Pharmaceutical inhalation aerosol technology / [edited by] Anthony J. Hickey, Sandro R. da Rocha.
1. Introduction -- Section I Discovery (pharmacology/physiology/anatomy, etc) -- 2. Physiology of the Airways -- 3. Drug Targeting to the Lung: Chemical and Biochemical Considerations -- Section II Aerosol Critical Attributes (aerodynamic behavior, lung deposition, and clearance) -- 4. Aerosol Physics and Lung Deposition Modelling -- 5. Practical Aspects of Imaging Techniques Employed to Study Aerosol Deposition and Clearance -- 6. Pharmacokinetics and Pharmacodynamics of Drugs Delivered to the Lung -- Section III Active Pharmaceutical -- Ingredient/Drug Product Manufacturing -- 7 Small Molecules: Process Intensification and Continuous Synthesis -- 8 Biologic Drug Substance and Drug Product Manufacture -- 9 Scale-Up Considerations for Orally Inhaled Drug Products -- 10 Quality by Control -- Section IV Particle Engineering/Processing (milling/blending, spray drying, supercritical fluid, nano, etc.) -- 11. Milling and Blending: Producing the Right Particles and Blend Characteristics for Dry Powder Inhalation -- 12. Engineering Stable Spray Dried Biologic Powder for Inhalation -- 13 Supercritical Fluid Manufacture -- 14 Particle Engineering Technology for Inhaled Therapies -- Section V Drug Product Formulation -- 15 Emerging Pulmonary Delivery Strategies in Gene Therapy: State of the Art and Future Considerations -- 16 Genome Editing for Genetic Lung Diseases -- 17 Inhalation Drug Products Containing Nanomaterials -- Section VI Devices (design and performance) -- 18. Pressurized Metered-Dose Inhalers -- 19. Dry Powder Inhalation -- 20. Nebulisers -- 21. Soft Mist Sprays -- Section VII Drug Product Testing (physico-chemical properties, aerodynamic particle size, delivered dose, etc.) -- 22 Quality by Design Considerations -- 23 Solid State Testing of Inhaled Formulations -- 24 Aerodynamic Particle Size Testing -- Section VIII Regulatory Considerations (CMC) -- 25. Scanning the Intricate Regulatory Landscape and Trying to Peek Over the Horizon -- 26. Pharmacopeial and Regulatory Guidances on Product Quality and Performance -- 27. The European Union Regulatory Scene -- Section IX Preclinical Testing (dosing for cells and animals) -- 28. Cell- and Tissue-Based (Reconstituted) 2D In Vitro Models to Study Drug Transport Processes across the Air-Blood Barrier -- 29. 3D In Vitro/Ex Vivo Systems -- 30. Preclinical Models for Pulmonary Drug Delivery -- Section X Clinical Testing (concepts of bioequivalence) -- 31. Bioequivalence of Orally-Inhaled Drug Products: Challenges and Opportunities -- 32. General Conclusions -- Index..
Medienart: |
E-Book |
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Erscheinungsjahr: |
[2019] |
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Erschienen: |
Boca Raton, Florida: CRC Press, ; 2019 |
Ausgabe: |
Third edition. |
Reihe: |
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Sprache: |
Englisch |
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Beteiligte Personen: |
Hickey, Anthony J., 1955- [HerausgeberIn] |
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Links: |
www.taylorfrancis.com [lizenzpflichtig] |
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ISBN: |
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Themen: |
Administration, Inhalation |
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Umfang: |
1 online resource ; illustrations. |
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doi: |
10.1201/9780429055201. |
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funding: |
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Förderinstitution / Projekttitel: |
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PPN (Katalog-ID): |
1678226440 |
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