Contents

pp v-vi

Contributors

pp vii-x

Prologue – Predictive toxicology: a new chapter in drug safety evaluation

pp xi-xii

PREDICTIVE TOXICOLOGY IN DRUG SAFETY

pp xiii-xiv

I - SPECIFIC AREAS OF PREDICTIVE TOXICOLOGY

1 - The human predictive value of combined animal toxicity testing: current state and emerging approaches

pp 1-17

2 - Screening approaches for genetic toxicity

pp 18-33

3 - Cardiac safety

pp 34-53

4 - Predicting drug-induced liver injury: safer patients or safer drugs?

pp 54-75

5 - In vitro evaluation of metabolic drug–drug interactions

pp 76-101

6 - Reliability of reactive metabolite and covalent binding assessments in prediction of idiosyncratic drug toxicity

pp 102-123

7 - Immunotoxicity: technologies for predicting immune stimulation, a focus on nucleic acids and haptens

pp 124-134

8 - Predictive models for neurotoxicity assessment

pp 135-152

9 - De-risking developmental toxicity-mediated drug attrition in the pharmaceutical industry

pp 153-182

II - INTEGRATED APPROACHES OF PREDICTIVE TOXICOLOGY

10 - Integrated approaches to lead optimization: improving the therapeutic index

pp 183-203

11 - Predictive toxicology approaches for small molecule oncology drugs

pp 204-229

12 - Mechanism-based toxicity studies for drug development

pp 230-243

13 - Fish embryos as alternative models for drug safety evaluation

pp 244-268

14 - The role of genetically modified mouse models in predictive toxicology

pp 269-283

15 - Toxicogenomic and pathway analysis

pp 284-301

16 - Drug safety biomarkers

pp 302-313

17 - Application of TK/PD modeling in predicting dose-limiting toxicity

pp 314-329

18 - Prediction of therapeutic index of antibody-based therapeutics: mathematical modeling approaches

pp 330-343

19 - Vaccine toxicology: nonclinical predictive strategies

pp 344-370

Epilogue

pp 371-374

Index

pp 375-389

Plate section