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 ...

Deep-Transfer-Learning–Based Natural Language Processing of Serial Free-Text Computed Tomography Reports for Predicting Survival of Patients With Pancreatic Cancer The first approach led to a ...

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 ...

Since the introduction of Inductively Coupled Plasma – Optical Emission Spectroscopy (ICP OES) in 1974, and Inductively Coupled Plasma Mass Spectrometry (ICP-MS) in 1980, these techniques have ...

This talk will explore method validation in the digital lab using integrated and connected systems. Collecting validation data from various lab systems often involves navigating multiple challenges, ...

Early Completion of Model-Assisted Designs for Dose-Finding Trials Accurate assessment of a molecular classifier that guides patient care is of paramount importance in precision oncology. Recent years ...

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 ...

In the information age, bridging the gap between data and clinical application is crucial. The Center for Clinical and Translational Science (CCTS) is making significant investments in this area. Over ...

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 ...

In pharmaceutical manufacturing, cleaning validation is an essential stage of verifying that the manufacturing process is suitable. As an integral stage of the cleaning validation program, analytical ...