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416301116木虫 (正式写手)
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体外酒精突实验设计
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The sponsor should conduct in vitro assessments of the drug release from the drug product using media with various alcohol concentrations on the lowest and highest strengths of the MR drug product. The following points should be considered during the evaluation of the in vitro,alcohol-induced, dose dumping of MR drug products: 申请者应对MR药品（改良药品包括，缓控释片和迟释片）在不同酒精浓度的溶出介质中的释放进行体外评估。即评估MR药品的体外酒精诱导的剂量倾泻实验，过程中应考虑以下几点： Dissolution testing should be conducted using the optimal apparatus and agitation speed. Dissolution data should be generated from twelve dosage units (n=12) at multiple time points to obtain a complete dissolution profile. 溶出度测试应在最佳的装置和搅拌速度进行。溶出度测试应采用十二个剂量单位（n = 12），并设置多个时间点取样，最终以获得完整的溶出度曲线。 The following alcohol concentrations are recommended for the in vitro dissolution studies: 0, 5, 10, 20, and 40 percent. 建议在体外溶出度研究中使用以下酒精浓度：0％，5％，10％，20％和40％。 The general considerations for selecting the media are as follows: 溶出介质选择的注意事项如下： -If the optimal dissolution medium is 0.1N HCl: Dissolution profiles in 0.1 N HCl (pH 1.2) containing the above range of alcohol concentrations are sufficient. -如果最佳溶解介质为0.1N HCl，则在上述酒精浓度范围内的0.1 N HCl（pH 1.2）中测试溶解曲线就足够了。 -If the optimal dissolution medium is not 0.1N HCl: Dissolution profiles using the above range of alcohol concentrations in 0.1N HCl and in the optimal dissolution medium are recommended. -如果最佳溶解介质不是0.1N HCl：建议使用上述浓度的酒精在0.1N HCl和最佳溶解介质中分别测试溶解曲线。 -If the optimal dissolution medium has not been identifie d: Dissolution profiles using the above range of alcohol concentrations in three physiologically relevant pH media (i.e. pH 1.2, 4.5, and 6.8) are recommended. -如果尚未确定最佳的溶出介质，则建议在三种生理相关的pH介质（即pH 1.2、4.5和6.8）中使用上述酒精浓度测试溶出曲线。 -If the dissolution is pH-independent: Dissolution data in 0.1N HCl with the above range of alcohol concentrations are sufficient. 如果溶出度与pH无关：在上述浓度的酒精浓度范围内的0.1N HCl中测试溶解度数据就足够了。 -For a delayed-release (enteric-coated) product: Dissolution data in 0.1N HCl with the above range of alcohol concentrations are sufficient. -对于延迟释放（肠溶衣）产品：在上述浓度的酒精浓度范围内的0.1N HCl中的溶解数据已足够。 The shape of the dissolution profiles should be compared to determine if the modified release characteristics are maintained, especially in the first 2 hours. 应该比较溶出曲线的形状，以确定是否维持改良的释放特性，尤其是在最初的2小时内。 The f2 values assessing the similarity (or lack thereof) between the dissolution profiles should be estimated (using 0 percent alcohol as the reference). 应评估f2值，以评估溶出曲线之间的相似性（或缺乏相似性）（以0％的酒精为参考）。 The report should include complete data (i.e., individual, mean, standard deviation, comparison plots, f2 values, etc.) collected during the evaluation of the in vitro, alcohol- induced, dose-dumping study. 该报告应包括在体外，酒精诱导的剂量倾销研究评估期间收集的完整数据（即单个数据，平均值，标准差，比较图，f2值等）。 Based on the results of the in vitro assessments, an in vivo BA study of the drug product when administered with alcohol may be needed. 根据体外评估的结果，可能需要对药物与酒精一起进行体内BA研究。 Sample Text |
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