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 ...

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 ...

Celiac disease (CD) serology plays an important role in CD screening, diagnosis and monitoring of dietary adherence and ongoing mucosal inflammation. Numerous societies have universally recommended CD ...

The Food and Drug Administration (FDA) recently issued a final guidance document, Validation and Verification of Analytical Testing Methods Used for Tobacco Products. This nonbinding guidance provides ...

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 ...

Synthetic urine is engineered to replicate the essential physical and chemical properties of real urine rather than its ...

DUBLIN--(BUSINESS WIRE)--The "Analytical Method Validation, Verification and Transfer Virtual Seminar (Oct 7th - Oct 9th, 2025)" has been added to ResearchAndMarkets.com's offering. Dependable ...

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 ...