Bioanalytical method development and validation are at the forefront of ensuring rigorous, reproducible and reliable data in both drug development and clinical diagnostics. The field encompasses the ...

Computerized systems are those which comprise the components shown in Figure 1.1, namely, a computer system and a controlled function which is operating within its specified working environment. The ...

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 ...

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 ...

These methods hold out a small amount of training data, called validation data, and use it to assess the accuracy of the predictor. To find the root of the problem, they conducted a thorough analysis ...