The attributes of the DS or DP that are to be tested to obtain the necessary information about product quality safety and efficacy are determined during the Drug Development stage. The information ...

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 ...

Researchers develop a molecular testing-based fast-throughput method for the rapid and early detection of Salmonella ...

The Global Bioprocess Validation Market presents key opportunities driven by the growing demand for biologics and biosimilars ...

CS Analytical Laboratory, the world's only FDA regulated contract laboratory exclusively dedicated to providing regulatory ...

Per- and polyfluoroalkyl substances (PFAS), often referred to as “forever chemicals,” are a very diverse set of organic chemical compounds ...

Owkin shares promising validation results for BRCAura RUO, a clinical-grade research-use-only AI product designed to screen for germline BRCA1/2 mutations (gBRCAm) directly from digitized breast ...

Innovative sweat sampling techniques could revolutionize diagnostics, offering insights into glucose levels and environmental ...

The FDA provided constructive clinical feedback during the Type C meeting regarding the Company’s strategy to pursue a Biologic License Application. This feedback provides a clear and feasible ...

Advanced technologies in pharma manufacturing necessitate a redefinition of the Qualified Person's role, focusing on digital ...

For drug discovery and biomarker development, peptide-level validation strengthens confidence that selected targets represent ...