The new FDA draft guidance on DDI studies – how does it affect in vitro studies?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Recently FDA released new draft guidance on drug-drug interaction (DDI) studies.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