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 ...
The European Medicines Agency (EMA) on Thursday released for public consultation the International Council of Harmonisation’s (ICH) M10 guideline, which aims to help sponsors improve the quality and ...
As drug developers pursue increasingly complex therapies, traditional bioanalytical approaches are being put to the test. How ...
Targeted metabolite assays that measure tens or hundreds of pre-selected metabolites, typically using liquid chromatography–mass spectrometry, are increasingly being developed and applied to metabolic ...
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 ...
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