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Joachim Ermer (USP)



Advancements and knowledge gaps in ICH Q2(R2)

15 May 2024 | By , , , , , ,

In this article, Amanda Guiraldelli Mahr, Joachim Ermer, Jaime Marach, Phil Borman and other members of USP’s Analytical Procedure Lifecycle Joint Subcommittee explore the latest advancements in ICH Q2(R2) guidelines on validation of analytical procedures and their implications for industry. The authors also identify areas that would benefit from additional guidance and compare…