Early Completion of Model-Assisted Designs for Dose-Finding Trials Accurate assessment of a molecular classifier that guides patient care is of paramount importance in precision oncology. Recent years ...

In this study, a direct HPLC method was developed to determine the enantiomeric purity of the immunomodulatory drug, ozanimod. A systematic method development process was followed, incorporating risk ...

In pharmaceutical manufacturing, cleaning validation is an essential stage of verifying that the manufacturing process is suitable. As an integral stage of the cleaning validation program, analytical ...

Laboratory-based design verification testing (DVT) of combination products and medical devices must be performed to demonstrate that the device meets the performance requirements that were set in the ...

In the information age, bridging the gap between data and clinical application is crucial. The Center for Clinical and Translational Science (CCTS) is making significant investments in this area. Over ...