employed in osteoarthritis and cartilage regeneration research Pigs Used for pharmacokinetic profiling and oral bioavailability studies Cynomolgus monkeys 9-month chronic toxicology studies via oral gavage Human subjects Approximately 900 participants across six clinical trials examining safety and efficacy Research Limitations & Regulatory Status Critical Gaps in Current Evidence Despite over 25 years of research and extensive clinical testing, AOD-9604 faces substantial evidence gaps that have prevented therapeutic development
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This is particularly relevant for oral administration, which is subject to intrinsic factor saturation and receptor limitations in the ileum (Paul and Brady, 2017
Data that remained non-normally distributed and/or heteroscedastic after log transformation were analyzed (not log-transformed, but still 1e13-transformed) with a KruskalWallis test, while normally distributed and homoscedastic data were analyzed with a one-way ANOVA, performed on the log-transformed data as necessary