Safety Evaluation of Pharmaceuticals and Medical Devices : International Regulatory Guidelines /
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| Format: | eBook |
| Language: | English |
| Published: |
New York, NY :
Springer US : Imprint: Springer,
2011.
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| Edition: | 1st ed. 2011. |
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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.