Study finds MPS2 scores are highly reproducible across DRE and non-DRE urine samples alike. “This study reinforces the value of MPS2 as a non-invasive diagnostic tool that delivers consistent and ...

Good HPLC methods must satisfy both technical requirements (sensitivity, specificity, linearity, accuracy and precision) as well as business needs (reliability in routine use and a run time ...

Computerized systems are those which comprise the components shown in Figure 1.1, namely, a computer system and a controlled function which is operating within its specified working environment. The ...

In-line UV spectroscopy allows real-time monitoring of cleaning processes, enhancing process control and compliance with Pharma 4.0 goals. The method provides continuous detection of residual cleaning ...

CHICAGO--(BUSINESS WIRE)--Tempus, a leader in artificial intelligence and precision medicine, today announced results from validation studies demonstrating the reliable analytical performance of the ...

Specifications ensure drug substances/products meet acceptance criteria, forming a foundation for robust control strategies. Validated methods must be fit for purpose, with MODRs providing flexibility ...

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 ...