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