Notes to programmer: Plot against actual time since last dosing, if possible. Otherwise, use protocol times. For multiple dose trials, display the entire time course or split into different panels by dosing occasion, as most appropriate For multi-period trials, display overlay treatments separately for each analyte Scale of Y axis may be either identical across all subjects or subject-specific, as most relevant. SPONSOR/PROTOCOL/PRODUCT INFO (page x of x) Figure 14.2-x.x [Arithmetic/Geometric] mean (SD) concentration-time plot per treatment (overlaying) and analyte (separately) Analysis Set : PK analysis set - Values <LLOQ were considered as [zero;missing;LLOQ; LLOQ/Z;…]. PATH DATA/PROGRAM/OUTPUT PRODUCTION STATUS/RUN DMMMYYYY: HHMM Figure 85. Shell for overlaying PK concentration-time profiles Annotations: It is customary to produce arithmetic mean plots for PK data. Given the In some particular multi-arm trials, all groups receive the same treatment but they differ by other characteristics (such as gender, disease status or stage, administration with In these cases, data are reported according to the groups and food, etc…). not the treatment. A footnote indicates how BQL values are managed for the computation of the statistics.
Notes to programmer: Plot against actual time since last dosing, if possible. Otherwise, use protocol times. For multiple dose trials, display the entire time course or split into different panels by dosing occasion, as most appropriate For multi-period trials, display overlay treatments separately for each analyte Scale of Y axis may be either identical across all subjects or subject-specific, as most relevant. SPONSOR/PROTOCOL/PRODUCT INFO (page x of x) Figure 14.2-x.x [Arithmetic/Geometric] mean (SD) concentration-time plot per treatment (overlaying) and analyte (separately) Analysis Set : PK analysis set - Values <LLOQ were considered as [zero;missing;LLOQ; LLOQ/Z;…]. PATH DATA/PROGRAM/OUTPUT PRODUCTION STATUS/RUN DMMMYYYY: HHMM Figure 85. Shell for overlaying PK concentration-time profiles Annotations: It is customary to produce arithmetic mean plots for PK data. Given the In some particular multi-arm trials, all groups receive the same treatment but they differ by other characteristics (such as gender, disease status or stage, administration with food, etc…). In these cases, data are reported according to the groups and not the treatment. A footnote indicates how BQL values are managed for the computation of the statistics.
FDA_PhUSE_WhitePaper_PK_draft_2_30Jan2014v.docx