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长效甲基酸盐的药理动力学:配方差异,生物等价性,可互换性
Mostafa Moharram1, Tony Kiang2
1Faculty of Pharmacy and Pharmaceutical Sciences, University of Alberta, 3-142D (Office), 3081 (Lab) Katz Group Centre for Research, 11315, 87 Ave NW, Edmonton, AB, T6G 2H5, Canada.
延长释放甲基化物 (MPH) 配方在监管指南中显示出不一致的生物等价性. 需要进行进一步的研究,以确定生物等价性是否足够确保MPH可用于ADHD治疗的可互换性.
科学领域:
- 药理动力学和药物配方 药理动力学
- 神经精神疾病 神经精神疾病
- 监管科学 监管科学
背景情况:
- 注意缺陷多动症 (ADHD) 是一个常见的儿童神经精神疾病.
- 甲基 (MPH) 是一线ADHD治疗,可用于各种延长释放 (ER) 配方.
- 药理动力学的差异往往导致ER MPH配方不被认为是生物等价的.
研究的目的:
- 批判性地审查ER MPH配方的药理动力学数据.
- 评估生物等价性并确定监管指南中的不一致性.
- 评估药理动力学-药理动力学参数,以确定MPH的可互换性.
主要方法:
- 在EMBASE,Medline和Cochrane图书馆进行了全面的文献搜索.
- 提取了研究特征,药理动力学参数和生物等价性数据.
- 分析了ER MPH配方的直接和间接比较研究.
主要成果:
- 33项研究提供了ER MPH的初级药理动力学数据.
- 监管机构一贯报告两种配方是生物等效的,但注意到了不一致性.
- 更严格的生物等价性标准显示,只有一种配方符合定义;临床因素有不一致的影响.
结论:
- 改进的药理动力学参数和标准化的监管准则可以改善ER MPH的生物等价性评估.
- 需要进一步的研究来确定生物等价性是否是MPH可互换性的最佳衡量标准.
- 这些发现与配方科学家,临床药理学家和参与ADHD治疗的临床医生有关.
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