Following the trend of other regulators, the European Medicines Agency (EMA) is taking steps to reduce the need for animal testing. The agency has issued a draft qualification opinion for a new ...

Sponsors will now be able to submit preclinical toxicology data using virtual animal controls instead of a standard animal ...

One of my more aspirational career goals has been to increase the efficiency of validation testing without lowering the quality. Testing of automated systems is essential to ensure quality in both the ...

Regular quality control testing of medical radiological equipment improves clinical image quality and reduces radiation exposure of patients. Radiography and mammography machines, for example, may ...

Safety and efficacy are the two regulatory benchmarks for pharmaceutical products. Microbial contamination of products is an important aspect of product quality that can affect both safety and ...

False discovery rate (FDR) control has become an essential tool in the analysis of high-dimensional data, where thousands or millions of simultaneous hypotheses are tested. The aim is to limit the ...