What Does PAT Mean for Inhalation Products
Golden MH.
Respiratory Drug Delivery 2006. Volume 1, 2006: 143-150.
Abstract:
The approach to development and registration for inhalation products is evolving as a result of recent FDA and ICH initiatives and guidances. In particular, the PAT guidance provides a framework for developing and regulating drug products that should lead to the application of innovating manufacturing systems, improved product quality, and reduced regulatory burden. The draft ICH Q8 guidance describes how the knowledge gained during product development should be communicated in the NDA. Recent organizational and regulatory review process redesign at FDA suggests that “Quality by Design” concepts are being transformed from theoretical concepts to reality. This paper describes the impact of these changes on the product development process for inhalation products, as well as implications and uncertainties in the new regulatory review process.
Access to this article is complimentary.
RDD Articles are provided in PDF file format. 
Access to RDD Articles is subject to our Terms of Use Agreement [PDF].
