Forced degradation studies (FDS) are a crucial part of the drug lifecycle process because companies need to fully understand their molecule, including how it reacts to different stress conditions. However, there is a lack of clear regulatory guidance on how, when and...
Since its start in 2013, the Formulation Point Share has been busy. In February 2018 It published, An inter-company perspective on biopharmaceutical drug product robustness studies, in the Journal of Pharmaceutical Sciences which was viewed online over 1,000 times in...
