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[DOI] [PubMed] [Google Scholar] 62.Glabowski W, Kurzawa R, Wiszniewska B, Baczkowski T, Marchlewicz M, Brelik P

Unlike domestic FDA guidance, ICH E6(R3) carries harmonized weight across FDA, EMA, PMDA, and MHRA-regulated trial submissions, enabling sponsors to design global protocols against a single set of GCP principles rather than navigating jurisdiction-specific interpretations

PPIs are more powerful and common, but H2 blockers can also affect vitamin B12 absorption