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运用量化模型估计药品有效期是长期稳定实验的核心及新药申报中的重要节点。通过对比最新《中国药典(2015版)》中的对应规定(第IV部,9001章)与国际法规ICH Q1E中的估计方法,阐明ICH Q1E是符合国内法规的。其次,通过理论分析解释了国内与国际法规中量化模型所隐含的假设及局限性。最后,通过蒙特卡洛模拟得出有效期估计值的经验分布,表明取均值为最终有效期估计值的方法,可能比ICH Q1E中的方法更倾向于低估真实有效期,从而置制造方于不必要的劣势。
The use of quantitative models to estimate drug expiration dates is the core of a long-term, stable experiment and an important node in new drug reporting. By comparing the latest Chinese Pharmacopoeia (2015 edition) of the corresponding provisions (Part IV, Chapter 9001) and international regulations ICH Q1E in the estimation method to clarify that ICH Q1E is in line with national laws and regulations. Secondly, the theoretical analysis explains the assumptions and limitations implied by the quantitative models in domestic and international regulations. Finally, empirical distributions of the validity estimates using Monte Carlo simulations show that taking the mean as a measure of the final validity may be more likely than the ICH Q1E to underestimate the true validity, placing the producer at an unnecessary disadvantage .