ABSTRACT

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.

chapter Chapter 6|38 pages

Value of Juvenile Toxicity Studies

chapter Chapter 7|51 pages

Photosafety Testing of Drugs