stab: An R package for drug stability data analysis

作者：Lee Hsin ya; Wu Pao chu; Lee Yung jin^*

来源：Computer Methods and Programs in Biomedicine, 2010, 100(2): 140-148.

DOI：10.1016/j.cmpb.2010.03.002

• Drug stability
• Shelf life
• ICH Q1E
• ANCOVA
• R

In the pharmaceutical industry, drug stability studies are routinely performed to measure the degradation of an active pharmaceutical ingredient (API) within a drug product. The purpose of drug stability studies is to examine how the API in a drug product varies with time under influence of a variety of environmental factors. The most important study is to establish the expiration date (i.e., the shelf life) of the product. Thus, the aim of this study was to develop an R package to calculate the shelf life based on drug stability data according to the suggested algorithms by ICH Tripartite Guidelines for Q1E Evaluation.

• 出版日期2010-11