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Biosimilars : Design and Analysis of Follow-on Biologics.
As many biological products face losing their patents in the next decade, the pharmaceutical industry needs an abbreviated regulatory pathway for approval of biosimilar drug products, which are cost-effective, follow-on/subsequent versions of the innovator's biologic products. But scientific ch...
| Clasificación: | Libro Electrónico |
|---|---|
| Autor principal: | |
| Formato: | Electrónico eBook |
| Idioma: | Inglés |
| Publicado: |
Hoboken :
CRC Press,
2013.
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| Colección: | Chapman & Hall/CRC biostatistics series.
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| Temas: | |
| Acceso en línea: | Texto completo |
Tabla de Contenidos:
- Front Cover; Contents; Preface; Chapter 1
- Introduction; Chapter 2
- Bioequivalence Experience for Small-Molecule Drug Products; Chapter 3
- Regulatory Requirements for Assessing Follow-on Biologics; Chapter 4
- Criteria for Similarity; Chapter 5
- Statistical Methods for Assessing Average Biosimilarity; Chapter 6
- General Approach for Assessing Biosimilarity; Chapter 7
- Non-Inferiority versus Equivalence/Similarity; Chapter 8
- Statistical Test for Biosimilarity in Variability; Chapter 9
- Sample Size for Comparing Variabilities.
- Chapter 10
- Impact of Variability on Biosimilarity Limits for Assessing Follow-on BiologicsChapter 11
- Drug Interchangeability; Chapter 12
- Issues on Immunogenicity Studies; Chapter 13
- CMC Requirements for Biological Products; Chapter 14
- Test for Comparability in Manufacturing Process; Chapter 15
- Stability Analysis of Biosimilar Products; Chapter 16
- Assessing Biosimilarity Using Biomarker Data; Chapter 17
- Current Issues in Biosimilar Studies; References; Back Cover.