Main description:

The inaugural volume in the Current Topics in Nonclinical Drug Development Series explores the critical issues and current topics in nonclinical drug development. This first volume covers individual topics and strategies in drug development from compound characterization to drug registration. Written by a variety of experts in the field, recent and rapid advances in technologies and associated changes in regulatory guidance are discussed.

Additional features include:

Deals with day-to-day issues in study design, evaluation of findings, and presentation of data.

Explains new approaches in the development of medical devices.

Includes dedicated chapters on the use of bioinformatics in drug development.

Addresses strategies for photosafety testing of drugs.

Current Topics in Nonclinical Drug Development, Volume I will aid toxicologists, toxicologic pathologists, consultants, regulators, Study Directors, and nonclinical scientists dealing with day-to-day issues in study design, evaluation of findings, and presentation of data. In addition, the book will be a valuable reference for academicians and graduate students pursuing research related to nonclinical drug development.

Contents:

Contents

PREFACE VII

ACKNOWLEDGMENTS IX

EDITORS XI

CONTRIBUTORS XV

1 Bioinformatics/Impact of Computational Biology

for Molecular Safety Assessment during Drug

Development 1

JULIANE PERNER, MEGUMI ONISHI-SEEBACHER,

ALBERTO DEL RIO ESPINOLA, ELAINE TRITTO, PHILIPPE COUTTET,

REMI TERRANOVA, AND JONATHAN MOGGS

2 Integrating Toxicogenomics Data into Risk

Assessment 23

ARUN R. PANDIRI, WARREN CASEY, AND SCOTT S. AUERBACH

3 New Approaches in Development

of Medical Devices 53

SHANNON M. WALLACE, PEGGY A. LALOR,

AND KATHLEEN A. FUNK

4 Recent Advances in the Development

of Novel Biomarkers of Toxicity 81

DOMINIQUE BREES, DANA WALKER, DAVID LEDIEU,

DAVID BROTT MICHAEL MERZ, AND JACQUELINE TARRANT

5 Preclinical Evaluation and Translational

Development of Cell and Gene Therapies 121

SHON GREEN, TIMOTHY K. MACLACHLAN, JENNIFER L.

MARLOWE, AND PRASHANT NAMBIAR

6 Value of Juvenile Toxicity Studies 185

PAUL BALDRICK

7 Photosafety Testing of Drugs 223

ANTHONY M. LYNCH AND DANIEL BAUER

8 Combination Safety Assessment During Drug

Development 275

JOANNE BIRKEBAK, SHERRY L. RALSTON,

AND LEIGH ANN BURNS-NAAS

INDEX 307