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The limits of detection (LOD) and quantitation (LOQ) were established using drug-free matrix spiked with known concentrations of DOX (with IS), and the lowest concentration in the calibration curve was required to yield a signal-to-noise (S/N) ratio of 3 and 10, respectively

Both options include provider supervision, 503A compounded medication from a licensed pharmacy, dosing instructions, and follow-up

If after a reasonable period of time, there is a lack of satisfactory clinical response, Prednisolone Sodium Phosphate Oral Solution (10 mg Prednisolone per 5 mL), Prednisolone Sodium Phosphate Oral Solution (15 mg Prednisolone per 5 mL), Prednisolone Sodium Phosphate Oral Solution (20 mg Prednisolone per 5 mL) and Prednisolone Sodium Phosphate Oral Solution (25 mg Prednisolone per 5 mL) should be discontinued and the patient placed on other appropriate therapy

Section 1860D-14B(b)(1)(B) of the Act requires that beginning with the plan year 2026, we must exclude from the total number of units for a Part D rebatable drug, for an applicable period, those units for which a manufacturer provided a discount under the 340B Program