Cited by 192Monoclonal and Polyclonal Antibodies ResearchPharmaceutical studies and practicesStatistical Methods in Clinical Trials

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Fixed Dosing Versus Body Size—Based Dosing of Monoclonal Antibodies in Adult Clinical Trials

Wang, Diane D., Zhang, Shuzhong, Zhao, Hong, Men, Angela Y., Parivar, Kourosh·2009·The Journal of Clinical Pharmacology

DOI 10.1177/0091270009337512

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Abstract

Although without clear scientific rationale, body size—based dosing is often used for administering monoclonal antibodies (mAbs). This simulation study compared the performance of body size—based and fixed dosing in reducing pharmacokinetic (PK) and/or pharmacodynamic (PD) variability in adults for 12 mAbs with published population PK and/or PD models. At the population level, 95th percentile intervals of concentration‐time profiles, distribution, and variability of exposure for 1000 subjects after both dosing approaches were examined. At the individual level, the difference between the exposures of patients with extreme body sizes from the typical exposure following both approaches was compared. The results show that the 2 dosing approaches perform similarly across the mAbs investigated with fixed dosing being better for some mAbs and body size—based dosing being better for the others. Based on this finding, we recommend using fixed dosing in first‐in‐human (FIH) adult studies because it offers other advantages. When sufficient data become available, a full assessment of body size effect on PK/PD should be conducted to determine the optimal dosing approach for phase 3 trials. Other factors that may affect the selection of dosing approach were also discussed. Dosing approach for mAbs in the pediatric population is out of the scope of this study.

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Clinical relevance of mutations and gene-expression changes in adult acute myeloid leukemia with normal cytogenetics: are we ready for a prognostically prioritized molecular classification?
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Effect of Genetic Variation in the Organic Cation Transporter 1, OCT1, on Metformin Pharmacokinetics
Shu, Y., Brown, C., Castro, R. A., Shi, R., Lin, E., Owen, R., Sheardown, S., Yue, L., Burchard, E. G., Brett, C., et al. (2007) · Clinical Pharmacology & Therapeutics · doi:10.1038/sj.clpt.6100275 · Cited by 480
Drug interactions in cancer therapy
Scripture, C. D., & Figg, W. D. (2006) · Nature reviews. Cancer · doi:10.1038/nrc1887 · Cited by 368
Clinical pharmacokinetics of bevacizumab in patients with solid tumors
Lü, J., Bruno, R., Eppler, S., Novotny, W. F., Lum, B. L., & Gaudreault, J. (2008) · Cancer Chemotherapy and Pharmacology · doi:10.1007/s00280-007-0664-8 · Cited by 364
Dose calculation of anticancer drugs: a review of the current practice and introduction of an alternative.
Gurney, H. (1996) · Journal of Clinical Oncology · doi:10.1200/jco.1996.14.9.2590 · Cited by 363
Role of Body Surface Area in Dosing of Investigational Anticancer Agents in Adults, 1991-2001
Baker, S. D., Verweij, J., Rowinsky, E. K., Donehower, R. C., Schellens, J. H. M., Grochow, L. B., & Sparreboom, A. (2002) · JNCI Journal of the National Cancer Institute · doi:10.1093/jnci/94.24.1883 · Cited by 286
Population pharmacokinetics of trastuzumab in patients With HER2+ metastatic breast cancer
Bruno, R., Washington, C. B., Lü, J., Liebérman, G., Banken, L., & Klein, P. M. (2005) · Cancer Chemotherapy and Pharmacology · doi:10.1007/s00280-005-1026-z · Cited by 248
Specific EGFR Mutations Predict Treatment Outcome of Stage IIIB/IV Patients With Chemotherapy-Naive Non–Small-Cell Lung Cancer Receiving First-Line Gefitinib Monotherapy
Yang, C.-H., Yu, C., Shih, J., Chang, Y., Hu, F., Tsai, M.-C., Chen, K., Lin, Z., Huang, C.-J., Shun, C., et al. (2008) · Journal of Clinical Oncology · doi:10.1200/jco.2007.15.6695 · Cited by 238
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Sawyer, M. B., & Ratain, M. J. (2001) · Investigational New Drugs · doi:10.1023/a:1010639201787 · Cited by 223

Show all 29 references

Research works printed but not linked: 1

Guru V, 2004, How do gender, body surface area (BSA) and body mass index (BMI) impact on mortality of patients undergoing isolated coronary artery bypass graft (CABG) surgery in Ontario, 57th Annual Meeting of Canadian Cardiovascular Congress, 47, 383

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Authors: Wang, D. D., Zhang, S., Zhao, H., Men, A. Y., & Parivar, K.
Affiliations: Pfizer (United States) (US)
United States Food and Drug Administration (US)
Corresponding author: Wang, Diane D.
ORCID: Zhang, Shuzhong
Zhao, Hong
Venue: The Journal of Clinical Pharmacology
Publisher: Wiley
Published: 2009-09
Volume: 49
Issue: 9
Pages: 1012-1024
ISSN: 0021-9754 (ISSN-L)
0091-2700
1552-4604
DOI: 10.1177/0091270009337512
OpenAlex: W2015186160
Cited by: 192
References: 29
Citations by year: 2026: 7 · 2025: 17 · 2024: 5 · 2023: 9 · 2022: 14 · 2021: 11 · 2020: 18 · 2019: 20 · 2018: 11 · 2017: 17 · 2016: 8 · 2015: 13 · 2014: 15 · 2013: 10 · 2012: 7
FWCI: 4.28
Type: journal article
Language: en
Open access: closed
Licence: onlinelibrary.wiley.com/termsAndConditions#vor (vor, 1283 d)
Locations: The Journal of Clinical Pharmacology (publishedVersion)
PubMed (publishedVersion)
Topics: Life Sciences › Immunology and Microbiology › Immunology › Monoclonal and Polyclonal Antibodies Research
Health Sciences › Medicine › Pediatrics, Perinatology and Child Health › Pharmaceutical studies and practices
Physical Sciences › Mathematics › Statistics and Probability › Statistical Methods in Clinical Trials
Keywords: monoclonal antibodies, fixed dosing, dose selection, pharmacokinetic variability, pharmacodynamic variability, exposure distribution
MeSH terms: Adult, Antibodies, Monoclonal, Body Surface Area, Body Weight, Clinical Trials as Topic, Computer Simulation, Dose-Response Relationship, Drug, Humans, Models, Biological

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Fixed Dosing Versus Body Size—Based Dosing of Monoclonal Antibodies in Adult Clinical Trials

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