Combination Products/Drugs in Devices

  • Jon V. Beaman
  • Roisin Wallace


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.


Combination Product European Medicine Evaluation Agency Product Quality Research Institute Medical Device Directive Deliver Dose Uniformity 
These keywords were added by machine and not by the authors. This process is experimental and the keywords may be updated as the learning algorithm improves.


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Copyright information

© Springer Science+Business Media, LLC 2009

Authors and Affiliations

  1. 1.Pfizer Global Research and DevelopmentSandwichUK
  2. 2.Analytical Science (Chemistry) at Dublin City UniversityDublinIreland

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