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 ...

Anyone relying on the particle size results from DLS or liquid particle counters should consider and address how the data will be used and how to assure the quality of the final results. This ...

The US Food and Drug Administration (FDA) has released a final guidance document with immediate effect advising sponsors on ...

GenoSafe advances CLIA pathway for transatlantic ATMP development CLIA registration enables GenoSafe to support testing of ...

Estimation of population attributable fractions based on integrated global cancer incidence data, 1990-2021. Utilizing cancer community outreach and engagement to explain impact of age, income, ...

Efficacy, Safety, Pharmacokinetics, and Immunogenicity of DRL-Trastuzumab Versus Herceptin in Human Epidermal Growth Factor Receptor 2–Positive Metastatic Breast Cancer: A Randomized Controlled Trial ...

Method validation in R&D and QC has evolved beyond statistical evaluation to become a core compliance-driven process. Today, it requires full integration into laboratory operations and the generation ...

The FDA Process Validation training highlights opportunities in enhancing comprehension of constant process verification aligned with lifecycle concepts. It addresses early R&D phases through ...

Introduction For priority populations, such as Indigenous children, school-based screening programmes can increase equitable access to care. However, current traditional economic measures evaluating ...

Triple click chemistry has revolutionized chemical synthesis with its simplicity and efficiency, allowing for the quick and selective assembly of complex molecules. Now, in a recent study, researchers ...

This suite automates the commissioning, qualification, and validation (CQV) of processes, equipment, and systems. It includes three AI-enabled applications: Together, these systems work in tandem to ...