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ICH Q2(R2) provides a framework for validating analytical procedures, and Q14 covers science-based analytical procedure development [11] [13]

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In a statement released earlier this year, Metabolic's parent company Calzada says the obesity program was abandoned in 2007 as trials did not show "a clinically meaningful weight loss outcome across the trial population." Regarding anabolic effects, the company says previous pre-clinical trials "provide clear scientific and medical evidence that AOD9604 does not increase Insulin-like Growth Factor 1." "Furthermore, there is no evidence that AOD-9604 dosing increases the number of muscle or cartilage cells." The company says it is now investigating the drug's potential to repair cartilage, muscle and joint disorders such as osteoarthritis, but only pre-clinical trials have been conducted