.

Preface

iii

Contributors

Regulatory Toxicology Testing: Laboratories and Good Laboratory Practices

(14)

Linda J. Frederick

Introduction

(1)

Study Monitor/Sponsor Representative and the Audit

(1)

Background of the Good Laboratory Practices

(1)

Conducting the Preplacement Audit

(5)

Case Study of Noncompliance

(4)

Conclusion

(1)

References

(2)

Laboratory Animals and In Vitro Test Systems Used in Regulatory Toxicology

(18)

Kit A. Keller

Introduction

(1)

Use of Animals in Toxicology Testing

(2)

Common Species in Regulatory Toxicology

(9)

In Vitro Test Systems in Regulatory Toxicology Testing

(3)

References

(4)

Safety Pharmacology

(46)

William S. Redfern

Ian D. Wakefield

Background and Basic Principles

(7)

Assessment of Major Organ Functions

(19)

Advanced Topics

(4)

Future Trends

(1)

Concluding Remarks

(1)

References

(14)

Metabolism and Toxicokinetics

(30)

J. Caroline English

Introduction

(2)

Study Design and Study Parameters

(11)

Data Evaluation and Interpretation

(10)

Current Applications

102

(2)

References

104

(5)

Toxicologic Pathology Assessment

109

(26)

Lynda L. Lanning

Introduction

109

(1)

Clinical Pathology

109

(16)

Morphologic Pathology

125

(5)

References

130

(5)

Acute Toxicology

135

(14)

Elmer J. Rauckman

Andrew I. Soiefer

Acute Toxicity Studies

135

(4)

Eye Irritation Studies

139

(3)

Dermal Irritation Studies

142

(3)

Testing Strategies

145

(1)

References

146

(3)

Multidose General Toxicology Studies

149

(36)

Kit A. Keller

Christopher Banks

Introduction

149

(2)

Study Design and Study Parameters

151

(12)

Data Reporting, Analysis, Interpretation, and Risk Assessment

163

(11)

Target Organs

174

(6)

Future Trends

180

(1)

References

181

(4)

Genetic Toxicology

185

(64)

Donald L. Putman

Jane J. Clarke

Patricia Escobar

Ramadevi Gudi

Ljubica S. Krsmanovic

Kamala Pant

Valentine O. Wagner III

Richard H. C. San

David Jacobson-Kram

Introduction

185

(3)

Bacterial Mutation Assays

188

(12)

Mammalian Cell Mutation Assays

200

(7)

In Vitro Chromosome Aberration Assays

207

(8)

In Vivo Cytogenetics Assay Systems

215

(7)

Primary DNA Damage Assays

222

(6)

Syrian Hamster Embryo Cell Transformation Assay

228

(7)

Single Cell Gel Electrophoresis (Comet Assay)

235

(1)

Implication of Positive Genetox Findings

236

(3)

References

239

(10)

Carcinogenicity Studies

249

(16)

Abigail C. Jacobs

Introduction

249

(3)

Traditional Study Design and Parameters Measured

252

(2)

Data Reporting, Analysis, Interpretation, and Risk Assessment

254

(5)

Ongoing Issues and Future Trends

259

(1)

References

259

(6)

Juvenile Animal Toxicology Studies

265

(40)

Kok Wah Hew

Introduction

265

(2)

Study Design and Study Parameters

267

(19)

Data Reporting, Analysis, Interpretation, and Risk Assessment

286

(7)

Conclusion

293

(1)

References

294

(11)

Developmental and Reproductive Toxicology

305

(52)

Kit A. Keller

Introduction

305

(3)

Study Design and Study Parameters

308

(13)

Data Compilation, Interpretation, and Risk Assessment

321

(15)

Additional Parameters to Measure and Other Follow-Up Studies

336

(3)

Conclusion

339

(1)

Appendix: Commonly Used Terms in Reproductive and Developmental Toxicity

339

(10)

References

349

(8)

Neurotoxicology Testing

357

(34)

Kathleen C. Raffaele

Walter P. Weisenburger

Introduction: What Is Neurotoxicity?

357

(3)

Adult Neurotoxicity Testing: Study Design

360

(6)

Developmental Neurotoxicity Testing: Study Design

366

(9)

Data Collection, Reporting, Evaluation, and Interpretation

375

(10)

Conclusion

385

(1)

References

386

(5)

Toxicological Assessment of the Immune System

391

(26)

Dori R. Germolec

Robert W. Luebke

Robert V. House

Gary J. Rosenthal

Introduction---Overview of the Immune System

391

(3)

Immunosuppression, Hypersensitivity, and Autoimmunity

394

(2)

Considerations and Approaches for Detecting Immunosuppression

396

(2)

Dosing and Species Considerations

398

(1)

Approaches to Evaluating Humoral Immunity

398

(2)

Approaches to Evaluating Cellular Immunity

400

(1)

Approaches to Evaluating Nonspecific Immunity: Macrophages, NK Cells, and Neutrophils

401

(1)

Approaches to Evaluating Hypersensitivity Responses

402

(1)

Developmental Immunotoxicity

403

(1)

Immunomodulation in Human Populations

404

(1)

Regulatory Issues in Immunotoxicology

405

(5)

Conclusions/Further Directions

410

(1)

References

411

(6)

Inhalation and Pulmonary Toxicity Studies

417

(22)

Raymond M. David

Introduction

417

(1)

Contracting an Inhalation Study

418

(3)

Study Design

421

(6)

The Test Substance

427

(3)

The Test System

430

(2)

Exposure Systems

432

(1)

Characterizing the Effects of Exposure

433

(3)

The Report and Data Interpretation

436

(1)

References

437

(2)

Cancer Risk Assessment of Environmental Agents: Approaches to the Incorporation and Analysis of New Scientific Information

439

(26)

William H. Farland

William P. Wood

Kerry L. Dearfield

Introduction

439

(3)

Hazard Identification/Hazard Characterization

442

(8)

Dose-Response Assessment/Dose-Response Characterization

450

(5)

Emerging Directions in Exposure Assessment

455

(3)

Risk Characterization

458

(1)

Summary

459

(1)

References

460

(5)

Nonclinical Safety Testing of Pharmaceuticals

465

(14)

Amy L. Ellis

Kenneth L. Hastings

Introduction

465

(1)

Direction on the Timing of Toxicology Studies in Relation to Clinical Trials

466

(2)

Studies Needed for Most New Drug Products

468

(3)

Carcinogenicity Testing

471

(1)

Special Studies

472

(2)

Studies for Previously Approved Drugs

474

(1)

The Value of Nonclinical Testing?

475

(1)

Summary and Future Directions

476

(1)

References

476

(3)

Health Risk Assessment Strategies in the Food and Cosmetic Industry

479

(12)

Steven M. Weisman

Linnea Steiger

Introduction

479

(1)

History

479

(9)

International Regulations

488

(1)

Future Trends

489

(1)

References

489

(2)

Index

491

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Toxicological Testing Handbook: Principles, Applications and Data Interpretation

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Table of Contents

Supplemental Materials