Inhaled Pharmaceutical Product Development Perspectives by Anthony J. HickeyInhaled Pharmaceutical Product Development Perspectives by Anthony J. Hickey

Inhaled Pharmaceutical Product Development Perspectives

byAnthony J. Hickey

Paperback | September 1, 2017

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Inhaled Pharmaceutical Product Development Perspectivesdescribes methods and protocols for developing inhaled pharmaceuticals while commenting on product development strategies and their suitability to support regulatory submission. It fills the gap between the aspirations of scientists invested in new technology development and the reality of the requirements that must be met for any new product to be commercialized.

The book brings together emerging analytical and inhalation technologies in a way that provides a unique perspective on formulation and device design, development, regulatory compliance and practice. Focusing on underlying scientific and technical principles known to be acceptable from the current regulatory perspective, this monograph will remain useful as a high-level guide to inhaled product development for the foreseeable future.



  • Focuses on underlying scientific and technical principles known to be acceptable from the current regulatory perspective
  • Discusses development strategies and best practices to support regulatory submissions
  • Written by an experienced expert and draws on the knowledge and critical opinions of key individuals in the field
  • Brings together emerging analytical and inhalation technologies
Anthony J. Hickey, PhD, DSc, currently serves as a distinguished fellow and senior research pharmacologist at RTI International. He has more than 30 years of academic and research experience in the areas of pulmonary biology, aerosol physics, powder dynamics, pharmacokinetics and drug disposition, formulation design, and device develop...
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Title:Inhaled Pharmaceutical Product Development PerspectivesFormat:PaperbackDimensions:150 pages, 8.75 × 6.35 × 0.68 inPublished:September 1, 2017Publisher:Elsevier ScienceLanguage:English

The following ISBNs are associated with this title:

ISBN - 10:0128122099

ISBN - 13:9780128122099

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Table of Contents

1. Introduction-Historical Perspective
Inhaled Products
Scientific Advances
Technical Advances
Regulatory Advances
Conclusion
References
2. Dosage Forms
Metered Dose Inhalers
Dry Powder Inhalers
Nebulizers
Other Products
Specialized Formulations
Manufacturing
Performance Criteria
Conclusion
References
3. Quality and Performance Tests
Physical Tests for Drup And EXcipient Characterization
Aerodynamic Particle Size Distribution
Delivered Dose and Uniformity
Other Factors
IVIVC Considerations
Statistical Parameters
Stability
Conclusion
References
4. Preclinical and Clinical Considerations
Lung Deposition Imaging
Lung Deposition Modeling
Animal Models
Cell Culture
Pharmacokinetics
Pharmacodynamics
Conclusion
References
5. Regulatory Strategy
General Principles
Therapeutic Agents
Conclusion
References
6. General Conclusion
Appendices
Index