Description
Inhaled Pharmaceutical Product Development Perspectives: Challenges and Opportunities describes methods and procedures for consideration when developing inhaled pharmaceuticals, while commenting on product development strategies and their suitability to support regulatory submission. It bridges the gap between the aspirations of scientists invested in new technology development and the requirements that must be met for any new product.The book brings together emerging analytical and inhalation technologies, providing perspectives that illuminate 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.- Discusses development strategies and best practices in the context of regulatory requirements- Written by a broadly qualified expert drawing on the knowledge and critical opinions of key individuals in the field- Includes a foreword by Charles G. Thiel
Table of Contents
1. Introduction–Historical Perspective2. Dosage Forms3. Quality and Performance Tests4. Preclinical and Clinical Considerations5. Regulatory Strategy6. General Conclusion
