Quantitative Mechanistic Modeling in Support of Pharmacological Therapeutics Development in Immuno-Oncology

immuno-oncology, mechanistic models, tumor vs. immune system, systems pharmacology, pharmacokinetics, pharmacodynamics, molecular and cellular biomarkers

There has been significant growth in the development of immuno-modulating pharmacological treatments for various cancers following the approval of the first immune checkpoint inhibitor. Challenges in immuno-oncology (IO) drug development are complex and span from the discovery phase to late-…

Apr 30^th • 12 mins read

Confounding factors in exposure–response analyses and mitigation strategies for monoclonal antibodies in oncology

monoclonal antibodies, E-R analyses, tumour growth inhibition, drug development

Dose selection and optimization is crucial in drug development to maximize benefits for all patients. Exposure–response (E-R) analysis is useful for dose-selection strategy, but in oncology, prognostic factors can confound the analysis, especially for monoclonal antibodies. The review addr…

Nov 20^th • 12 mins read

Discordance Between Child-Pugh and National Cancer Institute Classifications for Hepatic Dysfunction: Implications on Dosing Recommendations for Oncology Compounds

FDA, hepatic dysfunction, child-pugh, national cancer institute, dosing, oncology compounds

The FDA and European Medicines Agency recommend using Child-Pugh classification for pharmacokinetic evaluation in noncancer subjects with hepatic impairment (HI). Dosing recommendations for oncology compounds for patients with HI are commonly based on Child-Pugh classification. In oncology …

Jul 20^th • 18 mins read