Advancements and knowledge gaps in ICH Q2(R2)

Starting with the relationship between ICH Q14 and Q2(R2), the authors take a critical look at the new aspects incorporated in ICH Q2(R2). The concepts of selectivity and specificity, range and response, as well as accuracy and precision are discussed in more detail. The authors also identify areas needing additional guidance and compare how the latest ICH Q14/Q2(R2) guidelines align with US pharmacopeial approaches.

The authors conclude that "the revised ICH Q2(R2) guideline updates terminology and broadens the scope of techniques/products applicable, improving validation requirements for uni- and multivariate analytical procedures, while maintaining traditional approaches." It also says that "while both Q14 and Q2(R2) align with principles outlined in USP <1220>, further clarity and alignment between the two guidelines are needed to promote a comprehensive lifecycle approach."

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