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FIGURE 31 The relationship between dose and effect can be separated into pharmacokinetic (dose-concentration) and pharmacodynamic (concentration-effect) components

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Studies suggest that up to 80% of individuals with ASD may show signs of mitochondrial dysfunction , which affects how cells produce energy

Clinical translation requires human CSF pharmacokinetic assays to prove BBB bypass, a rigorous dose-escalation Phase I trial to establish a safe human NOAEL for chronic dosing, and an RCT utilizing precise neurocognitive testing (e.g., MoCA) to confirm that murine transcriptomic shifts yield functional neuroprotection in humans