5 Common Questions Related To Stability And Storage
One of the most crucial and vital aspects of biopharmaceutical development and manufacturing is Drug Stability. Millions of dollars and a whole lot is put on the line for the company involved with even the smallest mishaps. Owing to the importance of this critical facet, Stability Studies are conducted during various stages of development to ensure that the drug remains safe and potent after it exits the manufacturing facility. Listed below are a few common tests along with a brief explanation. 1. Real-time Stability Test Conditions Real-time stability tests are considered the best way to determine the shelf life of the drug. They often span for a time period of about two years. Pharmaceutical companies perform these tests at room temperature, under natural light and an expected level of humidity. These tests are performed periodically until the drug fails. 2. Accelerated Stability Test Condition In this type of stability study , the drugs are subject to stress...