Description
Book SynopsisThe 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, regul
Table of 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,
RÉMI 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
