Attachment: Extract from Clinical Evaluation Report: Nivolumab

Coefficient of variation. DILI. Drug-induced liver injury. DLT. Dose limiting toxicity. DoR. ... The inter-individual variability in PK parameters was considered to be modest with coefficients of variation being < 30% for C max and AUC, ... The dosage regimen for dacarbazine used in this study is the same as that recommended . ................
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