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FDA Bioequivalence Standards
This comprehensive reference provides an in-depth discussion on state-of-the-art regulatory science in bioequivalence. In sixteen chapters, the volume explores a broad range of topics pertaining to bioequivalence, including its origin and principles, statistical considerations, food effect studies,...
| Clasificación: | Libro Electrónico |
|---|---|
| Autor Corporativo: | |
| Otros Autores: | , |
| Formato: | Electrónico eBook |
| Idioma: | Inglés |
| Publicado: |
New York, NY :
Springer New York : Imprint: Springer,
2014.
|
| Edición: | 1st ed. 2014. |
| Colección: | AAPS Advances in the Pharmaceutical Sciences Series,
13 |
| Temas: | |
| Acceso en línea: | Texto Completo |
Tabla de Contenidos:
- 1 Bioequivalence History
- 2 Fundamentals of Bioequivalence
- 3 Basic Statistical Considerations
- 4 The Effects of Food on Drug Bioavailability and Bioequivalence
- 5 Bio waiver and Biopharmaceutics Classification System
- 6 Bioequivalence of Highly Variable Drugs
- 7 Partial Area under the Curve: An Additional Pharmacokinetic Metric for Bioavailability and Bioequivalence Assessments
- 8 Bioequivalence for Narrow Therapeutic Index Drugs
- 9 Pharmacodynamic Endpoint-based Bioequivalence Studies
- 10 Clinical Endpoint Bioequivalence Study
- 11 Bioequivalence for Liposomal Drug Products
- 12 Bioequivalence for Drug Products Acting Locally within Gastrointestinal Tract
- 13 Bioequivalence for Topical Drug Products
- 14 Bioequivalence for Orally Inhaled and Nasal Drug Products
- 15 Bioequivalence: Modeling and Simulation
- 16 Bioanalysis.