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This requires comprehensive comparability studies against the reference listed drug (RLD), encompassing physicochemical, structural, and biological attributes

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Given the complexity of mitochondrial dysfunction, future strategies may emphasize adjunctive combination therapiesa personalized mito-cocktail combining NAD+ precursors to boost biogenesis, mitochondria-targeted antioxidants to reduce stress, and metabolic modulators to optimize fuel utilization, all tailored to individual mitochondrial phenotype

Baseline serum B12, folate, homocysteine, methylmalonic acid, and liver function tests (ALT, AST) inform starting status and response potential

Concluding remarks Numerous animal studies demonstrate IGF-I as a powerful growth factor for muscle repair