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The management of PFO in patients over 60 years and CIS remains to be clarified

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The Regulatory Landscape: What You Should Know The FDA's position on peptides has evolved

In compliance with the relevant FDA and EMA guidelines [911], for each of the two test liquid formulations, bioequivalence was concluded if the 95% CIs for the estimated test/reference ratios of geometric means of AUC 0-t and C max were within the standard pre-specified acceptance range for bioequivalence (0.80-1.25)