Part V: The Summation of Stability and Quality Attributes
In this five-part blog series, Alcami scientific experts, Russell Crothers and Adam Keisker, go “back to the basics” to examine the importance of stability in pharmaceuticals.
The final post in this series examines the summation of stability’s role in the drug formulation process. From molecule discovery through product release to market, quality attributes are carefully analyzed to support product success and protect patients.
In the first step of the drug formulation process, drug discovery or the non-clinical phase, researchers investigate new understandings about a disease and design a product to stop or reverse its effects. Advanced technologies are explored, often to either target drug substances/active pharmaceutical ingredients (APIs) to specific locations within the body or to manipulate genetic material. During this phase, extensive research and development on how the finished product will be formulated also occurs.