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 ...

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 ...

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