Год выпуска: 2013 Автор: Virendra Dhakar and Bheru Malviya Издательство: LAP Lambert Academic Publishing Страниц: 112 ISBN: 9783659456008
Описание
Stress testing (or forced degradation studies) is an important part of the drug development process and the pharmaceutical industries have considerable interest in this area. Although the concept of stress testing is not new to the pharmaceutical industry, the procedure was not clearly defined until the International Conference on Harmonization (ICH) which provided a definition in its guidance on stability. The ICH guideline indicates that stress testing is designed to help “To determine the intrinsic stability of the molecule by establishing degradation pathways in order to identify the likely degradation products and to validate the stability indicating power of the analytical procedures used.”
