Fidelta introduces a generic approach for conducting stress testing on drug substances and drug products.
The established strategy is evaluated and verified according to the regulatory guidance documents (ICH guidelines, FDA Guidance for Industry, FDA Reviewer Guidance, European Pharmacopoeia, etc.), with emphasis on what should be considered during early development as well as for late-clinical phases and for registration application dossiers. Stress testing of the drug substance can help identify the likely degradation products, which examination can be useful in establishing degradation pathways, the intrinsic stability of the molecule and validate the stability-indicating potential of analytical method used.
This results could be helpful by generation of more stable formulations and can be used for development of manufacturing processes or to select proper packaging and conditions for long-term storage.
Forced Degradation Study Design
Stability-stress testing will be performed in different pH environment, in the presence of oxygen and ID65 light and at elevated levels of temperatures and humidity, in a solid form and / or in solution.