9780781740104

Written by leading investigators from academia and the pharmaceutical industry, this volume is a comprehensive, practical guide for all researchers involved in anticancer drug development. The book covers the entire field from preclinical research, through clinical trials, to licensure requirements in the United States and in the European Union. Chapters address drug discovery, preclinical models, drug measurement, delivery systems, Phase I trial design, and Phase II-III testing. The book provides state-of-the-art coverage of contemporary drug design concepts, in vitro models, new assay methodologies, good manufacturing practice criteria in the US and EU, and new methods for testing anticancer agents in humans.

Introduction

ix

Contributing Authors

xi

Part 1: Introduction

1. How Oncology Drug Development Differs from Other Fields

3

(10)

Ann T. Farrell, John Leighton, Grant Williams, and Richard Pazdur

Part 2: Drug Discovery

2. Natural Products

13

(12)

Riyaz N.H. Shah and Stanley B. Kaye

3. History of the National Cancer Institute Drug Discovery Program

25

(18)

Edward A. Sausville and Jill I. Johnson

4. Combinatorial Chemistry in Anticancer Drug Development

43

(14)

Ian R. Hardcastle and Roger J. Griffin

5. Protein Crystallography in Drug Discovery

57

(12)

Martin Noble and Jane Endicott

6. High-Throughput Screening

69

(10)

Ramesh Padmanabha and Martyn Banks

7. Bioinformatics and Data Mining in Support of Drug Discovery

79

(18)

Jeffrey Augen

8. Genomics and Drug Development

97

(20)

Robert H. tePoele and Paul Workman

9. The Application of Proteomics to Drug Development

117

(12)

Lasantha R. Bandara and Sandy Kennedy

Part 3: Preclinical Models

10. The Role of In Vitro Cell Line, Human Xenograft, and Mouse Allograft Models in Cancer Drug Development

129

(20)

Theodora Voskoglou-Nomikos, Stefan D. Baral, and Lesley K. Seymour

11. Drug-Drug Interaction Studies During Early Clinical Drug Development

149

(14)

Jochen Kuhlmann and Christoph Wandel

12. Gene-Targeted Mice in Anticancer Drug Development

163

(24)

Thomas M. Donnelly

Part 4: Analytical Laboratory Techniques

13. Modern and Practical Guide for Bioanalysis

187

(8)

Surendra K. Bansal and Zhenmin Liang

14. Good Laboratory Practice and the Development of Anticancer Agents

195

(10)

Jinee D. Rizzo

Part 5: Delivery Systems

15. Pharmaceutical Formulation of Novel Anticancer Agents

205

(20)

Bastiaan Nuijen

16. Liposomal Drug Carriers for Cancer Diagnosis and Therapy

225

(14)

Martin Brandi

17. Polymer-Drug Conjugates

239

(22)

Ruth Duncan

18. Prodrug Drug Development and Retrometabolic Engineering

261

(8)

Daniel R. Budman

19. Pharmacokinetics and Pharmacodynamics in Anticancer Drug Development

269

(16)

Chris H. Takimoto

Part 6: Clinical Studies

20. Allometric Scaling: Predicting Pharmacokinetic Parameters of Drugs in Humans from Animal

285

(12)

Iftekhar Mahmood

21. Phase I Clinical Trial Design

297

(12)

Lawrence V. Rubinstein and Richard M. Simon

22. Phase I Trial Design: Considerations in the Pediatric Population

309

(10)

Elizabeth Fox and Peter C. Adamson

23. Measurements of Endpoints in Phase I Drug Design: Toxicity versus Alternatives

319

(12)

Jerry M. Collins and Merrill J. Egorin

24. Tumor Response Evaluation in Clinical Trials: RECIST

331

(12)

A. Dimitrios Colevas

25. Pharmacogenetics and Cancer Chemotherapy

343

(36)

Hany Ezzeldin and Robert B. Diasio

26. Designs for Phase II and Phase III Cancer Drug Studies

379

(16)

Gary L. Rosner and Donald A. Berry

Part 7: Specific Issues in Drug Development

27. Data Verification and Scientific Auditing

395

(8)

Raymond B. Weiss

28. Role of the Cooperative Groups in Drug Development

403

(8)

Christopher W. Ryan and Richard L. Schilsky

29. Drug Development in the Elderly

411

(14)

Stuart M. Lichtman

30. Quality-of-Life Measurement

425

(8)

Delly Dineen, David Cella, and Kimberly Davis

31. Development of Supportive Care Agents in Oncology

433

(8)

Scott Z. Fields and Alessandra Cesano

32. Cancer Vaccines

441

(12)

Howard Z. Streicher, Adriana A. Byrnes, and Jay J. Greenblatt

Part 8: Licensure Issues

33. Regulatory Requirements for Licensure: United States and Europe

453

(10)

Elaine Meaker, Bruce Feistner, and Nicole Onetto

INDEX

463

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Handbook of Anticancer Drug Development

078174010X

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