Inhaled pharmaceutical product development perspectives : challenges and opportunities /
Clasificación: | Libro Electrónico |
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Autor principal: | |
Formato: | Electrónico eBook |
Idioma: | Inglés |
Publicado: |
Amsterdam, Netherlands :
Elsevier,
[2018]
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Colección: | Emerging issues in analytical chemistry.
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Temas: | |
Acceso en línea: | Texto completo |
Tabla de Contenidos:
- Machine generated contents note: ch. 1 Introduction
- Historical Perspective
- Inhaled Products
- Scientific Advances
- Technical Advances
- Regulatory Advances
- Clinical Advances
- Conclusion
- References
- ch. 2 Dosage Forms
- Metered Dose Inhalers
- Dry Powder Inhalers
- Nebulizers
- Other Products
- Specialized Formulations
- Manufacturing
- Performance Criteria
- Conclusion
- References
- ch. 3 Quality and Performance Tests
- Physical Tests for Drug and Excipient Characterization
- Aerodynamic Particle Size Distribution
- Delivered Dose and Uniformity
- Other Factors
- IVIVC Considerations
- Statistical Parameters
- Stability
- Conclusion
- References
- ch. 4 Preclinical and Clinical Considerations
- Lung Deposition Imaging
- Lung Deposition Modeling
- Animal Models
- Cell Culture
- Pharmacokinetics
- Pharmacodynamics
- Conclusion
- References
- ch. 5 Regulatory Strategy
- International Regulations
- United States Regulations
- General Principles
- Conclusion
- References
- ch. 6 General Conclusion
- Diseases
- Dosage Forms
- Quality and Performance Tests
- Preclinical and Clinical Considerations
- Regulatory Strategy
- New Disease Targets.