Inhaled Pharmaceutical Product Development Perspectives

Paperback | September 1, 2017

byAnthony J. Hickey

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Inhaled Pharmaceutical Product Development Perspectives describes 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

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Inhaled Pharmaceutical Product Development Perspectives describes 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 r...

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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Format: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. Historical Perspective: Research, Development, Regulatory
2. Dosage Forms
3. Quality and Performance Tests
4. Regulatory Strategy
5. Conclusions