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Regulatory success depends not only on clinical performance but on a comprehensive analytical package that establishes structural and functional equivalence

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Compounded medications are not FDA-approved, and a licensed provider must decide whether treatment is appropriate

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In BECs, PICALM guides A trafficking to Rab5-positive early endosomes and Rab11 that leads to A transcytosis rather than Rab7, a GTPase that directs to lysosomes leading to degradation of ligands (Zhao et al., 2015b)

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