Morris J W
G.D. Searle, Skokie, Illinois 60077.
J Biopharm Stat. 1992;2(1):83-90. doi: 10.1080/10543409208835032.
While a large portion of pharmaceutical stability data is known to follow an exponential model decay, linear modeling of this data for expiry estimation is the norm. Expiry predictions based on linear and exponential fits to stability data were made to estimate the bias due to the linear fitting. It was found that within the usual expiry limits on drug potency, the difference between the model fits is relatively trivial. In cases of loss of potency greater than 15%, small assay variability, or great disparity between the length of the study and the time of expiry prediction, however, there is a nontrivial difference in the predictions and the exponential model is preferable.
虽然已知很大一部分药物稳定性数据遵循指数模型衰减，但使用该数据的线性模型来估计有效期是常态。基于对稳定性数据的线性和指数拟合进行有效期预测，以估计线性拟合带来的偏差。结果发现，在药物效力通常的有效期限制范围内，模型拟合之间的差异相对较小。然而，在效力损失大于15%、分析变异性较小或研究时长与有效期预测时间之间存在很大差异的情况下，预测结果存在显著差异，指数模型更为可取。
