Studies Designed
for FDA Submission
Optivia Delivers FDA Ready Reports
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OptiDDI&trade Suite of FDA Compliant DDI Assays
The OptiDDI&trade Suite is a comprehensive group of in vitro transporter assay services to be used for FDA submissions for the assessment of transporter mediated drug-drug interactions (DDIs). The experiments were designed in accordance with the ITC Transporter White Paper and the recommendations approved by the FDA Advisory Committee on Pharmaceutical Science and Clinical Pharmacology.
The OptiDDI&trade Suite consists of the OptiProfile-Essential&trade, OptiDDI-IC50&trade, OptiDDI-Substrate&trade and OptiDDI-Km&trade services and includes all seven FDA transporters: P-gp (MDR1, ABCB1), BCRP (ABCG2), OAT1 (SLC22A6), OAT3 (SLC22A8), OATP1B1 (SLCO1B1), OATP1B3 (SLCO1B3) and OCT2 (SLC22A2).
OptiProfile-Essential&trade
OptiProfile-Essential&trade is a screen with each of the seven FDA transporters testing for inhibition by the customer compound. Each assay is performed at a single concentration and all points are in triplicate.
OptiDDI-IC50&trade
OptiDDI-IC50&trade is a full dose response study for a transporter of interest that assesses inhibition of the transport of a known substrate by the customer compound. It is used to determine the inhibition constant, IC50. A seven point curve is generated with a vehicle blank plus six concentrations of the customer compound. All points are in triplicate.
OptiDDI-Substrate&trade
OptiDDI-Substrate&trade is used to determine whether the customer compound is a substrate of a given transporter. Flux of the customer compound is measured alone and also in the presence of two known inhibitors recommended by the ITC. It is performed at a single concentration of the customer compound. All points are in triplicate.
OptiDDI-Km&trade
OptiDDI-Km&trade is a full dose response substrate kinetic study with the customer compound for a transporter of interest. It is used to determine saturation of transport and Km and Vmax. A seven point curve is generated with a vehicle blank plus six concentrations of the customer compound. All points are in triplicate.
The OptiDDI&trade Suite is a comprehensive group of in vitro transporter assay services to be used for FDA submissions for the assessment of transporter mediated drug-drug interactions (DDIs). The experiments were designed in accordance with the ITC Transporter White Paper and the recommendations approved by the FDA Advisory Committee on Pharmaceutical Science and Clinical Pharmacology.
The OptiDDI&trade Suite consists of the OptiProfile-Essential&trade, OptiDDI-IC50&trade, OptiDDI-Substrate&trade and OptiDDI-Km&trade services and includes all seven FDA transporters: P-gp (MDR1, ABCB1), BCRP (ABCG2), OAT1 (SLC22A6), OAT3 (SLC22A8), OATP1B1 (SLCO1B1), OATP1B3 (SLCO1B3) and OCT2 (SLC22A2).
OptiProfile-Essential&trade
OptiProfile-Essential&trade is a screen with each of the seven FDA transporters testing for inhibition by the customer compound. Each assay is performed at a single concentration and all points are in triplicate.
OptiDDI-IC50&trade
OptiDDI-IC50&trade is a full dose response study for a transporter of interest that assesses inhibition of the transport of a known substrate by the customer compound. It is used to determine the inhibition constant, IC50. A seven point curve is generated with a vehicle blank plus six concentrations of the customer compound. All points are in triplicate.
OptiDDI-Substrate&trade
OptiDDI-Substrate&trade is used to determine whether the customer compound is a substrate of a given transporter. Flux of the customer compound is measured alone and also in the presence of two known inhibitors recommended by the ITC. It is performed at a single concentration of the customer compound. All points are in triplicate.
OptiDDI-Km&trade
OptiDDI-Km&trade is a full dose response substrate kinetic study with the customer compound for a transporter of interest. It is used to determine saturation of transport and Km and Vmax. A seven point curve is generated with a vehicle blank plus six concentrations of the customer compound. All points are in triplicate.