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 ...

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 ...

Producing cGMP biopharmaceutical products requires controlled, consistent performance of the manufacturing process. cGMP also requires controlled, consistent performance of analytical test methods.

As drug development becomes more complex, so do the demands for accurate, reproducible bioanalytical data to prove their safety and efficacy. Method validation ensures the reliability of ...

SAN ANTONIO--(BUSINESS WIRE)--bioAffinity Technologies, a privately held biotech company advancing cutting-edge cancer diagnostics, and Precision Pathology Services, a CAP/CLIA-certified anatomic and ...