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The applicant must demonstrate that the proposed product is the same as the reference product in active ingredient, dosage form, strength, route of administration, and labeling, and that it is bioequivalent

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These synthesis-dependent choices directly influence drug loading capacity, pH-responsive release, organelle targeting, and cellular uptake, highlighting that therapeutic efficacy arises from deliberate surface and structural engineering, rather than from the carbon core alone

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Probabilistic sensitivity analysis with sampling around cohort characteristics, treatment effects, complication costs and utilities yielded similar mean results to the base case analyses, but with increased measures of variance around outcomes