Bioanalysis (PK) laboratory [16] Critical: Major: Methods used [16.1] Method validation and report [16.2] Results [16.3] TO Other (specify) OPTIONAL COMPLETE Pharmacokinetic analysis [17] Critical: Major: Statistical/pharmacokinetic software Incurred sample reanalysis (ISR) TO PK profile parameters Subject populations Other (specify) COMPLETE OPTIONAL Statistical analysis [18] Critical: Major: Trial design input, sample size calculation Randomisation generation SAP/TFL shells TO Analysis populations & data review meeting Programming & CSV Analysis COMPLETE OPTIONAL Other (specify)
Bioanalysis (PK) laboratory [16] Critical: Major: OPTIONAL TO COMPLETE Methods used [16.1] Method validation and report [16.2] Results [16.3] Other (specify) Pharmacokinetic analysis [17] Critical: Major: OPTIONAL TO COMPLETE Statistical/pharmacokinetic software Incurred sample reanalysis (ISR) PK profile parameters Subject populations Other (specify) Statistical analysis [18] Critical: Major: OPTIONAL TO COMPLETE Trial design input, sample size calculation Randomisation generation SAP/TFL shells Analysis populations & data review meeting Programming & CSV Analysis Other (specify)
WC500146896.docx