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首页> 外文期刊>Journal of pharmaceutical sciences. >A risk-based approach to establish stability testing conditions for tropical countries.
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A risk-based approach to establish stability testing conditions for tropical countries.

机译：为热带国家建立稳定性测试条件的基于风险的方法。

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摘要

The external stability risk factors heat and moisture are evaluated with respect to the development of pharmaceutical products intended to be marketed in tropical and subtropical countries. The mean daily temperatures and dewpoints measured four times per day at selected places in Southeast Asia, South America, China, Southern Africa and the Caribbean are used to calculate the daily and monthly fluctuations of temperature and partial water vapour pressure, the mean kinetic temperature and the relative humidity. Based on these data, the hottest and the most humid place in each country or region are identified to reflect the worst case for the specific region. A formula to calculate safety margins for temperature and partial vapour pressure is introduced taking into consideration the difference between measured meteorological parameters and the stability testing conditions. An appropriate long-term stability testing condition is proposed for each selected country, related to the worst case for each specific region and the safety margins, as well as its classification in either Climatic Zone IVA or IVB.
机译：针对打算在热带和亚热带国家销售的药品的开发，评估了外部稳定性风险因素热量和水分。在东南亚，南美，中国，南非和加勒比海的某些地方，每天四次测得的平均每日温度和露点用于计算温度和部分水蒸气压的每日和每月波动，平均动能和相对湿度。根据这些数据，确定每个国家或地区中最热和最潮湿的地方，以反映特定地区的最坏情况。考虑到测得的气象参数与稳定性测试条件之间的差异，引入了计算温度和部分蒸气压的安全裕度的公式。建议为每个选定国家/地区提供适当的长期稳定性测试条件，该条件与每个特定区域的最坏情况和安全裕度以及在气候区IVA或IVB中的分类有关。

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