博文

目前显示的是 二月, 2022的博文

Drug Stability Testing and Analytics

  Consumers may take it for granted that a therapeutic drug product in the household medicine cabinet effectively does what its label claims( medicine stability chamber ). Likewise, medical professionals expect prescribed products to comply with efficacy, safety and stability requirements. The confidence of both parties is based on the expectation that biopharmaceutical companies thoroughly test therapeutic products long before they reach the market. Considering stability, biopharmaceutical manufacturers need to know that as a product sits on a shelf, it won’t lose its effectiveness or degrade into something dangerous to consume. For finished product stability testing, a product is stored in controlled conditions and then periodically removed from those conditions and examined to ensure it adheres to standards. Various characteristics are measured to create a degradation line over the shelf life of a product. In some cases, a study may span many years. For a substance in developmen