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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…mehr

Produktbeschreibung
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."
Autorenporträt
Virendra Dhakar is presently Pharmacist in NRHM formerly Assistant Professor in Shri RNS Institute of Pharmaceutical science and technology Gwalior .He has also credit to author of two books namely "Textbook of Pharmaceutical Packaging Technology" & "Forensic Pharmacy" and three Research Paper that are Published in international Journals