Reviews the clinical pharmacology content of a US Prescribing Information Section 8 (Use in Specific Populations) — verifying that each population subsection carries statements traceable to PK, PD, or modelling data, that dose modifications in Section 2 are consistent with Section 8 findings, and that the populations studied are represented. Use when asked to review or QC Section 8 CP content. Do not use for Section 12 review, for SmPC population sections, or for deciding dose modifications.
