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The European Association for the Study of the Liver (EASL) clinical practice guidelines on Wilson disease note that hepatic copper exceeding 250 mcg/g dry weight is a strong diagnostic criterion for Wilson disease, but subclinical copper accumulation can begin at much lower thresholds in patients with cholestatic or cirrhotic liver disease [2]

Therefore, assessing the true effect of a disease-modifying therapy early on is critical, even in the presence of symptomatic medications

Several compounding pharmacies filed a lawsuit arguing the FDA had skipped legally required steps

Clinical Implementation Challenges Patient Selection and Individualization The importance of individualized dosing and patient assessment to optimize safety and efficacy [68] [69] [70] represents a key implementation challenge