Incurred samples reanalysis experiment for tacrolimus determination in VAMS and whole blood samples obtained from pediatric patients after renal transplantation.

Following guidelines for bioanalytical validation (EMA): Incurred sample reanalysis should be done at least in the following situations: • toxicokinetic studies once per species • all pivotal bioequivalence trials • first clinical trial in subjects • first patient trial • first trial in patients with impaired hepatic and/or renal function遵循欧洲药品管理局（EMA）的生物分析验证指南：实际受试样本重分析（incurred sample reanalysis）应至少在以下情形中开展： • 针对每一物种开展一次的毒代动力学研究 • 全部关键生物等效性试验 • 首次针对受试者开展的临床试验 • 首次以患者为受试对象的临床试验 • 首次针对肝肾功能受损患者开展的临床试验