Bioassay variability can pose significant challenges due to laboratory conditions, instrumentation, analytical software, cell ...

This talk will focus on doing method validation work in an environment where data is gathered from laboratory information systems and chromatography data systems. We’ll see how these systems can be ...

Join host Neil Lander as he welcomes Katy Rhynard, Associate Director of Laboratory Informatics at Gilead Sciences. In this episode, Katy discusses the intricacies of validating chromatographic ...

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 ...

Sixty-three patients with advanced EGFR-mutant lung cancer at 7 Canadian centers, who were being screened for the ASTRIS trial (ClinicalTrials.gov identifier: NCT02474355), participated in this ...

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

Journal of the Washington Academy of Sciences, Vol. 95, No. 3, SPECIAL ISSUE: SCIENCE AND PUBLIC POLICY (Fall 2009), pp. 113-125 (13 pages) Over the last decade food safety and food control have ...

Evaluation methods rely on assumptions about how validation data and the data one wants to predict, called test data, are related. Traditional methods assume that validation data and test data are ...