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 ...

Validated next-generation sequencing soon will become necessary in ensuring the safety and efficacy of cell and gene ...

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

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, ...

Laboratory-based design verification testing (DVT) of combination products and medical devices must be performed to demonstrate that the device meets the performance requirements that were set in the ...

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 ...

The U.S. Department of Agriculture’s Agricultural Marketing Service released two final guidance documents on detectability testing and procedures to validate a refining process for use in evaluating ...

The Workshop is planned to highlight, review, and discuss issues related to the implementation of XRF methodologies, including addressing recommendations for compliance to technical requirements of ...

Real world analysis of VTE incidence in lung cancer: A comprehensive assessment of the Khorana score and other clinical factors in predicting VTE incidence. This is an ASCO Meeting Abstract from the ...