Additional Studies Requested by the FDA - PharmaCyte has designed and commenced various additional studies requested by the FDA, including a stability study on the cells from its Master Cell Bank (MCB ...

Forced degradation studies involve exposing a drug substance to harsher conditions than the product would be expected to experience and determining at what point and how it degrades. Identifying ...

Before taking our survey, 16% of respondents were not aware of the CMS regulation and interpretive guidelines that require pharmacists to store drugs and biologicals in accordance with the ...

Develop and maintain institutional policies for preclinical investigational product development Provide quality management assurance that preclinical product development processes, activities, and the ...