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10.1016/j.tins.2009.08.002 Trends Neurosci

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The legitimate path to combination therapy is through formal drug development: Companies design specific combinations based on mechanism rationale Pharmacokinetic studies characterize how the drugs interact Phase 1 establishes safety in healthy volunteers Phase 2 finds optimal doses for combinations Phase 3 demonstrates efficacy and safety vs comparators FDA approval enables labeled use Patient-led ad-hoc combinations skip all of these steps