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Proving the exogenous origin of peptidic drugs and respective analogs at lowest concentration levels in biological specimens (commonly blood, serum and urine) of rather limited volume is required to pursue an action against ch View Full Study Analytical approaches for the detection of emerging therapeutics and non-approved drugs in human doping controls

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AOD-9604 FDA Approval History At a glance FDA approval status / Never approved for any indication in the United States NDA filing history / No New Drug Application has ever been submitted to FDA Chemical identity / Synthetic peptide corresponding to amino acids 176-191 of human growth hormone, with a tyrosine residue added at the C-terminus Developer / Metabolic Pharmaceuticals Ltd (Melbourne, Australia), now defunct Clinical trial outcome / Phase IIb trial (2007) failed to meet primary efficacy endpoint for obesity FDA compounding status / Placed on Category 2 list

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