Sterile Product Development : Formulation, Process, Quality and Regulatory Considerations /
| Autor Corporativo: | |
|---|---|
| Otros Autores: | , , |
| Formato: | eBook |
| Lenguaje: | English |
| Publicado: |
New York, NY :
Springer New York : Imprint: Springer,
2013.
|
| Edición: | 1st ed. 2013. |
| Colección: | AAPS Advances in the Pharmaceutical Sciences Series,
6 |
| Materias: |
Tabla de Contenidos:
- Basic Principles of Sterile Product Formulation Development
- Molecule and Manufacturability Assessment Leading to Robust Commercial Formulation for Therapeutic Proteins
- Polymer and Lipid Based Systems for Parenteral Drug Delivery
- Formulation Approaches and Strategies for PEGylated Biotherapeutics
- Nasal Delivery
- Formulation Approaches and Strategies for Vaccines and Adjuvants
- Challenges in Freeze-Thaw Processing of Bulk Protein Solutions
- Best Practices for Technology Transfer of Sterile Products: Case Studies
- Transfer Across Barrier Systems: A New Source of Simplification in Aseptic Fill and Finish Operations
- Challenges and Innovation in Aseptic Filling: Case Study with the Closed Vial Technology
- Contemporary Approaches to Development and Manufacturing of Lyophilized Parenterals
- Advances in Container Closure Integrity Testing
- Pen and Autoinjector Drug Delivery Devices
- Particulate Matter in Sterile Parenteral Products
- Appearance Evaluation of Parenteral Pharmaceutical Products
- Sterile Filtration Principles, Best Practices and New Developments
- Intravenous Admixture Compatibility for Sterile Products: Challenges and Regulatory Guidance
- Basics of Sterilization Methods
- Avoiding Common Errors during Viable Microbial Contamination Investigations
- Validation of Rapid Microbiology Methods (RMMs)
- Validation of Moist and Dry Heat Sterilization.