Case Study

Bioanalytical Support of Oncology Studies

Bioanalytical Support of Oncology Studies

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See Other Case Studies Mass Balance Study Partnering with Biotechnology Companies EU Biotech Needs First-in- Human FDA Support BENEFITS n Data delivered to the client within their requested timelines to ensure they were able to assess the adverse events based on the available PK and ADA results n Drug dosages could be adopted appropriately to assure patient well-being NEED n PK and ADA sample analysis using a proprietary Enzyme-linked Immunosorbent assay (ELISA) was required to support a PI oncology study in subjects with metastases n Immediate analysis was required for adverse events for this clinical study over a four year period. The sample arrival dates were not predictable however turnaround time for sample analysis and data delivered to the client was t

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