ABSTRACT
As more drug and device manufacturers are developing combination products, new and complex interactions among drug constituent parts, medical device constituent parts and related components have arisen. Although a combination product may be comprised of an already approved drug and an already approved device, new scientific and technical issues may arise when the drug and device are combined for use together. It is critical to understand the compatibility and performance of both the drug constituent part and the device constituent part, and of the drug - device combined use as a system, in order to ensure successful development of the combination product. This chapter reviews developing and applying a strategy for component and system qualification to ensure drug-, and medical device- constituent part quality, safety and efficacy. Beyond constituent parts, manufacturers also need to understand how chemical, physical and functional aspects of drug and device all come together to function safely and effectively as a combination product system. This chapter introduces the types of analytical testing generally required for companies entering into the combination product development space. Included is a roadmap of the types of testing required, with an emphasis on the fact that where historically testing might have been thought of as drug OR device testing, now it needs to take into account the other constituent part and potential interactions between the two. Discussion includes best practices, techniques and approaches for: compendia, biocompatibility, extractables and leachables, container-closure integrity, potential particle generation, functional performance and stability. Examples of combination product-specific considerations are highlighted throughout the chapter.
