Quantitative models for drug shelf-life estimation
10.7501/j.issn.1674-6376.2017.05.011
- VernacularTitle:论药品有效期估计的量化模型
- Author:
Jianxun JI
- Keywords:
shelf-life;
stability test;
quality control;
statistical models;
ICH
- From:
Drug Evaluation Research
2017;40(5):642-647
- CountryChina
- Language:Chinese
-
Abstract:
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.
