Combination Products/Drugs in Devices

The purpose of this chapter is to cover additional considerations, guidelines and requirements to help the reader design stability strategies for drug-device combination products. Tests and challenges to be included in stability studies are considered from a regulatory and scientific point of view and these are also related to the stage of development of the product. A number of drug-device combination types including inhaled/nasal products, pen injectors, drug-eluting stents and transdermal products are discussed specifically.