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 ...
LC-MS/MS has been increasingly adopted by clinical laboratories due to the potential it has for increased sensitivity and specificity over more commonly used analytical techniques. However, ...
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 ...
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 ...
Validated next-generation sequencing soon will become necessary in ensuring the safety and efficacy of cell and gene ...
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 ...
Animal testing is often used to evaluate the potential risks, uses, and environmental impacts of chemicals. New Approach Methodologies (NAMs) are technologies and approaches that can potentially ...
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