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温度外观管理:一种基于商业口服固体剂型的层级方法

Shalini Raj Unnikandam Veettil1, Gianna Respicio1, DeeDee Zhang1

  • 1Gilead Sciences Inc., Foster City, California, 94404, USA.

The AAPS journal
|October 1, 2024
PubMed
概括

温度偏差可以影响药物的质量. 本研究提出了一种分层方法来评估温度外流对小分子药物的影响,确保产品的安全性和可用性.

关键词:
在Arrhenius方程中,货架寿命限制 时间限制固体口服剂量固体口服剂量稳定的稳定性 稳定的稳定性温度外流管理的温度外流管理.

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