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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...
| Clasificación: | Libro Electrónico |
|---|---|
| Autor principal: | |
| Autor Corporativo: | |
| Formato: | Electrónico eBook |
| Idioma: | Inglés |
| Publicado: |
New York, NY :
Springer US : Imprint: Springer,
2011.
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| Edición: | 1st ed. 2011. |
| Temas: | |
| Acceso en línea: | Texto Completo |
Tabla de Contenidos:
- 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.