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 ...
A new draft guidance document released by the US Food and Drug Administration (FDA) aims to assist sponsors of investigational new drug applications (INDs), biologic license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 ...
The increasing globalization of drug development programs has driven a growing need for rigorous cross-validation of bioanalytical assays across multiple laboratory sites. As bioanalytical methods ...
Announcing a new article publication for BIO Integration journal. Ellagic acid (EA) is a natural polyphenolic compound recognized for bioactive and pharmacologic properties that is found abundantly in ...