The 2020 FDA guidance for in vitro DDI studies – new things to consider?
4 May 2020
In January 2020, the Final DDI Guidance for Industry was published. Similarly to the draft guidance, there are separate documents for in vitro and clinical drug interaction studies, which are to be used systemically to assess DDI potential. We’ll focus here on conducting in vitro DDI studies according the In Vitro Drug Interaction Studies - Cytochrome P450 Enzyme- and Transporter-Mediated Drug Interactions Guidance.Read more
In the cell lab
10 April 2019
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
The ADME-Tox e-book series completed
8 October 2018
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The new FDA draft guidance on DDI studies – how does it affect in vitro studies?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Recently FDA released new draft guidance on drug-drug interaction (DDI) studies.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
