Книга: Virendra Dhakar and Bheru Malviya «Forced Degradation Behavior of Etizolam»

Производитель: "LAP Lambert Academic Publishing"

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. ISBN:9783659456008

Издательство: "LAP Lambert Academic Publishing" (2013)

ISBN: 9783659456008