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 ...

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 ...

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 ...

Nucleic acid extraction is a fundamental step in unlocking the genetic information contained within biological samples. Isolated nucleic acids are the basis for a multitude of analyses and ...

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 ...