A big portion of our in vitro ADME assays are performed using intact cells which have special requirements for assay conditions. To address these requirements these studies are performed in a separate lab dedicated to cell-based work. Why don’t we take a closer look at what goes on in our cell lab? Read more
Our ADME-Tox e-book series, launched in April 2017, was just completed by the release of the fifth book “Permeability and transporters”. The e-book series was initiated to provide an easy-to-read source of information for those willing to learn more about ADME-Tox. The e-books have been written by our study directors, elucidating the science behind their areas of expertise for the readers. Read more
The new FDA draft guidance on DDI studies – how does it affect in vitro studies?
1 December 2017
Recently FDA released new draft guidance on drug-drug interaction (DDI) studies. Compared to the previous one issued in 2012, also the structure is revised as there is now two complementary documents. The “In Vitro Metabolism- and Transporter –Mediated Drug-Drug Interaction Studies” focuses on in vitro approaches to evaluate potential interaction risk, Read more