Review of in-use stability: current practices, emerging requirements, expectations, challenges and trends

Abstract In-use stability studies are critical to define handling instructions based on storage conditions, hold-time and compatibility of administration components for inclusion in the product label and pharmacy manual. In-use studies evaluate product quality from dose preparation to administration, including dilution for infusion or compatibility with administration systems like IV bags, syringes, and tubing. Given the limited number of published regulatory guidances, defining consistent approaches can be challenging leading to diverse global practices across the industry. The AAPS Stability Community led several discussions including a virtual roundtable event to examine industry practices on key considerations when designing an in-use study including current approaches based on feedback from regulatory agencies. In addition, a thorough review of several related symposiums and seminars was conducted to assess this area and current industry practices. This paper streamlines approaches, facilitates interactions with regulators, and enables ongoing development efforts for product quality and performance.