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Updated: Jun 30, 2026

An In Vitro Skin Irritation Test SIT using the EpiDerm Reconstructed Human Epidermal RHE Model
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在体外口腔刺激试验中的敏感性分析和质量指标

Robert Gutierrez1, Blaza Toman2, Yong Ma2

  • 1Biosystems and Biomaterials Division, Material Measurement Laboratory, National Institute of Standards and Technology (NIST), Gaithersburg, MD, USA.

ALTEX
|August 12, 2024
PubMed
概括

对牙科材料进行预测性体外生物相容性测试至关重要. 这项研究优化了使用3DEpiOral构造和MTT试验的口腔刺激试验,提高了新牙科材料开发的可靠性.

关键词:
3D构造的3D构造牙科材料 牙科材料方法验证方法的验证方法.新方法的方法新方法的方法.技术质量 技术质量

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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 adhering...