title: Why therapeutic drug monitoring is needed for monoclonal antibodies and how do we implement this?
abstract: Monoclonal antibodies (mAbs) have improved clinical outcomes for many therapeutic indications. However, extensive between-subject variability (BSV) contributes to therapeutic failures through suboptimal exposure. Therapeutic drug monitoring (TDM) is routinely implemented for inflammatory diseases; improving outcomes and reducing treatment costs. BSV can be more extensive with anticancer mAbs. Clearance BSV is associated with patient factors and disease burden, suggesting that TDM could benefit anticancer mAbs, as was seen with inflammatory disease, however, there are many hurdles.
authors.affiliation: Projections Research, Phoenixville, Pennsylvania, USA.
authors.forename: D R
authors.initials: DR
authors.lastname: Mould
mesh_terms: D000893:Anti-Inflammatory Agents / Q000009:adverse effects / Q000493:pharmacokinetics / Q000627:therapeutic use*; D000911:Antibodies, Monoclonal / Q000009:adverse effects / Q000493:pharmacokinetics / Q000627:therapeutic use*; D000970:Antineoplastic Agents / Q000009:adverse effects / Q000493:pharmacokinetics / Q000627:therapeutic use*; D003661:Decision Support Techniques; D004305:Dose-Response Relationship, Drug; D054796:Drug Dosage Calculations; D016903:Drug Monitoring / Q000379:methods*; D006801:Humans; D011237:Predictive Value of Tests; D016896:Treatment Outcome
chemical_list: D000893:Anti-Inflammatory Agents; D000911:Antibodies, Monoclonal; D000970:Antineoplastic Agents