Development and validation of analytical methods indicator of stability for the control of active pharmaceutical ingredients (APIs) and drug products (DP).
Set up of stability studies protocols according to the international guidelines (ICH).
Forced degradation studies of APIs, isolation, characterisation, and synthesis of degradation products.
Impurity profiling (LC-UV-HRMS).
Physicochemical characterisation of new chemical entities: e.g. solubility (Shake flask and Multiscreen), Log P
Metabolic stability in different matrices and species (microsomes, S9, plasma)
In vitro metabolite profiling by HRMS and phenotyping
Bioanalytical methods development and validation for in vivo DMPK
