運(yùn)用量化模型估計(jì)藥品有效期是長期穩(wěn)定實(shí)驗(yàn)的核心及新藥申報(bào)中的重要節(jié)點(diǎn)。通過對比最新《中國藥典（2015版）》中的對應(yīng)規(guī)定（第IV部，9001章）與國際法規(guī)ICH Q1E中的估計(jì)方法，闡明ICH Q1E是符合國內(nèi)法規(guī)的。其次，通過理論分析解釋了國內(nèi)與國際法規(guī)中量化模型所隱含的假設(shè)及局限性。最后，通過蒙特卡洛模擬得出有效期估計(jì)值的經(jīng)驗(yàn)分布，表明取均值為最終有效期估計(jì)值的方法，可能比ICH Q1E中的方法更傾向于低估真實(shí)有效期，從而置制造方于不必要的劣勢。

Shelf-life estimation is the core of stability tests and critical to the final label claim on the package of new drug. Firstly, this paper depicts the methods of ICH Q1E for shelf-life estimation, compares it to the counterpart in the newest version of Chinese Pharmacopeia (Ch. P 2015, IV-9001), and proves its compliance. Secondly, this paper also unfolds the latent assumptions and hinged limitations of the quantitative methods in the guidelines. Finally, the empirical distributions of the shelf-life estimators are obtained via Monte-Carlo simulation to facilitate better understanding of properties of the estimators. It is shown that the approach that takes the average as final shelf-life estimate is likely to further underestimate the true shelf-life comparing to the ICH Q1E approach, and hence puts the manufacturers in unnecessary disadvantage.