Long-term stability testing is an essential aspect of the development and commercialization of nanomedicines and nanoparticle-based drug products. It helps ensure that these formulations maintain their quality, efficacy, and safety throughout their intended shelf life. Here are some key considerations and parameters to assess during long-term stability testing:
3. Sterility and Microbial Contamination:
Stability testing should be performed at different time points during the development process and periodically throughout the product's shelf life. The duration of long-term stability testing depends on the intended shelf life of the product and regulatory requirements. The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) provides guidelines (e.g., ICH Q1A(R2)) that outline stability testing protocols for pharmaceutical products, including nanomedicines and nanoparticle-based drug products.