As we all know, accelerated stability testing including test, test and sample tests for a long time. Effect factors test of purpose is clear drug may of degradation way, and preliminary determine drug of packaging, and storage conditions and accelerated test of conditions, while validation prescription of rationality and analysis method of feasibility; accelerated test of purpose is clear drug in deviated from normal storage conditions Xia of degradation situation, and determine long-term left sample test of conditions; long-term stability test of purpose is confirmed effect factors test and accelerated test of results, clear drug stability of changes situation, determine drug of validity ; Long-term test is the core of stability testing for samples.
But, drug development is a systems engineering, from research, and development to production listed, to experience many a stage, including based research, and model of established and development, and clinical Qian research, and clinical test, and registered approval and production listed, stage, pharmacy research is to experience by small try, and in the try to big production step by step zoom of process, how awareness different development stage different scale samples for stability test of purpose and meaning, and different scale samples stability test results on determine or projections products validity of value, Is our drug developers and evaluators should consider problems. In addition, the stability index includes appearance, physical and chemical properties, chemical and microbiological properties, and so on, then these index changes to what is still considered to be stable, this limit is to identify drugs period of validity of the key. Below for the purpose of stability testing on samples of different sizes and significance of how to judge the appearance of drugs, physical and chemical properties, chemical and microbial properties changes; how to determine or calculate the validity of the drug and when determining the validity of the drug problems, talk about their views, share and discuss with the industry.