Safety Evaluation of Pharmaceuticals and Medical Devices International Regulatory Guidelines
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...
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| Format: | eBook |
| Language: | English |
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New York, NY
Springer US
2011, 2011
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| Edition: | 1st ed. 2011 |
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| Online Access: | |
| Collection: | Springer eBooks 2005- - Collection details see MPG.ReNa |
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.