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In some instances, upon administration of a controlled release auris formulation or composition described herein (e.g., a formulation comprising a therapeutic agent), drug concentrations relative to the binding constants of one or more otic receptors are relevant in determining a biologically meaningful PK profile or the minimum concentration of an active agent required for a therapeutic effect
Four release-panel assays (HPLC purity, LC-MS identity, C-terminal amidation verification, LAL endotoxin) run against pre-locked numerical criteria, and the lot stays in held status until all four pass
The rate of breakdown (or duration of result) is greatly affected in Juvederm specifically by the amount of movement in the area where it is placed
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