In-Use Studies

Injectable medicines have several advantages, including rapid absorption and onset of action, compared to oral drugs, but they also present unique safety challenges for patients. Injectables are capable of bypassing natural skin and digestive tract barriers designed for toxins, and because of this ease of administration, all injectable medicines must face additional regulatory requirements. Specifically, injectables requiring multiple doses are subject to the most stringent regulatory control, and for these cases, regulations mandate that in-use testing be performed on multiple-dose containers.

In-use studies are intended to demonstrate that multi-dose injectable drug products retain acceptable quality specifications upon opening or puncturing of the container and throughout the drug’s administration into a human patient. If applicable, an assay of the API and preservative should be performed throughout the duration of the in-use study to monitor the levels at each testing interval. Additionally, Antimicrobial Effectiveness Testing (AET) per USP <51>, or Sterility Testing per USP <71> as an alternative, should be performed at the end of the study.

At Cambrex, we will work with you to design and perform all in-use testing and microbiological safety testing for your final marketed drug product and associated container/closure system. Our experts can design and perform all of the testing needed for in-use studies by leveraging our analytical expertise and demonstrated excellence in microbiological safety testing. We are here to help you clear the regulatory hurdles and advance your injectable product to the market.