A statistical procedure based on a quality range is proposed for demonstrating comparability between pre-change and post-change process slopes in an accelerated or stressed stability study. To assess ...

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 ...

Maintaining the required solubility, stability, efficacy and potency of an engineered biotherapeutic protein is critical after its expression in a recombinant system. Analysis and optimization of the ...

Stability studies measure how medical devices respond to environmental stresses such as temperature, humidity, light, and ...