Maximizing and validating the stability of a drug is critical throughout its life cycle, beginning in the development phase of an active pharmaceutical ingredient (API), continuing through the final ...

Although stability testing programs for small-molecule drugs and biologics are often perceived as similar, stability programs for biologics are far more complex. The purpose of stability testing ...

Stability testing is essential in the pharmaceutical and biopharmaceutical industries. These tests are performed to evaluate the stability of drug products under various environmental conditions. Once ...

Biologics stability testing in pharmaceutical R&D typically requires weeks of waiting between processes. Formulation scientists must develop, assess, and then wait to discover if a formulation remains ...

Table 1. Factors to consider in real-time stability study (click to enlarge). Figure 1. Effect of material change on stability profile (click to enlarge). Figure 2. Correleation of stability failure ...

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