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In addition, the transition from laboratory-scale research to clinical application faces substantial barriers, including extensive preclinical testing to establish safety and efficacy, the complexities of large-scale manufacturing to ensure consistent quality, and the rigorous regulatory approval processes that demand considerable time and resources (Oliva et al., 2021

Initially this inherent variability was attributed to differences in the epigenetic silencing of the transgenes which were used to reprogramme the somatic cells 40

Fries, E., Dettenborn, L., and Kirschbaum, C (2009)

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Tight junction defects in patients with atopic dermatitis

The single ascending dose portion of the study was designed to assess the safety and tolerability of AMG 966 at each dose level