No. | Strategya | Comments |
---|---|---|
1 | Monitor fewer storage conditions, e.g. only at 30 °C/75%RH to support all filing zones and global labeling requirements | Justification is included in the submission (see Colgan ST (2014); Freed AL. (2016) |
2 | Monitor reduced time points for DS or DP (immediate release, complex modified release) post-approval confirmation and/or annual commitment protocols | |
3 | Employ bracketing or bracketing and matrixing when applicable | |
4 | Monitor only attributes that are stability related quality attributes (SQRAs) or the single shelf life limiting attribute (SLLA) | |
5 | Consider including planned/anticipated post-approval changes (PACs) in the initial Marketing Application (MA) (e.g. in the stability sections of the dossier itself (potential change) or as a post-approval change management protocol) as possible | |
6 | Using ASAP, SRA, statistics, etc. to assess PACs, thereby reducing number of lots, time points, etc. | |
7 | Exclusion of site specific stability information, even for those markets that require site specific stability |