A comprehensive and up-to-date knowledge of stability testing for quality control and quality assurance of pharmaceutical products; different regulations and guidelines regarding stability testing adopted by FDA, WHO and International Conference on Harmonisation (ICH); new approaches to stability testing including "Accelerated Stability Assessment Program" (ASAP) and QbD; chemical stability, physical stability and photo stability, advantages and limitations of accelerated stability testing and routes of accelerated degradation. (2 Credit hours)
