stab: an R package for drug stability data analysis.
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.
Lee
Hsin-ya
HY
Faculty of Pharmacy, Kaohsiung Medical University, No. 100, Shih-chuan 1st Rd., Sanmin District, Kaohsiung City 807, Taiwan. u9583002@kmu.edu.tw
Wu
Pao-chu
PC
Lee
Yung-jin
YJ
D000465:Algorithms; D003663:Decision Trees; D004345:Drug Industry; D004355:Drug Stability