Summary
This technical report outlines the accelerated transfer of bioanalytical methods from the PPD Richmond Lab to the PPD Suzhou Lab in China, initiated to support clinical pharmacokinetics (PK) and pharmacodynamics (PD) studies for global sponsors. The report details the transfer of two validated Hybrid LC-MS/MS methods, which faced challenges due to a limited timeframe and complex experimental procedures. The objective included setting up instrumentation, optimizing methods to comply with Chinese regulations, and completing cross-validation before sample analysis. The solutions implemented involved establishing effective communication between labs, utilizing existing instrumentation, and early procurement of key reagents. The successful transfer was completed on time, meeting regulatory requirements, and demonstrating consistency in results between the two labs. The report emphasizes the importance of project coordination and communication in facilitating rapid clinical trial development in China.
