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Pre-Clinical: tests the drug on non-human subjects for efficacy, toxicity, and pharmacokinetic information.

Phase 1: first time the drug is tested in humans for assessment of the safety of the drug.

Phase 2: Assesses the drug’s safety and efficacy and also optimal dose strength analysis.

Phase 3: Larger scale human trials for confirmation of phase 2 efficacy and safety results. 

 Shackelford Pharma is able to bypass Phase 1 testing because the active pharmaceutical ingredient(s) of the formulation(s) have been tested and approved previously by the FDA. 

AAMI = Age Associated Memory Impairment

A,B,C = Undisclosed Epileptic Conditions

TBD = To Be Decided

NCE = New Chemical Entity


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