See Other Case Studies Mass Balance Study Partnering with Biotechnology Companies EU Biotech Needs First-in- Human FDA Support NEED n A client required higher sensitivity at lower sample volume to conduct sampling for a bioequivalence study n The existing RIA method did not have the sensitivity to reduce the sample volume below 4mL to achieve a LLOQ of 2pg/mL APPROACH n Developed and validated an LC-MS/MS method for Desmopressin using a four-fold reduced sample volume of 1mL n Performed a comparison between the RIA and the LC-MS/MS method by analyzing human samples using both methods BENEFITS n With the new method the client successfully reduced the blood draw volume and increased the number of time points to support the bioequivalence study n As an addition

Join for free to read