Safety Evaluation of Pharmaceuticals and Medical Devices : International Regulatory Guidelines /

Bibliographic Details
Main Author: Gad, Shayne C. (Author)
Corporate Author: SpringerLink (Online service)
Format: eBook
Language:English
Published: New York, NY : Springer US : Imprint: Springer, 2011.
Edition:1st ed. 2011.
Subjects:
Table of Contents:
  • Preface
  • Introduction to Safety Assessment in Drug and Medical Device Development
  • Drugs: The General Case
  • Ind Enabling Toxicology Programs
  • Nonclinical Safety Evaluation Studies Conducted To Support Continued Clinical Development
  • Supporting Marketing Applications
  • Special Therapeutic Category And Route Of Administration Cases
  • Device Safety Evaluation
  • Appendix A
  • INDEX.