title: Should Therapeutic Drug Monitoring for Monoclonal Antibodies Remain the Exception or Become the Norm?
abstract: Therapeutic drug monitoring (TDM) aims to maintain circulating drug concentrations at a desired level to optimize clinical outcome. The vast majority of marketed drugs do not require TDM, suggesting the clinical benefit of TDM has not been sufficiently demonstrated in most cases. With the continued emergence and prominence of monoclonal antibodies (mAbs) as drugs, especially in inflammation and cancer therapeutic areas, we are at a juncture to consider applicability of TDM for mAbs.
authors.affiliation: Department of Clinical Pharmacology, Genentech, South San Francisco, California, USA.
authors.forename: M
authors.initials: M
authors.lastname: Stroh
authors.affiliation: Department of Clinical Pharmacology, Genentech, South San Francisco, California, USA.
authors.forename: B L
authors.initials: BL
authors.lastname: Lum
mesh_terms: D000911:Antibodies, Monoclonal / Q000493:pharmacokinetics / Q000494:pharmacology*; D004305:Dose-Response Relationship, Drug; D016903:Drug Monitoring / Q000379:methods*; D006801:Humans; D016219:Immunotherapy, Adoptive / Q000379:methods; D009369:Neoplasms / Q000188:drug therapy*
chemical_list: D000911:Antibodies, Monoclonal