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.