pharmaphorum

How lab automation reinforces regulatory compliance for bioanalytical method validation

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 ...
Labroots

Validation of clinical LC-MS/MS methods: What you need to know

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, ...
Labroots

Validating Chromatographic Methods: Challenges, Tools, and Optimization

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 ...
MD&M East

How to Use Surrogate Devices for Validation of Destructive Test Methods for Combination Product Design Verification

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 ...
National Academies of Sciences%2c Engineering%2c and Medicine

Variability and Relevance of Current Laboratory Mammalian Toxicity Tests and Expectations for New Approach Methods (NAMs) for use in Human Health Risk Assessment

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 ...