Who is the specification aimed at?
The specification is aimed at anyone considering designing or commissioning the design of a dry powder inhaler as a check list of essential design inputs. It is also aimed at those upgrading or improving existing devices as it provides an up-to-date description of current guidelines. Although the specification is aimed at devices that would be marketed in the US or Europe, it has also previously been applied to devices aimed at the Asian market. As is the likely case with any specification designed by a single commercial company, the specification has not been approved by regulatory bodies, but it has been used for the development of a number of DPI devices undergoing clinical trials. Q2: How does Cambridge Consultants’ second generation DPI generic specification aid DPI development? It defines the scope of the design and engineering inputs, which form the basis of successful product development. By offering a route map to compliance with regulatory and safety requirements, , the speci
