FDA DataFit: an introduction Blog Post

Explore FDA DataFit, a project ensuring high-quality, compliant data to streamline drug reviews, reduce delays, and advance efficient decision-making.

Bioanalytical Calibration Curves Blog Post

At the request of a reader, I have decided to extend my series on bioanalysis to include another topic: calibration curves. The calibration curve is they keystone of bioanalysis. It…

Radiometric Analysis Blog Post

One of the oldest methods used for the quantitation of drug molecules is radiometric analysis. This generally involves quantitation of radiation from beta-emitting radioactive isotopes such as 14C, 3H or…

FDA JumpStart: an introduction Blog Post

Discover FDA JumpStart, a ground-breaking service accelerating drug reviews by enhancing data quality, identifying risks, and streamlining submissions.

Understanding LC/MS/MS Blog Post

The most common bioanalytical method in use today is LC/MS/MS, or liquid chromatography (LC) tandem mass spectrometry (MS). This is a very versatile, robust, and sensitive methodology that is used...