The new FDA Draft Guidance for Transporter DDI is out now
February 23, 2012
In February 2012 the FDA published its Draft Guidance "Drug Interaction Studies - Study Design, Data Analysis, Implications for Dosing, and Labeling Recommendations". This draft guidance accredits the recommendations both the ITC Transporter White Paper and the FDA Decision Trees.Comparison of the transporters in the recently published regulatory documents
| FDA Guidance 2006 |
ITC recommendation 2010 FDA Guidance 2012 |
EMA Guidelines 2010 | |
| P-gp/MDR1 | • | • | • |
| BCRP | • | • | |
| BSEP | • | ||
| OATP1B1 | • | • | |
| OATP1B3 | • | • | |
| OCT1 | • | ||
| OCT2 | • | • | |
| OAT1 | • | • | |
| OAT3 | • | • |
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