October 2019

The FDA has requested follow-up data... how do I fill in the gaps?

Author: Madison Knapp Posted: 09 October 2019

The best way to evaluate risk and important safety considerations for the patient is going beyond a ‘box-checking’ approach. ADME and DDI are two often overlooked areas of investigation for a new drug because they are often not directly prescribed, but the information you can glean from those data are crucial for painting a complete picture of a drug’s disposition and can help drug developers gather necessary components for a comprehensive data package...

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Why You Need QWBA for Human Radiolabeled ADME Studies

Author: Madison Knapp, Satoshi Ito Posted: 04 October 2019

Quantitative whole body autoradiography (QWBA) is an in vivo study in which a rat (or in some cases mouse) is dosed with radiolabeled test article and at successive time points radioactivity is measured in cross-sectioned slides of the whole animal to show distribution over time. Dosimetry data from QWBA is required for planning hAME radiolabeled mass balance studies in the clinic and can be useful to inform pharmacokinetics (PK) considerations such as distribution. This post describes standard study design and why you should be planning your QWBA studies in advance to make the most of your time and resource investment...

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