稳定性数据评价（Stability data evaluation）.docVIP

稳定性数据评价（Stability data evaluation） The document comes from the network, it is my own collection organized, if have omitted, the error, still asks everyone to correct! Stability data evaluation 1. Introduction 1.1 purpose of the guide The purpose of this guide is to provide how to use according to ICH guideline Q1A (R) in detail the principle of stability test the new drug substances and drug products (hereafter referred to as the general guiding principles) and the stability data is introduced to suggest to trial or shelf life The guidelines describe when and how to use the limited extrapolation to recommend the retesting period of the API or the shelf life of the API that exceeds the range of observations of data from long-term storage conditions 1.2 background The guidelines on the evaluation and statistical analysis of stability data provided by the general guidelines are brief and limited in nature Although total guiding principle is pointed out that the method of regression analysis is acceptable to the analysis on trial or shelf life evaluation of quantitative stability data, and suggested to use 0.25 significance level operation combined group of statistical tests, it rarely include details In addition, the general guiding principle does not include when compound factors are included in the overall or reduced - design survey The evaluation portion of the general guidelines will be repeated, and therefore deleted, as the fourth step of the guideline 1.3 scope of guidance The guidelines, the total guiding principle of attachment, purpose is to be based on the quantitative and qualitative evaluation and the stability of the nature of the test data suggest to trial or shelf life and storage conditions provide the expected value of a clear explanation This guide Outlines the stability data based on single or compound factors and overall or equivalent - design surveys to determine the retest period or shelf life ICH Q6A and Q6B provide guidelines for adjusting and