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Hepatic steatosis results largely from enhanced lipogenesis coupled with reduced fatty acid oxidation

Available from: Balogun, J.A

Key takeaways from this document include the need for stress testing to identify degradation pathways, using at least three pilot-scale batches to establish re-test periods or shelf lives, and adhering to specific storage conditionssuch as 25C 2C/60% RH or 30C 2C/65% RH for long-term studies