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 perspectiveDiscusses development strategies and best practices to support regulatory submissionsWritten by an experienced expert and draws on the knowledge and critical opinions of key individuals in the fieldBrings together emerging analytical and inhalation technologies INDICE: 1. Historical Perspective: Research, Development, Regulatory2. Dosage Forms3. Quality and Performance Tests4. Regulatory Strategy5. Conclusions
- ISBN: 978-0-12-812209-9
- Editorial: Elsevier
- Encuadernacion: Rústica
- Páginas: 150
- Fecha Publicación: 01/09/2017
- Nº Volúmenes: 1
- Idioma: Inglés