Preformulation Late Stage Development Support

After a new chemical entity has been selected to move forward to development, the preformulation scientist supports the studies related to formulation, 

Based on the previous knowledge about the properties of novel chemical entity obtained during the late discovery and nomination, the stability studies of API are performed based on ICH guidance [43]. 

Since the degradation products are not yet identified in this stage, it is advisable to use detection systems, which have universal response and also provide high sensitivity. MS is probably the most sensitive detector that also 

The key to a good stability-indicating assay is to select concentrations for analysis that allow the detection of degradation product peaks that are at least 0.1% of the parent peak, which is consistent with ICH impurities guideline [54]. 

TABLE 12-7. Example of Drug-Excipient Compatibility Testing Design. Reprinted with Permission from reference 59. 

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