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Nature does it better: mimicking in vivo conditions to resolve in vitro production side effects

Enrico Dalle Palle1, Koray Tekin2, Calogero Stelletta1

  • 1Department of Animal Medicine, Production and Health, University of Padua, Legnaro, Italy.

Frontiers in Veterinary Science
|October 13, 2025
PubMed

Keywords:
3D cell cultureembryosextracellular vesiclesin vitro production IVPlarge offspring syndromeoviductal fluid

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In pharmaceutical development, it's crucial to establish a predictive in vitro–in vivo correlation (IVIVC) for two or more formulations to gain a comprehensive understanding of release properties. IVIVC reduces the need for costly in vivo studies and facilitates the establishment of meaningful dissolution specifications with significant cost savings and decreased regulatory burden. Furthermore, a meaningful IVIVC should predict Cmax and AUC within 20%, aligning with FDA guidance while...
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