The Langmuir binding constants affinity constant (k1) and capacity constant (k2) were the – outcomes reported for the 2 shows the log-transformed data for the generic and reference products. The test/reference (T/R) ratio of the geometric least squares means of the affinity constant was 76.4 (%CV4.4) without acid pre-treatment. The capacity constant T/R ratio was 97.25% (90% CI 95.17 99.38) which was within the pre-specified 80 125% set down in the guidance – – document.
The Langmuir binding constants – affinity constant (k1) and capacity constant (k2) were the outcomes reported for the 2 shows the log-transformed data for the generic and reference products. The test/reference (T/R) ratio of the geometric least squares means of the affinity constant was 76.4 (%CV4.4) without acid pre-treatment. The capacity constant T/R ratio was 97.25% (90% CI 95.17 – 99.38) which was within the pre-specified 80 – 125% set down in the guidance document.
auspar-sevelamer-hydrochloride-151105-cer_0.docx