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

The DOI matches its Crossref record; 30 of the 30 references it cites were found in a registry or an index.

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

Open this paper in CoChat — free account

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.

Integrity signals

Registry

Crossref · 10.1177/0091270009337512

Cites

30 of 30 references verified0 citation errors · 0 not checkable

Statistics

Recomputing p-values needs the paper’s full text.

Claims the paper makes

This paper’s full text isn’t openly available, so its claims and self-check weren’t run. The registry and citation checks still apply.

Claims other papers make about this one

Each is checked against this paper’s own text: does it say what the citing paper says it does?

Antibody Pharmacokinetics and Pharmacodynamics
Lobo, E. D., Hansen, R. J., & Balthasar, J. P. (2004) · Journal of Pharmaceutical Sciences · doi:10.1002/jps.20178 · Cited by 909
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?
Mrózek, K., Marcucci, G., Paschka, P., Whitman, S. P., & Bloomfield, C. D. (2006) · Blood · doi:10.1182/blood-2006-06-001149 · Cited by 554
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
Body Surface Area as a Determinant of Pharmacokinetics and Drug Dosing
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

Sorted by citations

Population Pharmacokinetics of Therapeutic Monoclonal Antibodies
Dirks, N. L., & Meibohm, B. (2010) · Clinical Pharmacokinetics · doi:10.2165/11535960-000000000-00000 · Cited by 500
Subcutaneous Administration of Biotherapeutics: An Overview of Current Challenges and Opportunities
Bittner, B., Richter, W., & Schmidt, J. (2018) · BioDrugs · doi:10.1007/s40259-018-0295-0 · Cited by 447
Pharmacokinetics of monoclonal antibodies and Fc-fusion proteins
Liming, L. (2017) · Protein & Cell · doi:10.1007/s13238-017-0408-4 · Cited by 407
Review of therapeutic drug monitoring of anticancer drugs part two – Targeted therapies
Widmer, N., Bardin, C., Chatelut, É., Paci, A., Beijnen, J. H., Levêque, D., Veal, G. J., & Astier, A. (2014) · European Journal of Cancer · doi:10.1016/j.ejca.2014.04.015 · Cited by 299
Evaluation of dosing strategy for pembrolizumab for oncology indications
Freshwater, T., Kondic, A. G., Ahamadi, M., Li, C. H., de Greef, R., de Alwis, D. P., & Stone, J. A. (2017) · Journal for ImmunoTherapy of Cancer · doi:10.1186/s40425-017-0242-5 · Cited by 277
Preference for subcutaneous or intravenous administration of trastuzumab in patients with HER2-positive early breast cancer (PrefHer): an open-label randomised study
Pivot, X., Gligorov, J., Müller, V., Barrett-Lee, P., Verma, S., Knoop, A., Curigliano, G., Semiglazov, V., López-Vivanco, G., Jenkins, V., et al. (2013) · The Lancet Oncology · doi:10.1016/s1470-2045(13)70383-8 · Cited by 230
Pharmacokinetics and Pharmacodynamics of Monoclonal Antibodies
Mould, D. R., & Green, B. (2010) · BioDrugs · doi:10.2165/11530560-000000000-00000 · Cited by 207
Design and Conduct Considerations for First‐in‐Human Trials
Shen, J., Swift, B., Mamelok, R. D., Pine, S. O., Sinclair, J. H., & Attar, M. (2018) · Clinical and Translational Science · doi:10.1111/cts.12582 · Cited by 182
Recombinant factor IX-Fc fusion protein (rFIXFc) demonstrates safety and prolonged activity in a phase 1/2a study in hemophilia B patients
Shapiro, A. D., Ragni, M. V., Valentino, L. A., Key, N. S., Josephson, N. C., Powell, J. S., Cheng, G. Y.-M., Thompson, A. R., Goyal, J., Tubridy, K. L., et al. (2011) · Blood · doi:10.1182/blood-2011-07-367003 · Cited by 172
Fixed Dosing of Monoclonal Antibodies in Oncology
Hendrikx, J. J. M. A., Haanen, J. B. A. G., Voest, E. E., Schellens, J. H. M., Huitema, A. D. R., & Beijnen, J. H. (2017) · The Oncologist · doi:10.1634/theoncologist.2017-0167 · Cited by 168
A Guide to Rational Dosing of Monoclonal Antibodies
Bai, S., Jorga, K. M., Xin, Y., Jin, D., Zheng, Y., Damico‐Beyer, L. A., Gupta, M., Tang, M. T., Allison, D. E., Lu, D., et al. (2012) · Clinical Pharmacokinetics · doi:10.2165/11596370-000000000-00000 · Cited by 166
The Relationship between Drug Clearance and Body Size
McLeay, S. C., Morrish, G. A., Kirkpatrick, C. M. J., & Green, B. (2012) · Clinical Pharmacokinetics · doi:10.2165/11598930-000000000-00000 · Cited by 162
Model-Based Characterization of the Pharmacokinetics of Pembrolizumab: A Humanized Anti-PD-1 Monoclonal Antibody in Advanced Solid Tumors
Ahamadi, M., Freshwater, T., Prohn, M., Li, C. H., de Alwis, D., de Greef, R., Elassaiss‐Schaap, J., Kondic, A. G., & Stone, J. (2016) · CPT Pharmacometrics & Systems Pharmacology · doi:10.1002/psp4.12139 · Cited by 159
Safety, anti-tumour activity, and pharmacokinetics of fixed-dose SHR-1210, an anti-PD-1 antibody in advanced solid tumours: a dose-escalation, phase 1 study
Mo, H., Huang, J., Xu, J., Chen, X., Wu, D., Qu, D., Wang, X., Lan, B., Wang, X., Xu, J., et al. (2018) · British Journal of Cancer · doi:10.1038/s41416-018-0100-3 · Cited by 153
Lessons for the clinic from rituximab pharmacokinetics and pharmacodynamics
Golay, J., Semenzato, G., Rambaldi, A., Foà, R., Gaidano, G., Gamba, E., Pane, F., Pinto, A., Specchia, G., Zaja, F., et al. (2013) · mAbs · doi:10.4161/mabs.26008 · Cited by 148
Subcutaneous administration of rituximab (MabThera) and trastuzumab (Herceptin) using hyaluronidase
Shpilberg, O., & Jackisch, C. (2013) · British Journal of Cancer · doi:10.1038/bjc.2013.371 · Cited by 138
Clinical pharmacology considerations in biologics development
Zhao, L. Y., Ren, T., & Wang, D. D. (2012) · Acta Pharmacologica Sinica · doi:10.1038/aps.2012.51 · Cited by 132
Self-citation
Clinical pharmacology considerations for the development of immune checkpoint inhibitors
Sheng, J., Srivastava, S., Sanghavi, K., Lu, Z., Schmidt, B. J., Bello, A., & Gupta, M. (2017) · The Journal of Clinical Pharmacology · doi:10.1002/jcph.990 · Cited by 124
Subcutaneous delivery of daratumumab in relapsed or refractory multiple myeloma
Usmani, S. Z., Nahi, H., Mateos, M., van de Donk, N. W. C. J., Chari, A., Kaufman, J. L., Moreau, P., Oriol, A., Plesner, T., Benboubker, L., et al. (2019) · Blood · doi:10.1182/blood.2019000667 · Cited by 120
Pharmacokinetics and safety of subcutaneous rituximab in follicular lymphoma (SABRINA): stage 1 analysis of a randomised phase 3 study
Davies, A., Merli, F., Mihaljevic, B., Siritanaratkul, N., Solal-Céligny, P., Barrett, M., Berge, C., Bittner, B., Boehnke, A., McIntyre, C., et al. (2014) · The Lancet Oncology · doi:10.1016/s1470-2045(14)70005-1 · Cited by 114
Linear pharmacokinetic parameters for monoclonal antibodies are similar within a species and across different pharmacological targets: A comparison between human, cynomolgus monkey and hFcRn Tg32 transgenic mouse using a population-modeling approach
Betts, A. M., Keunecke, A., van Steeg, T. J., van der Graaf, P. H., Avery, L. B., Jones, H. M., & Berkhout, J. (2018) · mAbs · doi:10.1080/19420862.2018.1462429 · Cited by 114
Monoclonal Antibodies: Past, Present and Future
Posner, J., Barrington, P. J., Brier, T., & Datta‐Mannan, A. (2019) · Handbook of experimental pharmacology · doi:10.1007/164_2019_323 · Cited by 120
A Phase IIb Randomized Clinical Study of an Anti-αvβ6 Monoclonal Antibody in Idiopathic Pulmonary Fibrosis
Raghu, G., Mouded, M., Chambers, D. C., Martínez, F. J., Richeldi, L., LANCASTER, L. H., Hamblin, M. J., Gibson, K. F., Rosas, I. O., Prasse, A., et al. (2022) · American Journal of Respiratory and Critical Care Medicine · doi:10.1164/rccm.202112-2824oc · Cited by 102
Understanding Inter-Individual Variability in Monoclonal Antibody Disposition
Thomas, V. A., & Balthasar, J. P. (2019) · Antibodies · doi:10.3390/antib8040056 · Cited by 106
Drug Development of Therapeutic Monoclonal Antibodies
Mould, D. R., & Meibohm, B. (2016) · BioDrugs · doi:10.1007/s40259-016-0181-6 · Cited by 101
Pharmacokinetics, pharmacodynamics and safety of a human anti-IL-6 monoclonal antibody (sirukumab) in healthy subjects in a first-in-human study.
Xu, Z.-H., Bouman-Thio, E., Comisar, C., Frederick, B., van Hartingsveldt, B., Marini, J., Davis, H., & Zhou, H.-H. (2011) · British Journal of Clinical Pharmacology · doi:10.1111/j.1365-2125.2011.03964.x · Cited by 98
Monoclonal antibody and protein therapeutic formulations for subcutaneous delivery: high-concentration, low-volume vs. low-concentration, high-volume
Desai, M. G., Kundu, A., Hageman, M., Lou, H., & Boisvert, D. (2023) · mAbs · doi:10.1080/19420862.2023.2285277 · Cited by 92
Therapeutic drug monitoring of monoclonal antibodies in inflammatory and malignant disease: Translating TNF‐α experience to oncology
Munnink, T. H. O., Henstra, M. J., Segerink, L., Movig, K. L. L., & Brummelhuis-Visser, P. (2015) · Clinical Pharmacology & Therapeutics · doi:10.1002/cpt.211 · Cited by 91
Potential Sources of Inter-Subject Variability in Monoclonal Antibody Pharmacokinetics
Gill, K. L., Machavaram, K. K., Rose, R. H., & Chetty, M. (2016) · Clinical Pharmacokinetics · doi:10.1007/s40262-015-0361-4 · Cited by 82
Time‐Varying Clearance and Impact of Disease State on the Pharmacokinetics of Avelumab in Merkel Cell Carcinoma and Urothelial Carcinoma
Wilkins, J. J., Brockhaus, B., Dai, H. I., Vugmeyster, Y., White, J. T., Brar, S. S., Bello, C. L., Neuteboom, B., Wade, J. R., Girard, P., et al. (2019) · CPT Pharmacometrics & Systems Pharmacology · doi:10.1002/psp4.12406 · Cited by 80
Optimal Dosing Strategy for Fluorescence-Guided Surgery with Panitumumab-IRDye800CW in Head and Neck Cancer
Nishio, N., van den Berg, N. S., van Keulen, S., Martin, B. A., Fakurnejad, S., Zhou, Q., Lu, G., Chirita, S. U., Kaplan, M. J., Divi, V., et al. (2019) · Molecular Imaging and Biology · doi:10.1007/s11307-019-01358-x · Cited by 75
Dose Rationalization of Pembrolizumab and Nivolumab Using Pharmacokinetic Modeling and Simulation and Cost Analysis
Ogungbenro, K., Patel, A., Duncombe, R., Nuttall, R., Clark, J., & Lorigan, P. C. (2017) · Clinical Pharmacology & Therapeutics · doi:10.1002/cpt.875 · Cited by 72
Pharmacokinetic and pharmacodynamic effects of ravulizumab and eculizumab on complement component 5 in adults with paroxysmal nocturnal haemoglobinuria: results of two phase 3 randomised, multicentre studies
de Latour, R. P., Brodsky, R. A., Ortiz, S. R., Risitano, A. M., Jang, J. H., Hillmen, P., Kulagin, A., Kulasekararaj, A. G., Rottinghaus, S. T., Aguzzi, R., et al. (2020) · British Journal of Haematology · doi:10.1111/bjh.16711 · Cited by 70
Evaluation of covariate effects on pharmacokinetics of monoclonal antibodies in oncology
Bajaj, G., Suryawanshi, S., Roy, A., & Gupta, M. (2019) · British Journal of Clinical Pharmacology · doi:10.1111/bcp.13996 · Cited by 68
Obinutuzumab: what is there to learn from clinical trials?
Cartron, G., & Watier, H. (2017) · Blood · doi:10.1182/blood-2017-03-771832 · Cited by 67
Subcutaneous Rituximab for the Treatment of B-Cell Hematologic Malignancies: A Review of the Scientific Rationale and Clinical Development
Davies, A. J., Berge, C., Boehnke, A., Dadabhoy, A., Lugtenburg, P. J., Rule, S. A., Rummel, M., McIntyre, C., Smith, R. B. W., & Badoux, X. C. A. (2017) · Advances in Therapy · doi:10.1007/s12325-017-0610-z · Cited by 67
Exposure–Response Relationship of T-DM1: Insight Into Dose Optimization for Patients With HER2-Positive Metastatic Breast Cancer
Wang, J., Song, P., Schrieber, S. J., Liu, Q., Xu, Q., Blumenthal, G. M., Kordestani, L. A., Cortazar, P., Ibrahim, A., Justice, R. L., et al. (2014) · Clinical Pharmacology & Therapeutics · doi:10.1038/clpt.2014.24 · Cited by 63
Rational development and utilization of antibody-based therapeutic proteins in pediatrics
Xu, Z., Davis, H. M., & Zhou, H. (2012) · Pharmacology & Therapeutics · doi:10.1016/j.pharmthera.2012.10.005 · Cited by 63
Population pharmacokinetic and covariate analysis of pertuzumab, a HER2-targeted monoclonal antibody, and evaluation of a fixed, non-weight-based dose in patients with a variety of solid tumors
Garg, A., Quartino, A. L., Li, J., Jin, J., Wada, D., Li, H., Cortés, J., McNally, V. A., Ross, G. A., Visich, J. E., et al. (2014) · Cancer Chemotherapy and Pharmacology · doi:10.1007/s00280-014-2560-3 · Cited by 62
Population pharmacokinetics of subcutaneous infliximab CT‐P13 in Crohn’s disease and ulcerative colitis
Hanžel, J., Bukkems, L. H., Gecse, K. B., D’Haens, G., & Mathôt, R. A. A. (2021) · Alimentary Pharmacology & Therapeutics · doi:10.1111/apt.16609 · Cited by 58
Reslizumab Compared with Benralizumab in Patients with Eosinophilic Asthma: A Systematic Literature Review and Network Meta-Analysis
Casale, T. B., Pacou, M., Mesana, L., Farge, G., Sun, S. X., & Castro, M. (2018) · The Journal of Allergy and Clinical Immunology In Practice · doi:10.1016/j.jaip.2018.08.036 · Cited by 58
Development of a Subcutaneous Formulation for Trastuzumab - Nonclinical and Clinical Bridging Approach to the Approved Intravenous Dosing Regimen
Bittner, B., Richter, W., Hourcade‐Potelleret, F., McIntyre, C., Herting, F., Zepeda, M. L., & Schmidt, J. (2012) · Arzneimittelforschung · doi:10.1055/s-0032-1321831 · Cited by 57
A model-based meta-analysis of monoclonal antibody pharmacokinetics to guide optimal first-in-human study design
Davda, J. P., Dodds, M., Gibbs, M. A., Wisdom, W., & Gibbs, J. P. (2014) · mAbs · doi:10.4161/mabs.29095 · Cited by 53
A comprehensive review of the pharmacokinetics of approved therapeutic monoclonal antibodies in Japan: Are Japanese phase I studies still needed?
Chiba, K., Yoshitsugu, H., Kyosaka, Y., Iida, S., Yoneyama, K., Tanigawa, T., Fukushima, T., & Hiraoka, M. (2013) · The Journal of Clinical Pharmacology · doi:10.1002/jcph.231 · Cited by 53
Two Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single-Ascending-Dose Studies To Investigate the Safety, Tolerability, and Pharmacokinetics of an Anti-Influenza A Virus Monoclonal Antibody, MHAA4549A, in Healthy Volunteers
Lim, J. J., Deng, R., Derby, M. A., Larouche, R., Horn, P., Anderson, M., Maia, M., Carrier, S., Pelletier, I., Burgess, T., et al. (2016) · Antimicrobial Agents and Chemotherapy · doi:10.1128/aac.00607-16 · Cited by 49
Population pharmacokinetics analysis of VRC01, an HIV-1 broadly neutralizing monoclonal antibody, in healthy adults
Huang, Y., Zhang, L., Ledgerwood, J. E., Grunenberg, N. A., Bailer, R. T., Isaacs, A., Seaton, K. E., Mayer, K. H., Capparelli, E. V., Corey, L., et al. (2017) · mAbs · doi:10.1080/19420862.2017.1311435 · Cited by 49
Antibody–Drug Conjugates as Cancer Therapeutics: Past, Present, and Future
Vezina, H. E., Cotreau, M. M., Han, T. H., & Gupta, M. (2017) · The Journal of Clinical Pharmacology · doi:10.1002/jcph.981 · Cited by 50
Changing Body Weight–Based Dosing to a Flat Dose for Avelumab in Metastatic Merkel Cell and Advanced Urothelial Carcinoma
Novakovic, A. M., Wilkins, J. J., Dai, H. I., Wade, J. R., Neuteboom, B., Brar, S. S., Bello, C. L., Girard, P., & Khandelwal, A. (2019) · Clinical Pharmacology & Therapeutics · doi:10.1002/cpt.1645 · Cited by 45
A Phase I Monotherapy Study of RG7212, a First-in-Class Monoclonal Antibody Targeting TWEAK Signaling in Patients with Advanced Cancers
Lassen, U., Meulendijks, D., Siu, L. L., Karanikas, V., Mau‐Sørensen, M., Schellens, J. H. M., Jonker, D. J., Hansen, A. R., Simcox, M. E., Schostack, K. J., et al. (2014) · Clinical Cancer Research · doi:10.1158/1078-0432.ccr-14-1334 · Cited by 42
Immune checkpoint-targeted antibodies: a room for dose and schedule optimization?
Maritaz, C., Broutin, S., Chaput, N., Marabelle, A., & Paci, A. (2022) · Journal of Hematology & Oncology · doi:10.1186/s13045-021-01182-3 · Cited by 45
Obinutuzumab in the treatment of B-cell malignancies: a comprehensive review
Davies, A. J., Kater, A. P., Sharman, J. P., Stilgenbauer, S., Vitolo, U., Klein, C., Parreira, J. M., & Salles, G. A. (2022) · Future Oncology · doi:10.2217/fon-2022-0112 · Cited by 45
Economics of alternative dosing strategies for pembrolizumab and nivolumab at a single academic cancer center
Hall, E. T., Zhang, J., Kim, E. J., Hwang, G., Chu, G., Bhatia, S., & Reddy, S. A. (2020) · Cancer Medicine · doi:10.1002/cam4.2888 · Cited by 41
Unraveling the complexity of therapeutic drug monitoring for monoclonal antibody therapies to individualize dose in oncology
Chatelut, É., Hendrikx, J. J. M. A., Martin, J. H., Ciccolini, J., & Moes, D. J. A. R. (2021) · Pharmacology Research & Perspectives · doi:10.1002/prp2.757 · Cited by 41
Pharmacokinetics and safety of subcutaneous rituximab plus fludarabine and cyclophosphamide for patients with chronic lymphocytic leukaemia
Assouline, S. E., Buccheri, V., Delmer, A. J., Gaïdano, G., McIntyre, C., Brewster, M., Catalani, O., Hourcade‐Potelleret, F., Sayyed, P. Z., & Badoux, X. C. A. (2015) · British Journal of Clinical Pharmacology · doi:10.1111/bcp.12662 · Cited by 41
Fixed Dosing Versus Body Size—Based Dosing of Therapeutic Peptides and Proteins in Adults
Zhang, S., Shi, R., Li, C., Parivar, K., & Wang, D. D. (2011) · The Journal of Clinical Pharmacology · doi:10.1177/0091270010388648 · Cited by 40
Self-citation
Subcutaneous daratumumab in patients with relapsed or refractory multiple myeloma: Part 2 of the open-label, multicenter, dose-escalation phase 1b study (PAVO)
Miguel, J. F. S., Usmani, S. Z., Mateos, M., van de Donk, N. W. C. J., Kaufman, J. L., Moreau, P., Oriol, A., Plesner, T., Benboubker, L., Liu, K., et al. (2020) · Haematologica · doi:10.3324/haematol.2019.243790 · Cited by 38
Should Clinical Pharmacokinetic Bridging Studies Between Caucasian and Asian Populations Be Required for Approval of Monoclonal Antibodies?
Zhou, H., Tsukamoto, Y., & Davis, H. M. (2011) · The Journal of Clinical Pharmacology · doi:10.1177/0091270011411192 · Cited by 35
Challenges and considerations for development of therapeutic proteins in pediatric patients
Zhang, Y., Wei, X., Bajaj, G., Barrett, J. S., Meibohm, B., Joshi, A., & Gupta, M. (2015) · The Journal of Clinical Pharmacology · doi:10.1002/jcph.382 · Cited by 34
Non-Clinical Pharmacokinetic/Pharmacodynamic and Early Clinical Studies Supporting Development of a Novel Subcutaneous Formulation for the Monoclonal Antibody Rituximab
Bittner, B., Richter, W., Hourcade-Potelleret, F., Herting, F., & Schmidt, J. (2014) · Drug Research · doi:10.1055/s-0033-1363993 · Cited by 32
Pharmacokinetics of MHAA4549A, an Anti-Influenza A Monoclonal Antibody, in Healthy Subjects Challenged with Influenza A Virus in a Phase IIa Randomized Trial
Deng, R., Lee, A. P., Maia, M., Lim, J. J., Burgess, T., Horn, P., Derby, M. A., Newton, E. M., Tavel, J. A., & Hanley, W. D. (2017) · Clinical Pharmacokinetics · doi:10.1007/s40262-017-0564-y · Cited by 30
Mirikizumab Pharmacokinetics in Patients with Moderately to Severely Active Ulcerative Colitis: Results from Phase III LUCENT Studies
Chua, L., Friedrich, S. W., & Zhang, X. C. (2023) · Clinical Pharmacokinetics · doi:10.1007/s40262-023-01281-z · Cited by 29
Use of a Population Pharmacokinetic Approach for the Clinical Development of a Fixed‐Dose Subcutaneous Formulation of Trastuzumab
Hourcade‐Potelleret, F., Lemenuel‐Diot, A., McIntyre, C., Brewster, M., Lum, B., & Bittner, B. (2014) · CPT: Pharmacometrics & Systems Pharmacology · doi:10.1038/psp.2013.63 · Cited by 28
Pharmacokinetic and Pharmacodynamic Modeling of Tezepelumab to Guide Phase 3 Dose Selection for Patients With Severe Asthma
Ly, N. S., Zheng, Y., Griffiths, J. M., van der Merwe, R., Agoram, B. M., Parnes, J. R., & Roskos, L. K. (2020) · The Journal of Clinical Pharmacology · doi:10.1002/jcph.1803 · Cited by 27
Population Pharmacokinetics of Sifalimumab, an Investigational Anti-Interferon-α Monoclonal Antibody, in Systemic Lupus Erythematosus
Narwal, R., Roskos, L. K., & Robbie, G. J. (2013) · Clinical Pharmacokinetics · doi:10.1007/s40262-013-0085-2 · Cited by 27
Challenges and Opportunities With Oncology Drug Development in China
Bajaj, G., Gupta, M., Wang, H. H., Barrett, J. S., Tan, M., Rupalla, K., Bertz, R., & Sheng, J. (2018) · Clinical Pharmacology & Therapeutics · doi:10.1002/cpt.1017 · Cited by 27
Tezepelumab Pharmacokinetics, Safety, and Tolerability After Administration via Vial-and-syringe, Accessorized Prefilled Syringe, or Autoinjector: A Randomized Trial in Healthy Volunteers
Zheng, Y., Abuqayyas, L., Megally, A., Fuhr, R., Sałapa, K., Downie, J., & Colice, G. (2020) · Clinical Therapeutics · doi:10.1016/j.clinthera.2020.11.014 · Cited by 27
Choosing the Allometric Exponent in Covariate Model Building
Sinha, J., Al-Sallami, H. S., & Duffull, S. B. (2018) · Clinical Pharmacokinetics · doi:10.1007/s40262-018-0667-0 · Cited by 27
A first-in-human phase I study of the PD-1 inhibitor, retifanlimab (INCMGA00012), in patients with advanced solid tumors (POD1UM-101)
Lakhani, N. J., Cosman, R., Banerji, U., Rasco, D. W., Tomaszewska‐Kiecana, M., Garralda, E., Kornacki, D., Li, J., Tian, C., Bourayou, N., et al. (2024) · ESMO Open · doi:10.1016/j.esmoop.2024.102254 · Cited by 25
Sabatolimab ( MBG453 ) model‐informed drug development for dose selection in patients with myelodysplastic syndrome/acute myeloid leukemia and solid tumors
Xu, S., Zhang, N., Rinne, M. L., Sun, H., & Stein, A. M. (2023) · CPT Pharmacometrics & Systems Pharmacology · doi:10.1002/psp4.12962 · Cited by 23
Population pharmacokinetic and pharmacodynamic analysis of BIIB023, an anti‐TNF‐like weak inducer of apoptosis (anti‐TWEAK) monoclonal antibody
Galluppi, G. R., Wisniacki, N., & Stebbins, C. (2016) · British Journal of Clinical Pharmacology · doi:10.1111/bcp.12914 · Cited by 23
Phase II Trial of Combined Durvalumab Plus Tremelimumab with Proton Therapy for Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma
Kim, H., Park, S., Jung, H. A., Lee, S., Park, K., Ahn, Y. C., Oh, D., & Ahn, M. (2023) · Cancer Research and Treatment · doi:10.4143/crt.2023.502 · Cited by 22
Fixed dosing of intravenous tocilizumab in rheumatoid arthritis. Results from a population pharmacokinetic analysis
Bastida, C., Ruiz-Esquide, V., Pascal, M., Schultink, A. D. D. V., Yagüe, J., Sanmartí, R., Huitema, A., & Soy, D. (2018) · British Journal of Clinical Pharmacology · doi:10.1111/bcp.13500 · Cited by 21
Model‐Based Assessment of Dosing Strategies in Children for Monoclonal Antibodies Exhibiting Target‐Mediated Drug Disposition
Zheng, S., Gaitonde, P., Andrew, M., Gibbs, M. A., Lesko, L. J., & Schmidt, S. (2014) · CPT Pharmacometrics & Systems Pharmacology · doi:10.1038/psp.2014.38 · Cited by 21
Population pharmacokinetics of tanezumab in phase 3 clinical trials for osteoarthritis pain
Jonsson, E. N., Xie, R., Marshall, S. F., & Arends, R. (2015) · British Journal of Clinical Pharmacology · doi:10.1111/bcp.12850 · Cited by 21
Golimumab Therapy of Rheumatoid Arthritis: An Overview
Zidi, I., Bouaziz, A., Mnif, W., Bartegi, A., Al-Hizab, F. A., & Amor, N. B. (2010) · Scandinavian Journal of Immunology · doi:10.1111/j.1365-3083.2010.02423.x · Cited by 21
Nonclinical safety of mavrilimumab, an anti-GMCSF receptor alpha monoclonal antibody, in cynomolgus monkeys: Relevance for human safety
Ryan, P. C., Sleeman, M. A., Rebelatto, M. C., Wang, B., Lu, H. L., Chen, X., Wu, C., Hinrichs, M. J., Roskos, L. K., Towers, H., et al. (2014) · Toxicology and Applied Pharmacology · doi:10.1016/j.taap.2014.06.002 · Cited by 19
Monoclonal Antibody Monitoring: Clinically Relevant Aspects, A Systematic Critical Review
Regazzi, M. B., Golay, J., & Molinaro, M. (2019) · Therapeutic Drug Monitoring · doi:10.1097/ftd.0000000000000681 · Cited by 19
Exposure‐Response and Population Pharmacokinetic Analyses of a Novel Subcutaneous Formulation of Daratumumab Administered to Multiple Myeloma Patients
Luo, M., Usmani, S. Z., Mateos, M., Nahi, H., Chari, A., Miguel, J. F. S., Touzeau, C., Suzuki, K., Kaiser, M., Carson, R. L., et al. (2020) · The Journal of Clinical Pharmacology · doi:10.1002/jcph.1771 · Cited by 19
Adopting Weight-Based Dosing With Pharmacy-Level Stewardship Strategies Could Reduce Cancer Drug Spending By Millions
Bryant, A. K., Chopra, Z., Edwards, D. M., Whalley, A. S., Bazzell, B. G., Moeller, J. A., Kelley, M. J., Fendrick, A. M., Kerr, E. A., Ramnath, N., et al. (2023) · Health Affairs · doi:10.1377/hlthaff.2023.00102 · Cited by 18
Ranolazine
Keating, G. M. (2013) · Drugs · doi:10.1007/s40265-012-0005-z · Cited by 18
Population pharmacokinetic analysis of sifalimumab from a clinical phase IIb trial in systemic lupus erythematosus patients
Zheng, B., Yu, X., Greth, W., & Robbie, G. J. (2015) · British Journal of Clinical Pharmacology · doi:10.1111/bcp.12864 · Cited by 18
Population Pharmacokinetic Analysis of Bintrafusp Alfa in Different Cancer Types
Wilkins, J. J., Vugmeyster, Y., Dussault, I., Girard, P., & Khandelwal, A. (2019) · Advances in Therapy · doi:10.1007/s12325-019-01018-0 · Cited by 18
An appraisal of subcutaneous trastuzumab: a new formulation meeting clinical needs
Launay‐Vacher, V. (2013) · Cancer Chemotherapy and Pharmacology · doi:10.1007/s00280-013-2289-4 · Cited by 17
Benefit‐risk assessment of nivolumab 240 mg flat dose relative to 3 mg/kg Q2W regimen in Japanese patients with advanced cancers
Bei, D., Osawa, M., Uemura, S., Ohno, T., Gobburu, J. V. S., Roy, A., & Hasegawa, M. (2019) · Cancer Science · doi:10.1111/cas.14252 · Cited by 17
Towards Fixed Dosing of Tocilizumab in ICU-Admitted COVID-19 Patients: Results of an Observational Population Pharmacokinetic and Descriptive Pharmacodynamic Study
Moes, D. J. A. R., van Westerloo, D. J., Arend, S. M., Swen, J. J., de Vries, A., Guchelaar, H., Joosten, S. A., de Boer, M. G. J., van Gelder, T., & van Paassen, J. (2021) · Clinical Pharmacokinetics · doi:10.1007/s40262-021-01074-2 · Cited by 18
Issues, challenges, and opportunities in model-based drug development for monoclonal antibodies
Hu, L., & Hansen, R. J. (2013) · Journal of Pharmaceutical Sciences · doi:10.1002/jps.23504 · Cited by 16
Effect of correlation on covariate selection in linear and nonlinear mixed effect models
Bonate, P. L. (2016) · Pharmaceutical Statistics · doi:10.1002/pst.1776 · Cited by 15
Platform model describing pharmacokinetic properties of vc-MMAE antibody–drug conjugates
Kågedal, M., Gibiansky, L. V., Xu, J. M., Wang, X., Samineni, D., Chen, S., Lu, D., Agarwal, P., Wang, B., Saad, O. M., et al. (2017) · Journal of Pharmacokinetics and Pharmacodynamics · doi:10.1007/s10928-017-9544-y · Cited by 15
Tanezumab: a selective humanized mAb for chronic lower back pain
Webb, M., Helander, E. M., Menard, B. L., Urman, R. D., & Kaye, A. D. (2018) · Therapeutics and Clinical Risk Management · doi:10.2147/tcrm.s144125 · Cited by 15
A cost analysis study of the implementation of fixed-dosing of monoclonal antibodies in the Netherlands Cancer Institute
Heinhuis, K. M., Barkman, H. J., Beijnen, J. H., & Hendrikx, J. J. M. A. (2020) · International Journal of Clinical Pharmacy · doi:10.1007/s11096-020-01131-z · Cited by 14
Clinical Pharmacology Tools and Evaluations to Facilitate Comprehensive Dose Finding in Oncology: A Continuous Risk‐Benefit Approach
Bullock, J. M., Lin, T., & Bilic, S. (2017) · The Journal of Clinical Pharmacology · doi:10.1002/jcph.908 · Cited by 14
Fixed Dose of Cemiplimab in Patients with Advanced Malignancies Based on Population Pharmacokinetic Analysis
Paccaly, A. J., Migden, M. R., Papadopoulos, K. P., Yang, F., Davis, J. D., Rippley, R. K., Lowy, I., Fury, M. G., Stankevich, E., & Rischin, D. (2021) · Advances in Therapy · doi:10.1007/s12325-021-01638-5 · Cited by 14
Mim8 Bispecific Antibody Prophylaxis in Hemophilia A with or without Inhibitors
Mancuso, M. E., Chan, A. K. C., Shanmukhaiah, C., Lyu, C. J., Zdziarska, J., Mahlangu, J. N., van Vulpen, L. F. D., Chowdary, P., Yang, R., Lentz, S. R., et al. (2026) · New England Journal of Medicine · doi:10.1056/nejmoa2517384 · Cited by 13
Incorporation of FcRn‐mediated disposition model to describe the population pharmacokinetics of therapeutic monoclonal IgG antibody in clinical patients
Ng, C. M. (2015) · Biopharmaceutics & Drug Disposition · doi:10.1002/bdd.1997 · Cited by 13
Donanemab exposure‐response in early symptomatic Alzheimer's disease
Gueorguieva, I., Chow, K. H., Chua, L., Shcherbinin, S., Zimmer, J. A., Evans, C. D., Wang, H., Nery, E. S. M., Brooks, D. A., & Sims, J. R. (2025) · Alzheimer s & Dementia · doi:10.1002/alz.70491 · Cited by 13
Optimization of radotinib doses for the treatment of Asian patients with chronic myelogenous leukemia based on dose-response relationship analyses
Noh, H., Park, M. S., Kim, S., Oh, S. J., Zang, D. Y., Park, H. L., Cho, D. J., Kim, D.-W., & Lee, J. I. (2015) · Leukemia & lymphoma/Leukemia and lymphoma · doi:10.3109/10428194.2015.1113278 · Cited by 13
Subcutaneous Rituximab with Recombinant Human Hyaluronidase in the Treatment of Non-Hodgkin Lymphoma and Chronic Lymphocytic Leukemia
Hill, S. L., & Davies, A. J. (2018) · Future Oncology · doi:10.2217/fon-2017-0574 · Cited by 12
Anti-MAdCAM-1 antibody (PF-00547659) for active refractory Crohn’s disease in Japanese and Korean patients: the OPERA study
Saruta, M., Park, D. I., Kim, Y., Yang, S., Jang, B. I., Cheon, J. H., Im, J. P., Kanai∥, T., Katsuno, T., Ishiguro, Y., et al. (2020) · Intestinal Research · doi:10.5217/ir.2019.00039 · Cited by 12
Model Informed Dosing Regimen and Phase I Results of the Anti‐PD‐1 Antibody Budigalimab (ABBV‐181)
Powderly, J. D., Spira, A. I., Kondo, S., Doi, T., Luke, J. J., Rasco, D. W., Gao, B., Tanner, M., Cassier, P. A., Gazzah, A., et al. (2020) · Clinical and Translational Science · doi:10.1111/cts.12855 · Cited by 13
Subcutaneous drug delivery devices—Enablers of a flexible care setting
Bittner, B., & Schmidt, J. (2020) · Elsevier eBooks · doi:10.1016/b978-0-12-819838-4.00021-3 · Cited by 12

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

About these checks

Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.

Statistics and arithmetic are recomputed, not judged.

Confidence bands are shown only for fields calibrated on our annotated test set. None is calibrated yet, so no band is shown.

What counts as a claim ›How we measure confidence ›How we check this ›

Are you an author, or do you see a problem with this page? Request a review

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

Abstract

Overview

Integrity signals

Verification

Claims the paper makes

Claims other papers make about this one

Citations

Cites

Cited by

Related

Metadata

Record

About these checks