RAPS

Bioanalytical Method Validation: FDA Finalizes Guidance From 2013

The US Food and Drug Administration (FDA) on Monday finalized guidance revised in 2013 to help companies validate bioanalytical methods used in human clinical pharmacology, bioavailability (BA) and ...
RAPS

FDA Updates Bioanalytical Method Validation Guidance to Include Biomarkers, Diagnostics

A new draft guidance document released by the US Food and Drug Administration (FDA) aims to assist sponsors of investigational new drug applications (INDs), biologic license applications (BLAs) and ...
JD Supra

Navigating FDA’s Guidance on Validation and Verification of Analytical Testing Methods for Tobacco Products

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 ...
Drug Target Review

Drug development has changed. Bioanalysis is changing with it

As drug developers pursue increasingly complex therapies, traditional bioanalytical approaches are being put to the test. How is the field adapting to meet these new demands?
Technology Networks

Automated Quality Control: Accelerating Lot Release with PCR Assays

Automated quality control using rapid PCR assays is replacing 28-day culture tests, cutting biopharmaceutical lot release ...