Being the first to market with a generic drug can result in capturing as much as 90% of the market share for the initial three years, making it imperative for manufacturers to address risks early in the drug development process. Explore the untapped potential for injectable generic drug growth and three priorities for maximizing speed to market.
Selection of the appropriate primary packaging system is essential to delivering a high quality, safe, and stable drug product. Mapping risks to CCI early in development, alongside selecting components demonstrated to mating together well, inevitably help affordable medicine manufacturers mitigate risk and delays.
This report discusses results of two, two-year studies that indicate, for a properly-assembled vial containment system, good container closure integrity performance can be achieved with stoppers of a given elastomer, independent of configuration.
Complex drug product formulations have become more common, so it is imperative to have a deeper knowledge of extractables to understand risks associated with potential interactions between packaging and drug product. How can you begin to manage these risks?
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.
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