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(2) Variability-driven regulatory failure: Coefficients of variation exceeding 50%60% preclude bioequivalence demonstration for dose-critical molecules whose therapeutic effects depend on achieving specific concentrations at specific times

The body therefore needs carnitine in order to function properly, particularly the muscles which need a constant supply of "fuel." The human body synthesizes the carnitine it needs from lysine and methionine, two amino acids found in food