White Paper

The Importance Of An Analytical Testing Strategy For Combination Products

As combination products evolve and a preference for self-administration systems such as prefilled syringes, auto-injectors, and pen injectors commercialize, there is a need to ensure proper testing of both the primary and secondary components in compliance with regulatory guidelines. The combination product development process to focus on the user-friendliness, or human factors, of self-administration systems, very often involves new and innovative drug products. One crucial aspect of this process focuses on regulatory submission. A foundational point that tends to be overlooked, and required for regulatory submission, is the analytical testing strategy that supports the combination product development process, whether at the stages of concept, feasibility, development, or product release.

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