title: Toward greater insights on pharmacokinetics and exposure-response relationships for therapeutic biologics in oncology drug development.
abstract: There has been increased interest in optimizing dosing regimens for oncology products over the past decade. Investigations to refine dosing regimens often occur after new drug approval. There is growing focus on the use of exposure-response (ER) approaches to identify optimal dosing regimens for therapeutic biologics. Herein, we describe several recent observations that have informed our thinking on the use of ER analyses in the dose regimen optimization of therapeutic biologics developed to treat cancer.
authors.affiliation: Office of Clinical Pharmacology, Office of Translational Sciences, US Food and Drug Administration, Silver Spring, Maryland, USA.
authors.forename: Y
authors.initials: Y
authors.lastname: Wang
authors.affiliation: Office of Clinical Pharmacology, Office of Translational Sciences, US Food and Drug Administration, Silver Spring, Maryland, USA.
authors.forename: B
authors.initials: B
authors.lastname: Booth
authors.affiliation: Office of Clinical Pharmacology, Office of Translational Sciences, US Food and Drug Administration, Silver Spring, Maryland, USA.
authors.forename: A
authors.initials: A
authors.lastname: Rahman
authors.affiliation: Office of Hematology and Oncology Products, Office of New Drugs, US Food and Drug Administration, Silver Spring, Maryland, USA.
authors.forename: G
authors.initials: G
authors.lastname: Kim
authors.affiliation: Office of Clinical Pharmacology, Office of Translational Sciences, US Food and Drug Administration, Silver Spring, Maryland, USA.
authors.forename: S M
authors.initials: SM
authors.lastname: Huang
authors.affiliation: Office of Clinical Pharmacology, Office of Translational Sciences, US Food and Drug Administration, Silver Spring, Maryland, USA.
authors.forename: I
authors.initials: I
authors.lastname: Zineh
mesh_terms: D000970:Antineoplastic Agents / Q000493:pharmacokinetics* / Q000627:therapeutic use*; D001688:Biological Products / Q000493:pharmacokinetics* / Q000627:therapeutic use*; D003198:Computer Simulation; D004305:Dose-Response Relationship, Drug; D006801:Humans; D008495:Medical Oncology / Q000639:trends*
chemical_list: D000970:Antineoplastic Agents; D001688:Biological Products