The development of drug delivery devices that are innovative, intuitive, and patient safe must address certain areas of concern that are particular to both biologic and biosimilar therapies. Understand the need for discreet, frictionless, and user-friendly systems that improve adherence and simplify the delivery process.
Drug-device combination products (DDCPs) leverage new technologies that provide advantages for patients, such as self-administration conveniences and safety, and, for payers, improved adherence. Examine how to establish a holistic approach to DDCP development and how to manage risk throughout the development and approval process.
Waiting until the end of Phase 3 to start planning an E/L testing program can lead to increased costs and delays, stemming from poor assessments that are questioned by the reviewer or incomplete submissions that require the drug company to redo or execute additional work. Learn what you need to know about planning to mitigate delays.
The USP requirements for elastomeric components of container closure systems used for parenteral products are changing. The scope of USP <382> introduces a shift to a holistic evaluation of components when assembled into drug product packaging and delivery systems. Explore the implications for vial, syringe, and cartridge container closure systems.
Discover how choosing the appropriate quality of containment systems from the outset is critical to the successful industrialization of an injectable drug product, and review some of the associated challenges — most notably extractables, leachables, and particulates — that are some of the primary reasons for a product recall.
