Safety Evaluation of Pharmaceuticals and Medical Devices International Regulatory Guidelines /

• Main Author: Gad, Shayne C. (Author)
• Corporate Author: SpringerLink (Online service)
• Format: Electronic eBook
• Language: English
• Published: Boston, MA : Springer US, 2011.
• Subjects: Medicine.; Pharmacy.; Pharmacology.; Pharmaceutical technology.; Biomedicine.; Pharmacology/Toxicology.; Pharmaceutical Sciences/Technology.

Safety Evaluation of Pharmaceuticals and Medical Devices has been written to provide complete, ready and clear guidance as to what nonclinical safety assessment tests need to be performed to move a regulated therapeutic medical product into and through the development process and to marketing approv...

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.