Inhaled Pharmaceutical Product Development Perspectives: Challenges and Opportunities

ISBN-13: 9780128122099 / Angielski / Miękka / 2017 / 110 str.

Anthony J. Hickey

Opis

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
• Brings together emerging analytical and inhalation technologies

Spis treści

1. Introduction-Historical Perspective2. Dosage Forms3. Quality and Performance Tests4. Preclinical and Clinical Considerations5. Regulatory Strategy6. General Conclusion

O autorze

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 development. His research has focused on improving understanding of the physiology, pharmacology, and immunology of the lungs. Throughout his career, Dr. Hickey has worked on intranasal and inhaled vaccine development and drug delivery for diseases affecting the respiratory tract, including asthma, chronic obstructive lung disease, tuberculosis, and cystic fibrosis. He has also studied the performance of powders and particles in drug and vaccine delivery systems. He received his PhD and DSc degrees in pharmaceutical sciences from the University of Aston in Birmingham, a master's degree in toxicology from the University of Birmingham, and a bachelor's degree in biology from Portsmouth Polytechnic.