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

An expert illustrates why test method validation is important in the real world. José Ignacio Mora Tom was ready to send the multi-cavity fixtures. I asked him to perform a Gage Repeatability and ...

Biotia, a company advancing infectious disease diagnostics for challenging infections, today announced the publication of a pivotal clinical validation study in the American Society for Microbiology ...

When clinicians contemplate the use of a new predictive technology in their practice, such as a nomogram, there is always a question of whether the new test is beneficial to their own clinical ...