Intra-Individual Reproducibility of the Non-Invasive Assessment of the Portal Circulation

"The FDA has indicated that liver function diagnostic testing with stable isotope labeled cholates would be considered a drug/device combination product. The drugs administered at each test visit will be:~20 mg Cholate-24-13C, IV (in the vein), dissolved in NaHCO3 and mixed with albumin.~40 mg Cholate-2,2,4,4-d4, oral, dissolved in NaHCO3 and mixed with juice.~The 3 test visits will be on separate days within a span of 30 days"