Bioanalytical method development and validation are at the forefront of ensuring rigorous, reproducible and reliable data in both drug development and clinical diagnostics. The field encompasses the ...

The FDA has released a draft guidance outlining how drug developers can validate new approach methodologies (NAMs) as ...

FDA’s NAM framework emphasizes context of use, human biological relevance, technical characterization, and fit-for-purpose ...

Join host Neil Lander as he sits down with Margaret Maziarz, Principal Scientist at Waters Corporation, to discuss the latest tools and strategic approaches to optimizing method development. Margaret ...

This course will provide you with the requisite scientific knowledge and understanding of analytical method lifecycle management, which includes the activities of validation, verification, transfer, ...

Due to the remarkable success of the Research Topic '<a href=" of Health and Disease in Veterinary Science' and the rapidly evolving subject area, we are pleased to launch Volume II for this topic.<br ...

In pharmaceutical manufacturing, cleaning validation is an essential stage of verifying that the manufacturing process is suitable. As an integral stage of the cleaning validation program, analytical ...

This suite automates the commissioning, qualification, and validation (CQV) of processes, equipment, and systems. It includes three AI-enabled applications: Together, these systems work in tandem to ...

This course will provide you with the requisite scientific knowledge and understanding of analytical method lifecycle management, which includes the activities of validation, verification, transfer, ...