Toward Greater Insights on Pharmacokinetics and Exposure–Response Relationships for Therapeutic Biologics in Oncology Drug Development

Wang, Y; Booth, B; Rahman, A; Kim, G; Huang, SM; Zineh, I

doi:10.1002/cpt.628

Cited by 49Biosimilars and Bioanalytical MethodsStatistical Methods in Clinical TrialsMonoclonal and Polyclonal Antibodies Research

Toward Greater Insights on Pharmacokinetics and Exposure–Response Relationships for Therapeutic Biologics in Oncology Drug Development

Wang, Y, Booth, B, Rahman, A, Kim, G, Huang, SM, Zineh, I·2017·Clinical Pharmacology & Therapeutics

DOI 10.1002/cpt.628

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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.

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“At the investigational new drug (IND) enabling stage, integrated PK/PD knowledge along with safety studies serve a critical role in translating preclinical findings to first‐in‐human dose and regimen selection in the clinic.52, 53”
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Authors: Wang, Y., Booth, B., Rahman, A., Kim, G., Huang, S., & Zineh, I.
Affiliations: United States Food and Drug Administration (US)
Office of Clinical Pharmacology, Office of Translational Sciences, US Food and Drug Administration Silver Spring Maryland USA
Corresponding author: Wang, Y
Venue: Clinical Pharmacology & Therapeutics
Publisher: Wiley
Published: 2017-03-15
Volume: 101
Issue: 5
Pages: 582-584
ISSN: 0009-9236 (ISSN-L)
1532-6535
DOI: 10.1002/cpt.628
OpenAlex: W2578064406
Cited by: 48
References: 6
Citations by year: 2026: 1 · 2025: 3 · 2024: 7 · 2023: 7 · 2022: 3 · 2021: 3 · 2020: 6 · 2019: 6 · 2018: 4 · 2017: 8
FWCI: 2.96
Type: journal article
Language: en
Open access: closed
Licence: onlinelibrary.wiley.com/termsAndConditions#vor (vor)
Locations: Clinical Pharmacology & Therapeutics (publishedVersion)
PubMed (publishedVersion)
Topics: Life Sciences › Immunology and Microbiology › Immunology › Biosimilars and Bioanalytical Methods
Physical Sciences › Mathematics › Statistics and Probability › Statistical Methods in Clinical Trials
Health Sciences › Medicine › Radiology, Nuclear Medicine and Imaging › Monoclonal and Polyclonal Antibodies Research
Keywords: pharmacokinetics, exposure-response relationship, biologic therapeutics, anticancer drug development, dosing regimen optimization, cancer therapy, biologic drugs
MeSH terms: Antineoplastic Agents, Biological Products, Computer Simulation, Dose-Response Relationship, Drug, Humans, Medical Oncology

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Toward Greater Insights on Pharmacokinetics and Exposure–Response Relationships for Therapeutic Biologics in Oncology Drug Development

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