The study demonstrates the accuracy and utility of Omega Laboratories’ analytical method for detecting cannabinoids in breath samples collected using Cannabix Technologies’ Breath Collection Unit and ...

The attributes of the DS or DP that are to be tested to obtain the necessary information about product quality safety and efficacy are determined during the Drug Development stage. The information ...

In the pharmaceutical industries, validation of analytical methods is a critical process that confirms the reliability and appropriateness of a method for its intended application. Method validation ...

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 ...

The key statistical objective in IVD device evaluation is establishing performance criteria while minimizing bias and maximizing precision. While the statistical considerations and methodologies ...

Stay ahead of the curve with our 2nd edition Analytical Method Validation & Lifecycle Management Masterclass. Learn about the latest ICH guidelines, including the new ICH Q14 for analytical method ...

The last two decades have witnessed the steady growth of the protein drug market. As original recombinant products come off patent, generics/ biosimilars are also beginning to be manufactured. The ...

Stay ahead of the curve with our 2nd edition Analytical Method Validation & Lifecycle Management Masterclass - US Edition. Learn about the latest ICH guidelines, including the new ICH Q14 for ...