Cited by 82Monoclonal and Polyclonal Antibodies ResearchBiosimilars and Bioanalytical MethodsPharmaceutical studies and practices

The DOI matches its Crossref record; 211 of the 211 references it cites were found in a registry or an index.

Potential Sources of Inter-Subject Variability in Monoclonal Antibody Pharmacokinetics

Gill, Katherine L., Machavaram, Krishna K., Rose, Rachel H., Chetty, Manoranjenni·2016·Clinical Pharmacokinetics

DOI 10.1007/s40262-015-0361-4

Open this paper in CoChat — free account

Abstract

Understanding inter-subject variability in drug pharmacokinetics and pharmacodynamics is important to ensure that all patients attain suitable drug exposure to achieve efficacy and avoid toxicity. Inter-subject variability in the pharmacokinetics of therapeutic monoclonal antibodies (mAbs) is generally moderate to high; however, the factors responsible for the high inter-subject variability have not been comprehensively reviewed. In this review, the extent of inter-subject variability for mAb pharmacokinetics is presented and potential factors contributing to this variability are explored and summarised. Disease status, age, sex, ethnicity, body size, genetic polymorphisms, concomitant medication, co-morbidities, immune status and multiple other patient-specific details have been considered. The inter-subject variability for mAb pharmacokinetics most likely depends on the complex interplay of multiple factors. However, studies aimed at investigating the reasons for the inter-subject variability are sparse. Population pharmacokinetic models and physiologically based pharmacokinetic models are useful tools to identify important covariates, aiding in the understanding of factors contributing to inter-subject variability. Further understanding of inter-subject variability in pharmacokinetics should aid in development of dosing regimens that are more appropriate.

Integrity signals

Registry

Crossref · 10.1007/s40262-015-0361-4

Cites

211 of 211 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?

Phase II study of weekly intravenous recombinant humanized anti-p185HER2 monoclonal antibody in patients with HER2/neu-overexpressing metastatic breast cancer.
Baselga, J. M., Tripathy, D., Mendelsohn, J. M., Baughman, S. A., Benz, C. C., Dantis, L., Sklarin, N. T., Seidman, A. D., Hudis, C. A., Moore, J. L., et al. (1996) · Journal of Clinical Oncology · doi:10.1200/jco.1996.14.3.737 · Cited by 1,382
Effects of protein aggregates: An immunologic perspective
Rosenberg, A. S. (2006) · The AAPS Journal · doi:10.1208/aapsj080359 · Cited by 1,355
Body composition of reference children from birth to age 10 years
Fomon, S. J., Haschke, F., Ziegler, E., & Nelson, S. (1982) · American Journal of Clinical Nutrition · doi:10.1093/ajcn/35.5.1169 · Cited by 1,264
Phase II study of receptor-enhanced chemosensitivity using recombinant humanized anti-p185HER2/neu monoclonal antibody plus cisplatin in patients with HER2/neu-overexpressing metastatic breast cancer refractory to chemotherapy treatment.
Pegram, M. D., Lipton, A., Hayes, D. F., Weber, B. L., Baselga, J. M., Tripathy, D., Baly, D. L., Baughman, S. A., Twaddell, T., Glaspy, J. A., et al. (1998) · Journal of Clinical Oncology · doi:10.1200/jco.1998.16.8.2659 · Cited by 1,066
Monoclonal Antibody Pharmacokinetics and Pharmacodynamics
Wang, W., Wang, E., & Balthasar, J. (2008) · Clinical Pharmacology & Therapeutics · doi:10.1038/clpt.2008.170 · Cited by 978
Phase I Studies of Anti–Epidermal Growth Factor Receptor Chimeric Antibody C225 Alone and in Combination With Cisplatin
Baselga, J. M., Pfister, D. G., Cooper, M. R., Cohen, R. B., Burtness, B. A., Bos, M. M. E. M., D’Andrea, G. M., Seidman, A. D., Norton, L., Gunnett, K., et al. (2000) · Journal of Clinical Oncology · doi:10.1200/jco.2000.18.4.904 · Cited by 741
The physiology of the lymphatic system
Swartz, M. A. (2001) · Advanced Drug Delivery Reviews · doi:10.1016/s0169-409x(01)00150-8 · Cited by 738
Metabolism of Immunoglobulins
Waldmann, T. A., & Strober, W. (2015) · Chemical immunology/Fortschritte der Allergielehre/Progress in allergy/Chemical immunology and allergy · doi:10.1159/000385919 · Cited by 731
Clinical Pharmacokinetics of Therapeutic Monoclonal Antibodies
Keizer, R. J., Huitema, A. D. R., Schellens, J. H. M., & Beijnen, J. H. (2010) · Clinical Pharmacokinetics · doi:10.2165/11531280-000000000-00000 · Cited by 725
Transport of Molecules, Particles, and Cells in Solid Tumors
Jain, R. K. (1999) · Annual Review of Biomedical Engineering · doi:10.1146/annurev.bioeng.1.1.241 · Cited by 701
Immunogenicity of therapeutic proteins: Influence of aggregation
Ratanji, K. D., Derrick, J. P., Dearman, R. J., & Kimber, I. (2013) · Journal of Immunotoxicology · doi:10.3109/1547691x.2013.821564 · Cited by 610
Physiologic upper limits of pore size of different blood capillary types and another perspective on the dual pore theory of microvascular permeability
Sarin, H. (2010) · Vascular Cell · doi:10.1186/2040-2384-2-14 · Cited by 573
The Simcyp ® Population-based ADME Simulator
Jamei, M., Marciniak, S., Feng, K., Barnett, A., Tucker, G., & Rostami-Hodjegan, A. (2009) · Expert Opinion on Drug Metabolism & Toxicology · doi:10.1517/17425250802691074 · Cited by 533
Linkage of chondrocyte apoptosis and cartilage degradation in human osteoarthritis
Hashimoto, S., Ochs, R., Komiya, S., & Lotz, M. (1998) · Arthritis & Rheumatism · doi:10.1002/1529-0131(199809)41:9 · Cited by 500
Population Pharmacokinetics of Therapeutic Monoclonal Antibodies
Dirks, N. L., & Meibohm, B. (2010) · Clinical Pharmacokinetics · doi:10.2165/11535960-000000000-00000 · Cited by 500
Elimination mechanisms of therapeutic monoclonal antibodies
Tabrizi, M. A., Tseng, C.-M. L., & Roskos, L. K. (2006) · Drug Discovery Today · doi:10.1016/s1359-6446(05)03638-x · Cited by 479
Rituximab-Dependent Cytotoxicity by Natural Killer Cells
Dall’Ozzo, S., Tartas, S., Paintaud, G., Cartron, G., Colombat, P., Bardos, P., Watier, H., & Thibault, G. (2004) · Cancer Research · doi:10.1158/0008-5472.can-03-2862 · Cited by 434
Towards a platform PBPK model to characterize the plasma and tissue disposition of monoclonal antibodies in preclinical species and human
Shah, D. K., & Betts, A. M. (2011) · Journal of Pharmacokinetics and Pharmacodynamics · doi:10.1007/s10928-011-9232-2 · Cited by 431
The relationship of serum infliximab concentrations to clinical improvement in rheumatoid arthritis: Results from ATTRACT, a multicenter, randomized, double‐blind, placebo‐controlled trial
Clair, E. W. S., Wagner, C. L., Fasanmade, A. A., Wang, B., Schaible, T. F., Kavanaugh, A., & Keystone, E. C. (2002) · Arthritis & Rheumatism · doi:10.1002/art.10302 · Cited by 416
Individualized monitoring of drug bioavailability and immunogenicity in rheumatoid arthritis patients treated with the tumor necrosis factor α inhibitor infliximab
Bendtzen, K., Geborek, P., Svenson, M., Larsson, L., Kapetanovic, M. C., & Saxne, T. (2006) · Arthritis & Rheumatism · doi:10.1002/art.22214 · Cited by 388
Inflammation- and ischemia-induced shedding of venular glycocalyx
Mulivor, A. W., & Lipowsky, H. H. (2004) · American Journal of Physiology-Heart and Circulatory Physiology · doi:10.1152/ajpheart.00832.2003 · Cited by 382
Mechanistic Determinants of Biotherapeutics Absorption Following SC Administration
Richter, W. F., Bhansali, S. G., & Morris, M. E. (2012) · The AAPS Journal · doi:10.1208/s12248-012-9367-0 · Cited by 377
A Framework for Assessing Inter-individual Variability in Pharmacokinetics Using Virtual Human Populations and Integrating General Knowledge of Physical Chemistry, Biology, Anatomy, Physiology and Genetics: A Tale of ‘Bottom-Up’ vs ‘Top-Down’ Recognition of Covariates
Jamei, M., Dickinson, G. L., & Rostami‐Hodjegan, A. (2009) · Drug Metabolism and Pharmacokinetics · doi:10.2133/dmpk.24.53 · Cited by 377
Ontogeny of early life immunity
Dowling, D. J., & Levy, O. (2014) · Trends in Immunology · doi:10.1016/j.it.2014.04.007 · Cited by 376
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
Immunogenicity to Therapeutic Proteins: Impact on PK/PD and Efficacy
Chirmule, N. B., Jawa, V., & Meibohm, B. (2012) · The AAPS Journal · doi:10.1208/s12248-012-9340-y · Cited by 338
Factors influencing the immunogenicity of therapeutic proteins
Schellekens, H. (2005) · Nephrology Dialysis Transplantation · doi:10.1093/ndt/gfh1092 · Cited by 332
Physiologically-based pharmacokinetic (PBPK) model to predict IgG tissue kinetics in wild-type and FcRn-knockout mice
Garg, A., & Balthasar, J. P. (2007) · Journal of Pharmacokinetics and Pharmacodynamics · doi:10.1007/s10928-007-9065-1 · Cited by 329
Population pharmacokinetic analysis of infliximab in patients with ulcerative colitis
Fasanmade, A. A., Adedokun, O. J., Ford, J. A., Hernandez, D., Johanns, J., Hu, C., Davis, H. M., & Zhou, H. (2009) · European Journal of Clinical Pharmacology · doi:10.1007/s00228-009-0718-4 · Cited by 328
Expression of the neonatal Fc receptor, FcRn, on human intestinal epithelial cells
Israel, E. J., TAYLOR, S., WU, Z., Mizoguchi, E., Blumberg, R. S., Bhan, A. K., & Simister, N. E. (1997) · Immunology · doi:10.1046/j.1365-2567.1997.00326.x · Cited by 328
Pharmacokinetics of monoclonal immunoglobulin G1, F(ab')2, and Fab' in mice.
Covell, D. G., Barbet, J., Holton, O. D., BLACK, C. D. V., Parker, R. J., & Weinstein, J. N. (1986) · PubMed · Cited by 311
Safety and Efficacy of Adalimumab for Moderate to Severe Crohn's Disease in Children
Hyams, J. S., Griffiths, A. M., Markowitz, J. F., Baldassano, R. N., Faubion, W. A., Colletti, R. B., Dubinsky, M. C., Kierkuś, J., Rosh, J. R., Wang, Y., et al. (2012) · Gastroenterology · doi:10.1053/j.gastro.2012.04.046 · Cited by 310
Biodistribution Mechanisms of Therapeutic Monoclonal Antibodies in Health and Disease
Tabrizi, M. A., Bornstein, G. G., & Suria, H. (2009) · The AAPS Journal · doi:10.1208/s12248-009-9157-5 · Cited by 307
Efficacy, pharmacokinetic, and safety assessment of adalimumab, a fully human anti-tumor necrosis factor-alpha monoclonal antibody, in adults with rheumatoid arthritis receiving concomitant methotrexate: A pilot study
Weisman, M. H., Moreland, L. W., Furst, D. E., Weinblatt, M. E., Keystone, E. C., Paulus, H. E., Teoh, L. S., Velagapudi, R. B., Noertersheuser, P. A., Granneman, G. R., et al. (2003) · Clinical Therapeutics · doi:10.1016/s0149-2918(03)80164-9 · Cited by 303
Untitled work
(2000) · PubMed · Cited by 295
Physiologically based pharmacokinetic model for specific and nonspecific monoclonal antibodies and fragments in normal tissues and human tumor xenografts in nude mice.
Baxter, L. T., Zhu, H. J., Mackensen, D. G., & Jain, R. K. (1994) · PubMed · Cited by 280
Pharmacokinetics and toxicology of therapeutic proteins: Advances and challenges
Vugmeyster, Y. (2012) · World Journal of Biological Chemistry · doi:10.4331/wjbc.v3.i4.73 · Cited by 252
Disease–Drug–Drug Interaction Involving Tocilizumab and Simvastatin in Patients With Rheumatoid Arthritis
Schmitt, C., Kuhn, B., Zhang, X.-P., Kivitz, A., & Grange, S. (2011) · Clinical pharmacology and therapy · doi:10.1038/clpt.2011.35 · Cited by 249
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
A randomised, double-blind, parallel-group study of the safety and efficacy of subcutaneous tocilizumab versus intravenous tocilizumab in combination with traditional disease-modifying antirheumatic drugs in patients with moderate to severe rheumatoid arthritis (SUMMACTA study)
Burmester, G., Rubbert-Roth, A., Cantagrel, A., Hall, S., Leszczyński, P., Feldman, D., Rangaraj, M. J., Roane, G., Ludivico, C., Lu, P., et al. (2013) · Annals of the Rheumatic Diseases · doi:10.1136/annrheumdis-2013-203523 · Cited by 243
Pharmacokinetics, Pharmacodynamics and Physiologically-Based Pharmacokinetic Modelling of Monoclonal Antibodies
Dostálek, M., Gardner, I. B., Gurbaxani, B. M., Rose, R. H., & Chetty, M. (2013) · Clinical Pharmacokinetics · doi:10.1007/s40262-012-0027-4 · Cited by 236
Self-citation
Protein Ectodomain Shedding
Arribas, J., & Borroto, A. (2002) · Chemical Reviews · doi:10.1021/cr010202t · Cited by 236
Safety, tolerance and pharmacokinetics of a humanized monoclonal antibody to respiratory syncytial virus in premature infants and infants with bronchopulmonary dysplasia
Subramanian, K. N. S., WEISMAN, L. E., RHODES, T., Ariagno, R. L., Sánchez, P. J., Steichen, J. J., Givner, L. B., JENNINGS, T. L., Top, F. H., Carlin, D. A., et al. (1998) · The Pediatric Infectious Disease Journal · doi:10.1097/00006454-199802000-00006 · Cited by 226
Anti-infliximab and anti-adalimumab antibodies in relation to response to adalimumab in infliximab switchers and anti-tumour necrosis factor naive patients: a cohort study
Bartelds, G. M., Wijbrandts, C. A., Nurmohamed, M. T., Stapel, S. O., Lems, W. F., Aarden, L. A., Dijkmans, B. A. C., Tak, P. P., & Wolbink, G. (2009) · Annals of the Rheumatic Diseases · doi:10.1136/ard.2009.112847 · Cited by 226
Perspective – FcRn transports albumin: relevance to immunology and medicine
Anderson, C. L., Chaudhury, C., Kim, J., Bronson, C. L., Wani, M. A., & Mohanty, S. (2006) · Trends in Immunology · doi:10.1016/j.it.2006.05.004 · Cited by 216
Relationship between serum trough infliximab levels, pretreatment C reactive protein levels, and clinical response to infliximab treatment in patients with rheumatoid arthritis
Wolbink, G., Voskuyl, A. E., Lems, W. F., de Groot, E. R., Nurmohamed, M. T., Tak, P. P., Dijkmans, B. A. C., & Aarden, L. A. (2004) · Annals of the Rheumatic Diseases · doi:10.1136/ard.2004.030452 · Cited by 215
Kinetics of FcRn-mediated recycling of IgG and albumin in human: Pathophysiology and therapeutic implications using a simplified mechanism-based model
Kim, J., Hayton, W. L., Robinson, J. M., & Anderson, C. L. (2007) · Clinical Immunology · doi:10.1016/j.clim.2006.09.001 · Cited by 208
Circulating CD20 is detectable in the plasma of patients with chronic lymphocytic leukemia and is of prognostic significance
Manshouri, T., Do, K.-A., Wang, X., Giles, F. J., O'Brien, S. M., Saffer, H. L., Thomas, D. A., Jilani, I. B., Kantarjian, H. M., Keating, M. J., et al. (2003) · Blood · doi:10.1182/blood-2002-06-1639 · Cited by 208
Pharmacokinetics and Pharmacodynamics of Monoclonal Antibodies
Mould, D. R., & Green, B. (2010) · BioDrugs · doi:10.2165/11530560-000000000-00000 · Cited by 207
Population Pharmacokinetics of Rituximab (Anti‐CD20 Monoclonal Antibody) in Rheumatoid Arthritis Patients During a Phase II Clinical Trial
Ng, C. M., Bruno, R., Combs, D., & Davies, B. (2005) · The Journal of Clinical Pharmacology · doi:10.1177/0091270005277075 · Cited by 203
Applications of minimal physiologically-based pharmacokinetic models
Cao, Y.-G., & Jusko, W. (2012) · Journal of Pharmacokinetics and Pharmacodynamics · doi:10.1007/s10928-012-9280-2 · Cited by 200
Effect of Smoking and Sun on the Aging Skin
Kennedy, C., Bastiaens, M. T., Willemze, R., Bouwes Bavinck, J. N., Bajdik, C. D., & Westendorp, R. G. J. (2003) · Journal of Investigative Dermatology · doi:10.1046/j.1523-1747.2003.12092.x · Cited by 196
A single dose, placebo controlled study of the fully human anti-tumor necrosis factor-alpha antibody adalimumab (D2E7) in patients with rheumatoid arthritis.
den Broeder, A. A., van de Putte, L., Rau, R., Schattenkirchner, M., van Riel, P. L. C. M., Sander, O., Binder, C., Fenner, H., Bankmann, Y., Velagapudi, R. B., et al. (2002) · PubMed · Cited by 195
Pharmacokinetics of alemtuzumab used for in vivo and in vitro T-cell depletion in allogeneic transplantations: relevance for early adoptive immunotherapy and infectious complications
Morris, E. C., Rebello, P., Thomson, K. J., Peggs, K. S., Kyriakou, C. A., Goldstone, A. H., Mackinnon, S., & Hale, G. (2003) · Blood · doi:10.1182/blood-2002-09-2687 · Cited by 194
Population pharmacokinetic studies in pediatrics: Issues in design and analysis
Meibohm, B., Läer, S., Panetta, J. C., & Barrett, J. S. (2005) · The AAPS Journal · doi:10.1208/aapsj070248 · Cited by 193
Phase 1 Evaluation of the Respiratory Syncytial Virus–Specific Monoclonal Antibody Palivizumab in Recipients of Hematopoietic Stem Cell Transplants
Boeckh, M., Berrey, M. M., Bowden, R. A., Crawford, S. W., Balsley, J., & Corey, L. (2001) · The Journal of Infectious Diseases · doi:10.1086/322043 · Cited by 192
Fixed Dosing Versus Body Size—Based Dosing of Monoclonal Antibodies in Adult Clinical Trials
Wang, D. D., Zhang, S., Zhao, H., Men, A. Y., & Parivar, K. (2009) · The Journal of Clinical Pharmacology · doi:10.1177/0091270009337512 · Cited by 192
Inadequately low serum levels of steroid hormones in relation to interleukin‐6 and tumor necrosis factor in untreated patients with early rheumatoid arthritis and reactive arthritis
Straub, R. H., Paimela, L., Peltomaa, R., Schölmerich, J., & Leirisalo‐Repo, M. (2002) · Arthritis & Rheumatism · doi:10.1002/art.10177 · Cited by 183
Biodistribution of monoclonal antibodies: scale-up from mouse to human using a physiologically based pharmacokinetic model.
Baxter, L. T., Zhu, H. J., Mackensen, D. G., Butler, W. F., & Jain, R. K. (1995) · PubMed · Cited by 179
Population Pharmacokinetic Modeling of Ustekinumab, a Human Monoclonal Antibody Targeting IL‐12/23p40, in Patients With Moderate to Severe Plaque Psoriasis
Zhu, Y., Hu, C., Lu, M., Liao, S., Marini, J. C., Yohrling, J., Yeilding, N. M., Davis, H. M., & Zhou, H. (2009) · The Journal of Clinical Pharmacology · doi:10.1177/0091270008329556 · Cited by 175
A mechanism‐based binding model for the population pharmacokinetics and pharmacodynamics of omalizumab
Hayashi, N., Tsukamoto, Y., Sallas, W. M., & Lowe, P. J. (2006) · British Journal of Clinical Pharmacology · doi:10.1111/j.1365-2125.2006.02803.x · Cited by 173
Accelerated breakdown of immunoglobulin G (IgG) in myotonic dystrophy: a hereditary error of immunoglobulin catabolism.
Wochner, R. D., Drews, G., Strober, W., & Waldmann, T. A. (1966) · Journal of Clinical Investigation · doi:10.1172/jci105346 · Cited by 169
Second-generation minimal physiologically-based pharmacokinetic model for monoclonal antibodies
Cao, Y., Balthasar, J. P., & Jusko, W. J. (2013) · Journal of Pharmacokinetics and Pharmacodynamics · doi:10.1007/s10928-013-9332-2 · Cited by 161
A Phase 1 Escalating Single-Dose and Weekly Fixed-Dose Study of Cetuximab: Pharmacokinetic and Pharmacodynamic Rationale for Dosing
Fracasso, P. M., Burris, H. A., Arquette, M. A., Govindan, R., Gao, F., Wright, L. P., Goodner, S. A., Greco, F. A., Jones, S. F., Willcutt, N. T., et al. (2007) · Clinical Cancer Research · doi:10.1158/1078-0432.ccr-06-1542 · Cited by 153
Baseline tumour necrosis factor alpha levels predict the necessity for dose escalation of infliximab therapy in patients with rheumatoid arthritis
Takeuchi, T., Miyasaka, N., Tatsuki, Y., Yano, T., Yoshinari, T., Abe, T., & Koike, T. (2011) · Annals of the Rheumatic Diseases · doi:10.1136/ard.2011.153023 · Cited by 151
Pharmacokinetic and pharmacodynamic considerations in the development of therapeutic proteins
Mahmood, I., & Green, M. D. (2005) · Clinical Pharmacokinetics · doi:10.2165/00003088-200544040-00001 · Cited by 150
Population Pharmacokinetics of Palivizumab, a Humanized Anti-Respiratory Syncytial Virus Monoclonal Antibody, in Adults and Children
Robbie, G. J., Zhao, L., Mondick, J. T., Losonsky, G. A., & Roskos, L. K. (2012) · Antimicrobial Agents and Chemotherapy · doi:10.1128/aac.06446-11 · Cited by 150
Extent and Clinical Consequences of Antibody Formation Against Adalimumab in Patients With Plaque Psoriasis
Lecluse, L. L. A., Driessen, R. J. B., Spuls, P. I., de Jong, E. M. G. J., Stapel, S. O., van Doorn, M. B. A., Bos, J. D., & Wolbink, G. (2010) · Archives of Dermatology · doi:10.1001/archdermatol.2009.347 · Cited by 148
Familial hypercatabolic hypoproteinemia caused by deficiency of the neonatal Fc receptor, FcRn, due to a mutant β 2 -microglobulin gene
Wani, M. A., Haynes, L. D., Kim, J., Bronson, C. L., Chaudhury, C., Mohanty, S., Waldmann, T. A., Robinson, J. M., & Anderson, C. L. (2006) · Proceedings of the National Academy of Sciences · doi:10.1073/pnas.0600548103 · Cited by 147
Clinical and experimental metabolism of normal 6.6s gamma-globulin in normal subjects and in patients with macroglobulinemia and multiple myeloma.
Solomon, A., Waldmann, T. A., & Fahey, J. L. (1963) · PubMed · Cited by 147
Human lymph node morphology as a function of age and site.
Luscieti, P., Hubschmid, T., Cottier, H., Hess, M. W., & Sobin, L. H. (1980) · Journal of Clinical Pathology · doi:10.1136/jcp.33.5.454 · Cited by 145
A Predictive Model of Therapeutic Monoclonal Antibody Dynamics and Regulation by the Neonatal Fc Receptor (FcRn)
Ferl, G. Z., Wu, A. M., & DiStefano, J. J. (2005) · Annals of Biomedical Engineering · doi:10.1007/s10439-005-7410-3 · Cited by 144
Anaphylactoid reactions in two patients after omalizumab administration after successful long-term therapy
Price, K. S., & Hamilton, R. G. (2007) · Allergy and Asthma Proceedings · doi:10.2500/aap.2007.28.3003 · Cited by 143
Characterizing the Impact of Renal Impairment on the Clinical Pharmacology of Biologics
Meibohm, B., & Zhou, H. (2012) · The Journal of Clinical Pharmacology · doi:10.1177/0091270011413894 · Cited by 142
Phase III Study of the Efficacy and Safety of Subcutaneous Versus Intravenous Tocilizumab Monotherapy in Patients With Rheumatoid Arthritis
Ogata, A., Tanimura, K., Sugimoto, T., Inoue, H., Urata, Y., Matsubara, T., Kondo, M., Ueki, Y., Iwahashi, M., Tohma, S., et al. (2014) · Arthritis Care & Research · doi:10.1002/acr.22110 · Cited by 140
Metabolic heterogeneity of human γ-globulin
Cohen, S., & FREEMAN, T. (1960) · Biochemical Journal · doi:10.1042/bj0760475 · Cited by 136
Population Pharmacokinetics and Pharmacodynamics of the Anti-CD11a Antibody hu1124 in Human Subjects with Psoriasis
Bauer, R. J., Dedrick, R. L., White, M., Murray, M. J., & Garovoy, M. R. (1999) · Journal of Pharmacokinetics and Biopharmaceutics · doi:10.1023/a:1020917122093 · Cited by 135
DISPOSITION OF BASILIXIMAB, AN INTERLEUKIN-2 RECEPTOR MONOCLONAL ANTIBODY, IN RECIPIENTS OF MISMATCHED CADAVER RENAL ALLOGRAFTS1
Kovarik, J. M., Wolf, P., Cisterne, J. M., Mourad, G., Lebranchu, Y., Lang, P., Bourbigot, B., Cantarovich, D., Girault, D., Gerbeau, C., et al. (1997) · Transplantation · doi:10.1097/00007890-199712270-00012 · Cited by 130
Fcγ receptor type IIIA polymorphisms influence treatment outcomes in patients with inflammatory arthritis treated with tumor necrosis factor α–blocking agents
Tutuncu, Z. N., Kavanaugh, A., Zvaifler, N. J., Corr, M., Deutsch, R., & Boyle, D. (2005) · Arthritis & Rheumatism · doi:10.1002/art.21266 · Cited by 130
A safety and pharmacokinetic study of intravenous natalizumab in patients with MS
Sheremata, W. A., Vollmer, T. R., Stone, L. A., Willmer–Hulme, A., & Köller, M. (1999) · Neurology · doi:10.1212/wnl.52.5.1072 · Cited by 128
The Antibody Drug Absorption Following Subcutaneous or Intramuscular Administration and Its Mathematical Description by Coupling Physiologically Based Absorption Process with the Conventional Compartment Pharmacokinetic Model
Zhao, L. Y., Ji, P., Li, Z., Roy, P., & Sahajwalla, C. G. (2013) · The Journal of Clinical Pharmacology · doi:10.1002/jcph.4 · Cited by 127
The Versatile MHC Class I-related FcRn Protects IgG and Albumin from Degradation: Implications for Development of New Diagnostics and Therapeutics
Andersen, J. T., & Sandlie, I. (2009) · Drug Metabolism and Pharmacokinetics · doi:10.2133/dmpk.24.318 · Cited by 124
Distribution of the IgG Fc Receptor, FcRn, in the Human Fetal Intestine
Shah, U. S., Dickinson, B. L., Blumberg, R. S., Simister, N. E., Lencer, W. I., & Walker, W. A. (2003) · Pediatric Research · doi:10.1203/01.pdr.0000047663.81816.e3 · Cited by 120
Clinical Relevance of Fcγ Receptor Polymorphisms
Rascu, A., Repp, R., WESTERDAAL, N. A. C., Kalden, J. R., & van de Winkel, J. G. J. (1997) · Annals of the New York Academy of Sciences · doi:10.1111/j.1749-6632.1997.tb52070.x · Cited by 119
Population Pharmacokinetic Analysis of Tocilizumab in Patients With Rheumatoid Arthritis
Frey, N., Grange, S., & Woodworth, T. (2010) · Journal of clinical pharmacology · doi:10.1177/0091270009350623 · Cited by 116
Population pharmacokinetics–pharmacodynamics of alemtuzumab (Campath ® ) in patients with chronic lymphocytic leukaemia and its link to treatment response
Mould, D. R., Baumann, A., Kuhlmann, J., Keating, M. J., Weitman, S., Hillmen, P., Brettman, L. R., Reif, S., & Bonate, P. L. (2007) · British Journal of Clinical Pharmacology · doi:10.1111/j.1365-2125.2007.02914.x · Cited by 116
Lymph flow dynamics in exercising human skeletal muscle as detected by scintography
Havas, E., Parviainen, T., Vuorela, J., Toivanen, J., Nikula, T. K., & Vihko, V. (1997) · The Journal of Physiology · doi:10.1111/j.1469-7793.1997.233bf.x · Cited by 114
Dose escalation and pharmacokinetic study of a humanized anti-HER2 monoclonal antibody in patients with HER2/neu-overexpressing metastatic breast cancer
Tokuda, Y., Watanabe, T., Omuro, Y., Ando, M., Katsumata, N., Okumura, A., Ohta, M., Fujii, H., Sasaki, Y., Niwa, T., et al. (1999) · British Journal of Cancer · doi:10.1038/sj.bjc.6690343 · Cited by 114
Age-Related Lymphatic Dysfunction in Melanoma Patients
Conway, W. C., Faries, M. B., Nicholl, M. B., Terando, A. M., Glass, E. C., Sim, M., & Morton, D. L. (2009) · Annals of Surgical Oncology · doi:10.1245/s10434-009-0420-x · Cited by 113
A Physiologically Based Pharmacokinetic Modeling Approach to Predict Disease–Drug Interactions: Suppression of CYP3A by IL-6
Machavaram, K. K., Almond, L. M., Rostami‐Hodjegan, A., Gardner, I., Jamei, M., Tay, S., Wong, S., Joshi, A., & Kenny, J. R. (2013) · Clinical Pharmacology & Therapeutics · doi:10.1038/clpt.2013.79 · Cited by 111
Self-citation
Population Pharmacokinetics of Infliximab in Patients With Ankylosing Spondylitis
Xu, Z., Seitz, K., Fasanmade, A. A., Ford, J. A., Williamson, P., Xu, W., Davis, H. M., & Zhou, H. (2008) · The Journal of Clinical Pharmacology · doi:10.1177/0091270008316886 · Cited by 109
LYMPHATIC FLOW IN HUMAN SUBJECTS AS INDICATED BY THE DISAPPEARANCE OF I131-LABELED ALBUMIN FROM THE SUBCUTANEOUS TISSUE*†
Hollander, W., Reilly, P. J., & Burrows, B. A. (1961) · Journal of Clinical Investigation · doi:10.1172/jci104248 · Cited by 108
A physiologically based pharmacokinetic (PBPK) model to characterize and predict the disposition of monoclonal antibody CC49 and its single chain Fv constructs
Davda, J. P., Jain, M., Batra, S. K., Gwilt, P. R., & Robinson, D. H. (2007) · International Immunopharmacology · doi:10.1016/j.intimp.2007.10.023 · Cited by 107
Evaluation of a Catenary PBPK Model for Predicting the In Vivo Disposition of mAbs Engineered for High-Affinity Binding to FcRn
Chen, Y., & Balthasar, J. P. (2012) · The AAPS Journal · doi:10.1208/s12248-012-9395-9 · Cited by 105
Subcutaneous Absorption of Monoclonal Antibodies: Role of Dose, Site of Injection, and Injection Volume on Rituximab Pharmacokinetics in Rats
Kagan, L., Turner, M. R., Balu‐Iyer, S. V., & Mager, D. E. (2011) · Pharmaceutical Research · doi:10.1007/s11095-011-0578-3 · Cited by 105
Physiologically based pharmacokinetic model for T84.66: A monoclonal anti-CEA antibody
Urva, S., Yang, V. C.-M., & Balthasar, J. P. (2009) · Journal of Pharmaceutical Sciences · doi:10.1002/jps.21918 · Cited by 105
Utility of Serum HER2 Extracellular Domain Assessment in Clinical Decision Making: Pooled Analysis of Four Trials of Trastuzumab in Metastatic Breast Cancer
Lennon, S., Barton, C. M., Banken, L., Gianni, L., Marty, M. E., Baselga, J. M., & Leyland-Jones, B. R. (2009) · Journal of Clinical Oncology · doi:10.1200/jco.2008.16.8351 · Cited by 103
Rituximab, Bevacizumab and CHOP (RA-CHOP) in untreated diffuse large B-cell lymphoma: Safety, biomarker and pharmacokinetic analysis
Ganjoo, K. N., An, C., Robertson, M. J., Gordon, L. I., Sen, J. A., Weisenbach, J., Li, S., Weller, E. A., Orazi, A., & Horning, S. J. (2006) · Leukemia & lymphoma/Leukemia and lymphoma · doi:10.1080/10428190600563821 · Cited by 102
Pharmacokinetics and concentration–effect relationship of adalimumab in rheumatoid arthritis
Ternant, D., Ducourau, É., Fuzibet, P., Desvignes, C., Watier, H., Lequerré, T., Loët, X. L., Vittecoq, O., Goupille, P., Mulleman, D., et al. (2014) · British Journal of Clinical Pharmacology · doi:10.1111/bcp.12509 · Cited by 100
An enzyme-linked immunosorbent assay for therapeutic drug monitoring of Cetuximab
Ternant, D., Cézé, N., Piller, F., Degenne, D., Dorval, E., Watier, H., Lecomte, T., & Paintaud, G. (2009) · HAL · Cited by 100
Rationale for Fixed Dosing of Pertuzumab in Cancer Patients Based on Population Pharmacokinetic Analysis
Ng, C. M., Lum, B. L., Giménez, V. C., Kelsey, S. M., & Allison, D. (2006) · Pharmaceutical Research · doi:10.1007/s11095-006-0205-x · Cited by 99
Ontogenetic Development and Distribution of Antibody Transport and Fc Receptor mRNA Expression in Rat Intestine
Martin, M. G., Wu, S. V., & Walsh, J. H. (1997) · Digestive Diseases and Sciences · doi:10.1023/a:1018853506830 · Cited by 98
Subcutaneous Bioavailability of Golimumab at 3 Different Injection Sites in Healthy Subjects
Xu, Z., Wang, Q., Zhuang, Y., Frederick, B., Yan, H., Bouman‐Thio, E., Marini, J. C., Keen, M., Snead, D., Davis, H. M., et al. (2010) · The Journal of Clinical Pharmacology · doi:10.1177/0091270009340782 · Cited by 97
Pharmacokinetics of Cetuximab After Administration of Escalating Single Dosing and Weekly Fixed Dosing in Patients with Solid Tumors
Tan, A. R., Moore, D. F., Hidalgo, M. M., Doroshow, J. H., Poplin, E. A., Goodin, S., Mauro, D. M., & Rubin, E. H. (2006) · Clinical Cancer Research · doi:10.1158/1078-0432.ccr-06-0705 · Cited by 97
Immunogenicity of Therapeutic Proteins
Schellekens, H., & Jiskoot, W. (2013) · CRC Press eBooks · doi:10.3109/9781420044386-10 · Cited by 96
Differences in lymph drainage between swollen and non-swollen regions in arms with breast-cancer-related lymphoedema
Stanton, A. W. B., Svensson, W. E., Mellor, R. H., Peters, A. M., Levick, J. R., & Mortimer, P. S. (2001) · Clinical Science · doi:10.1042/cs1010131 · Cited by 94
Impact of in vivo alemtuzumab dose before reduced intensity conditioning and HLA-identical sibling stem cell transplantation: pharmacokinetics, GVHD, and immune reconstitution
Chakraverty, R. K., Ortí, G., Roughton, M., Shen, J., Fielding, A. K., Kottaridis, P. D., Milligan, D. W., Collin, M. P., Crawley, C. R., Johnson, P. R. E., et al. (2010) · Blood · doi:10.1182/blood-2010-05-286856 · Cited by 94
Therapeutic Monoclonal Antibody Concentration Monitoring: Free or Total?
Kuang, B., King, L., & Wang, H. F. (2010) · Bioanalysis · doi:10.4155/bio.10.64 · Cited by 93
Pharmacokinetic–Pharmacodynamic–Efficacy Analysis of Efalizumab in Patients with Moderate to Severe Psoriasis
Ng, C. M., Joshi, A., Dedrick, R. L., Garovoy, M. R., & Bauer, R. J. (2005) · Pharmaceutical Research · doi:10.1007/s11095-005-5642-4 · Cited by 92
Population Pharmacokinetic Analysis of Panitumumab in Patients With Advanced Solid Tumors
Ma, P., Yang, B., Wang, Y., Peterson, M. C., Narayanan, A., Sutjandra, L., Rodriguez, R. D., & Chow, A. T. (2009) · The Journal of Clinical Pharmacology · doi:10.1177/0091270009344989 · Cited by 91
Phase 1 Trial of Adalimumab in Focal Segmental Glomerulosclerosis (FSGS): II. Report of the FONT (Novel Therapies for Resistant FSGS) Study Group
Joy, M. S., Gipson, D. S., Powell, L., MacHardy, J., Jennette, J. C., Vento, S., Pan, C. G., Savin, V. J., Eddy, A. A., Fogo, A. B., et al. (2009) · American Journal of Kidney Diseases · doi:10.1053/j.ajkd.2009.08.019 · Cited by 87
Critical Review of Preclinical Approaches to Investigate Cytochrome P450–Mediated Therapeutic Protein Drug-Drug Interactions and Recommendations for Best Practices: A White Paper
Evers, R., Dallas, S., Dickmann, L. J., Fahmi, O. A., Kenny, J. R., Kraynov, E. A., Nguyen, T. V., Patel, A. H., Slatter, J. G., & Zhang, L. (2013) · Drug Metabolism and Disposition · doi:10.1124/dmd.113.052225 · Cited by 85
Population Pharmacokinetics of Cetuximab in Patients With Squamous Cell Carcinoma of the Head and Neck
Dirks, N. L., Nolting, A., Kovar, A., & Meibohm, B. (2008) · The Journal of Clinical Pharmacology · doi:10.1177/0091270007313393 · Cited by 84
Evaluation of disease‐mediated therapeutic protein–drug interactions between an anti–interleukin‐6 monoclonal antibody (sirukumab) and cytochrome P450 activities in a phase 1 study in patients with rheumatoid arthritis using a cocktail approach
Zhuang, Y., de Vries, D. E., Xu, Z., Marciniak, S. J., Chen, D., Leon, F., Davis, H. M., & Zhou, H. (2015) · The Journal of Clinical Pharmacology · doi:10.1002/jcph.561 · Cited by 84
Relationship between inflammation and infliximab pharmacokinetics in rheumatoid arthritis
Ternant, D., Ducourau, É., Perdriger, A., Corondan, A., Goff, B. L., Devauchelle‐Pensec, V., Solau‐Gervais, E., Watier, H., Goupille, P., Paintaud, G., et al. (2013) · British Journal of Clinical Pharmacology · doi:10.1111/bcp.12313 · Cited by 83
An open-label pilot study of the effectiveness of adalimumab in patients with rheumatoid arthritis and previous infliximab treatment: relationship to reasons for failure and anti-infliximab antibody status
van der Bijl, A. E., Breedveld, F. C., Antoni, C., Kalden, J. R., Kary, S., Burmester, G. R., Beckmann, C., Unnebrink, K., & Küpper, H. (2008) · Clinical Rheumatology · doi:10.1007/s10067-008-0866-4 · Cited by 82
Pharmacokinetic profile of cetuximab (Erbitux™) alone and in combination with irinotecan in patients with advanced EGFR-positive adenocarcinoma
Delbaldo, C., Pierga, J., Dieras, V. C., Faivre, S. J., Laurence, V., Vedovato, J.-C., Bonnay, M., Mueser, M., Nolting, A., Kovar, A., et al. (2005) · European Journal of Cancer · doi:10.1016/j.ejca.2005.04.029 · Cited by 80
Free circulating soluble CD52 as a tumor marker in chronic lymphocytic leukemia and its implication in therapy with anti‐CD52 antibodies
Albitar, M. X., Do, K.-A., Johnson, M. M., Giles, F. J., Jilani, I. B., O'Brien, S. M., Cortes, J. E., Thomas, D. A., Rassenti, L. Z., Kipps, T. J., et al. (2004) · Cancer · doi:10.1002/cncr.20477 · Cited by 79
Human and Non-Human Primate Intestinal FcRn Expression and Immunoglobulin G Transcytosis
Hornby, P. J., Cooper, P. R., Kliwinski, C., Ragwan, E., Mabus, J. R., Harman, B., Thompson, S., Kauffman, A. L., Yan, Z., Tam, S. H., et al. (2014) · Pharmaceutical Research · doi:10.1007/s11095-013-1212-3 · Cited by 78
Enhanced Fcgamma receptor I, alphaMbeta2 integrin receptor expression by monocytes and neutrophils in rheumatoid arthritis: interaction with platelets.
Bunescu, A., Seideman, P., Lenkei, R., Levin, K., & Egberg, N. (2004) · PubMed · Cited by 75
An Overview of the Pharmacokinetics and Pharmacodynamics of Efalizumab: A Monoclonal Antibody Approved for Use in Psoriasis
Joshi, A., Bauer, R. J., Kuebler, P., White, M., Leddy, C., Compton, P. G., Garovoy, M. R., Kwon, P., Walicke, P. A., & Dedrick, R. L. (2006) · The Journal of Clinical Pharmacology · doi:10.1177/0091270005283282 · Cited by 70
Physiologically Based Pharmacokinetic Model to Assess the Influence of Blinatumomab‐Mediated Cytokine Elevations on Cytochrome P450 Enzyme Activity
Xu, Y. Y., Hijazi, Y., Wolf, A., Wu, B. M., Sun, Y., & Zhu, M. (2015) · CPT Pharmacometrics & Systems Pharmacology · doi:10.1002/psp4.12003 · Cited by 69
Half-life of the maternal IgG1 allotype in infants
Sarvas, H. O., Seppälä, I., Kurikka, S., Siegberg, R., & Mäkelä, O. (1993) · Journal of Clinical Immunology · doi:10.1007/bf00919271 · Cited by 67
ING-1, a Monoclonal Antibody Targeting Ep-CAM in Patients with Advanced Adenocarcinomas
Bono, J. S. D., Tolcher, A. W., Forero-Torres, A., Vanhove, G. F. A., Takimoto, C. H. M., Bauer, R. J., Hammond, L. A., Patnaik, A., White, M., Shen, S., et al. (2004) · Clinical Cancer Research · doi:10.1158/1078-0432.ccr-04-0729 · Cited by 67
An Enzyme-Linked Immunosorbent Assay for Therapeutic Drug Monitoring of Cetuximab
Cézé, N., Ternant, D., Piller, F., Degenne, D., Azzopardi, N., Dorval, E. D., Watier, H., Lecomte, T., & Paintaud, G. (2009) · Therapeutic Drug Monitoring · doi:10.1097/ftd.0b013e3181b33da3 · Cited by 66
A quantitative lymphoscintigraphic evaluation of lymphatic function in the swollen hands of women with lymphoedema following breast cancer treatment
Stanton, A. W. B., Modi, S., Mellor, R. H., Peters, A. M., Svensson, W. E., Levick, J. R., & Mortimer, P. S. (2006) · Clinical Science · doi:10.1042/cs20050277 · Cited by 66
Disposition and immunodynamics of basiliximab in liver allograft recipients
Kovarik, J. M., Breidenbach, T., Gerbeau, C., Korn, A., Schmidt, A.-G., & Nashan, B. (1998) · Clinical Pharmacology & Therapeutics · doi:10.1016/s0009-9236(98)90024-8 · Cited by 63
Simulation of Monoclonal Antibody Pharmacokinetics in HumansUsing a Minimal Physiologically Based Model
Li, L., Gardner, I. B., Dostálek, M., & Jamei, M. (2014) · The AAPS Journal · doi:10.1208/s12248-014-9640-5 · 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
Evaluation of Pre-existing Antibody Presence as a Risk Factor for Posttreatment Anti-drug Antibody Induction: Analysis of Human Clinical Study Data for Multiple Biotherapeutics
Xue, L., & Rup, B. J. (2013) · The AAPS Journal · doi:10.1208/s12248-013-9497-z · Cited by 63
Assessment of the Influence of Inflammation and FCGR3A Genotype on Infliximab Pharmacokinetics and Time to Relapse in Patients with Crohn’s Disease
Ternant, D., Berkane, Z., Picon, L., Gouilleux‐Gruart, V., Colombel, J., Allez, M., Louis, E. J., & Paintaud, G. (2014) · Clinical Pharmacokinetics · doi:10.1007/s40262-014-0225-3 · Cited by 63
Pharmacokinetics and Pharmacodynamics of Multiple Weekly Subcutaneous Efalizumab Doses in Patients With Plaque Psoriasis
Mortensen, D. L., Walicke, P. A., Wang, X., Kwon, P., Kuebler, P., Gottlieb, A. B., Krueger, J. G., Leonardi, C. L., Miller, B. H., & Joshi, A. (2005) · The Journal of Clinical Pharmacology · doi:10.1177/0091270004270260 · Cited by 62
Age‐Related Changes in the Liver Sinusoidal Endothelium
Couteur, D. G. L., Cogger, V. C., McCuskey, R. S., de Cabo, R., Smedsrød, B. H., Sørensen, K. K., Warren, A., & Fraser, R. (2007) · Annals of the New York Academy of Sciences · doi:10.1196/annals.1396.003 · Cited by 60
Absorption, Distribution, Metabolism, and Excretion (ADME) Studies of Biotherapeutics for Autoimmune and Inflammatory Conditions
Vugmeyster, Y., Harrold, J. M., & Xu, X. (2012) · The AAPS Journal · doi:10.1208/s12248-012-9385-y · Cited by 60
Lower etanercept levels are associated with high disease activity in ankylosing spondylitis patients at 24 weeks of follow-up
Kneepkens, E. L., Krieckaert, C. L. M., van der Kleij, D., Nurmohamed, M. T., van der Horst-Bruinsma, I. E., Rispens, T., & Wolbink, G. (2014) · Annals of the Rheumatic Diseases · doi:10.1136/annrheumdis-2014-205213 · Cited by 60
Access to the Spleen Microenvironment through Lymph Shows Local Cytokine Production, Increased Cell Flux, and Altered Signaling of Immune Cells during Lipopolysaccharide-Induced Acute Inflammation
Semaeva, E., Tenstad, O., Skavland, J., Enger, M., Iversen, P. O., Gjertsen, B. T., & Wiig, H. (2010) · The Journal of Immunology · doi:10.4049/jimmunol.0902049 · Cited by 59
Population Pharmacokinetics of Efalizumab (Humanized Monoclonal Anti‐CD11a Antibody) Following Long‐Term Subcutaneous Weekly Dosing in Psoriasis Subjects
Sun, Y., Lü, J., Joshi, A., Compton, P. G., Kwon, P., & Bruno, R. (2005) · The Journal of Clinical Pharmacology · doi:10.1177/0091270004272731 · Cited by 55
Down-regulation of activating Fcγ receptors on monocytes of patients with rheumatoid arthritis upon methotrexate treatment
Wijngaarden, S., van Roon, J. A. G., van de Winkel, J. G. J., Bijlsma, J. W. J., & Lafeber, F. P. J. G. (2005) · Lara D. Veeken · doi:10.1093/rheumatology/keh583 · Cited by 55
Compartmental distribution of tumor-specific monoclonal antibodies in human melanoma xenografts.
Shockley, T. R., Lin, K., Nagy, J. A., Tompkins, R. G., Yarmush, M. L., & Dvorak, H. F. (1992) · PubMed · Cited by 55
A rational dosing algorithm for basiliximab (Simulect) in pediatric renal transplantation based on pharmacokinetic-dynamic evaluations1
Kovarik, J. M., Offner, G., Broyer, M., Niaudet, P., Loirat, C., Mentser, M. I., Lemire, J. M., Crocker, J. F. S., Cochat, P., Clark, G., et al. (2002) · Transplantation · doi:10.1097/00007890-200210150-00011 · Cited by 54
Three new assays for rituximab based on its immunological activity or antigenic properties: analyses of sera and plasmas of RTX-treated patients with chronic lymphocytic leukemia and other B cell lymphomas
Beum, P. V., Kennedy, A. D., & Taylor, R. P. (2004) · Journal of Immunological Methods · doi:10.1016/j.jim.2004.03.012 · Cited by 54
Stratification of Antibody-Positive Subjects by Antibody Level Reveals an Impact of Immunogenicity on Pharmacokinetics
Zhou, L., Hoofring, S. A., Wu, Y. C., Vu, T. C., Ma, P., Swanson, S. J., Chirmule, N. B., & Starcevic, M. (2012) · The AAPS Journal · doi:10.1208/s12248-012-9408-8 · Cited by 54
Inefficacy of infliximab in ankylosing spondylitis is correlated with antibody formation
de Vries, M. K., Wolbink, G., Stapel, S. O., de Groot, E. R., Dijkmans, B. A. C., Aarden, L. A., & van der Horst-Bruinsma, I. E. (2006) · Annals of the Rheumatic Diseases · doi:10.1136/ard.2006.057745 · Cited by 54
A Mathematical Model of the Effect of Immunogenicity on Therapeutic Protein Pharmacokinetics
Chen, X., Hickling, T. P., Kraynov, E. A., Kuang, B., Parng, C., & Vicini, P. (2013) · The AAPS Journal · doi:10.1208/s12248-013-9517-z · Cited by 53
Targeted Antiepidermal Growth Factor Receptor (Cetuximab) Immunoliposomes Enhance Cellular Uptake In Vitro and Exhibit Increased Accumulation in an Intracranial Model of Glioblastoma Multiforme
Mortensen, J. H., Jeppesen, M., Pilgaard, L., Agger, R., Duroux, M. C., Zachar, V., & Moos, T. (2013) · Journal of Drug Delivery · doi:10.1155/2013/209205 · 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
Population pharmacokinetics of golimumab in patients with ankylosing spondylitis: impact of body weight and immunogenicity
Xu, Z., Lee, H. C., Vu, T., Hu, C., Yan, H., Baker, D., Hsu, B. L., Pendley, C. E., Wagner, C., Davis, H. M., et al. (2010) · International Journal of Clinical Pharmacology and Therapeutics · doi:10.5414/cpp48596 · Cited by 52
Asialoglycoprotein Receptor Expression in Murine Pregnancy and Development
Collins, J. C., Stockert, R. J., & Morell, A. G. (1984) · Hepatology · doi:10.1002/hep.1840040114 · Cited by 51
Are endosomal trafficking parameters better targets for improving mAb pharmacokinetics than FcRn binding affinity?
Gurbaxani, B. M., Dostálek, M., & Gardner, I. B. (2013) · Molecular Immunology · doi:10.1016/j.molimm.2013.05.008 · Cited by 51
Soluble human epidermal growth factor receptor 2 (HER2) levels in patients with HER2‐positive breast cancer receiving chemotherapy with or without trastuzumab: Results from North Central Cancer Treatment Group adjuvant trial N9831
Moreno‐Aspitia, A., Hillman, D. W., Dyar, S., Tenner, K., Gralow, J. R., Kaufman, P. A., Davidson, N. E., Lafky, J. M., Reinholz, M. M., Lingle, W. L., et al. (2013) · Cancer · doi:10.1002/cncr.28130 · Cited by 50
A population pharmacokinetic screen to identify demographic-clinical covariates of basiliximab in liver transplantation
Kovarik, J. M. (2001) · Clinical Pharmacology & Therapeutics · doi:10.1067/mcp.2001.114887 · Cited by 49
Mechanisms of Subcutaneous Absorption of Rituximab in Rats
Kagan, L., & Mager, D. E. (2012) · Drug Metabolism and Disposition · doi:10.1124/dmd.112.048496 · Cited by 49
Interleukin-6-receptor polymorphisms rs12083537, rs2228145, and rs4329505 as predictors of response to tocilizumab in rheumatoid arthritis
Enevold, C., Baslund, B., Linde, L., Josephsen, N. L., Tarp, U., Lindegaard, H., Jacobsen, S., & Nielsen, C. H. (2014) · Pharmacogenetics and Genomics · doi:10.1097/fpc.0000000000000071 · Cited by 47
Therapeutic Protein Drug–Drug Interactions: Navigating the Knowledge Gaps–Highlights from the 2012 AAPS NBC Roundtable and IQ Consortium/FDA Workshop
Kenny, J. R., Liu, M. M., Chow, A. T., Earp, J. C., Evers, R., Slatter, J. G., Wang, D. D., Zhang, L., & Zhou, H. (2013) · The AAPS Journal · doi:10.1208/s12248-013-9495-1 · Cited by 47
Down regulation of Fc and complement receptors on B cells in rheumatoid arthritis
Prokopec, K. E., Rhodiner, M., Matt, P., Lindqvist, U. R. C., & Kleinau, S. (2010) · Clinical Immunology · doi:10.1016/j.clim.2010.08.006 · Cited by 46
Clinical Feasibility of Noninvasive Visualization of Lymphatic Flow with Principles of Spin Labeling MR Imaging: Implications for Lymphedema Assessment
Levendovszky, S. R., Donahue, P. M. C., Towse, T., Ridner, S. H., Chappell, M. A., Jordi, J., Gore, J. C., & Donahue, M. J. (2013) · Radiology · doi:10.1148/radiol.13120145 · Cited by 46
Monoclonal antibody disposition: a simplified PBPK model and its implications for the derivation and interpretation of classical compartment models
Fronton, L., Pilari, S., & Huisinga, W. (2014) · Journal of Pharmacokinetics and Pharmacodynamics · doi:10.1007/s10928-014-9349-1 · Cited by 44
Effects of receptor-specific antibody on the uptake of desialylated glycoproteins in the isolated perfused rat liver.
Stockert, R. J., Gärtner, U., Morell, A., & Wolkoff, A. W. (1980) · Journal of Biological Chemistry · doi:10.1016/s0021-9258(19)85596-5 · Cited by 43
An open-label safety and drug interaction study of natalizumab (Antegren™) in combination with interferon-beta (Avonex®) in patients with multiple sclerosis
Vollmer, T. R., Phillips, J. T., Goodman, A. D., Agius, M. A., Libonati, M., Giacchino, J. L., & Grundy, J. S. (2004) · Multiple Sclerosis Journal · doi:10.1191/1352458504ms1084oa · Cited by 43
The Role of Fcγ Receptor Polymorphisms in the Response to Anti–Tumor Necrosis Factor Therapy in Psoriasis
Julià, M., Guilabert, A., Lozano, F., Suárez-Casasús, B., Moreno, N., Carrascosa, J. M., Ferrándiz, C., Pedrosa, E., Alsina‐Gibert, M., & Mascaró, J. M. (2013) · JAMA Dermatology · doi:10.1001/jamadermatol.2013.4632 · Cited by 43
Pharmacokinetics, Pharmacodynamics, and Immunogenicity of Belatacept in Adult Kidney Transplant Recipients
Shen, J., Townsend, R. C., You, X. X., Shen, Y., Zhan, P., Zhou, Z., Geng, D., Wu, D., McGirr, N., Soucek, K. M., et al. (2013) · Clinical Drug Investigation · doi:10.1007/s40261-013-0153-2 · Cited by 43
Gatabolism and Distribution of Gammaglobulin A Preliminary Study with131I‐labelled Gammaglobulin
Birke, G., Liljedahl, S. ‐., Olhagen, B., Plantin, L. O., & Ahlinder, S. (1963) · Acta Medica Scandinavica · doi:10.1111/j.0954-6820.1963.tb17443.x · Cited by 42
Pharmacokinetic and pharmacodynamic properties of canakinumab in patients with gouty arthritis
Chakraborty, A., Van, L. M., Skerjanec, A., Floch, D., Klein, U. R., Krammer, G., Sunkara, G., & Howard, D. (2013) · The Journal of Clinical Pharmacology · doi:10.1002/jcph.162 · Cited by 42
Basiliximab in pediatric liver transplantation: A pharmacokinetic‐derived dosing algorithm
Kovarik, J. M., Gridelli, B. G., Martin, S. R., Rodeck, B., Melter, M., Dunn, S. P., Merion, R. M., Tzakis, A. G., Alonso, E. V., Bucuvalas, J. C., et al. (2002) · Pediatric Transplantation · doi:10.1034/j.1399-3046.2002.01086.x · Cited by 42
Incorporating Target Shedding Into a Minimal PBPK–TMDD Model for Monoclonal Antibodies
Li, L., Gardner, I., Rose, R. H., & Jamei, M. (2014) · CPT Pharmacometrics & Systems Pharmacology · doi:10.1038/psp.2013.73 · Cited by 41
Self-citation
Pharmacokinetics and Pharmacokinetic–Pharmacodynamic Relationships of Monoclonal Antibodies in Children
Edlund, H., Melin, J., Parra-Guillen, Z. P., & Kloft, C. (2014) · Clinical Pharmacokinetics · doi:10.1007/s40262-014-0208-4 · Cited by 39
Asialoglycoprotein receptor in human isolated hepatocytes from normal liver and its apparent increase in liver with histological alterations
Eisenberg, C., Séta, N., Appel, M., Feldmann, G., Durand, G., & Féger, J. (1991) · Journal of Hepatology · doi:10.1016/0168-8278(91)90073-k · Cited by 39
Risk-based strategy for the assessment of pharmacokinetic drug–drug interactions for therapeutic monoclonal antibodies
Zhou, H., & Davis, H. M. (2009) · Drug Discovery Today · doi:10.1016/j.drudis.2009.05.014 · Cited by 38
AAPS Workshop Report: Strategies to Address Therapeutic Protein–Drug Interactions during Clinical Development
Girish, S., Martin, S. W., Peterson, M. C., Zhang, L. K., Zhao, H., Balthasar, J. P., Evers, R., Zhou, H., Zhu, M., Klunk, L. J., et al. (2011) · The AAPS Journal · doi:10.1208/s12248-011-9285-6 · Cited by 36
Prediction of the Pharmacokinetics, Pharmacodynamics, and Efficacy of a Monoclonal Antibody, Using a Physiologically Based Pharmacokinetic FcRn Model
Chetty, M., Li, L., Rose, R. H., Machavaram, K. K., Jamei, M., Rostami‐Hodjegan, A., & Gardner, I. B. (2015) · Frontiers in Immunology · doi:10.3389/fimmu.2014.00670 · Cited by 36
Self-citation
The Utility of Modeling and Simulation Approaches to Evaluate Immunogenicity Effect on the Therapeutic Protein Pharmacokinetics
Ruixo, J. J. P., Ma, P., & Chow, A. T. (2012) · The AAPS Journal · doi:10.1208/s12248-012-9424-8 · Cited by 35
Pharmacokinetics and immunodynamics of chimeric IL-2 receptor monoclonal antibody SDZ CHI 621 in renal allograft recipients
Kovarik, J. M., Rawlings, E., Sweny, P., Fernando, O. N., Moore, R. H., Griffin, P., Fauchald, P., Albrechtsen, D., Sødal, G., Nordal, K., et al. (1996) · Transplant International · doi:10.1111/j.1432-2277.1996.tb01641.x · Cited by 34
Mechanism-based approach using a biomarker response to evaluate tocilizumab subcutaneous injection in patients with rheumatoid arthritis with an inadequate response to synthetic DMARDs (MATSURI study)
Ohta, S., Tsuru, T., Terao, K., Mogi, S., Suzaki, M., Shono, E., Ishida, Y., Tarumi, E., & Imai, M. (2013) · Journal of clinical pharmacology · doi:10.1002/jcph.185 · Cited by 33
Pharmacokinetic and Pharmacodynamic Characteristics of Single-dose Canakinumab in Patients With Type 2 Diabetes Mellitus
Noè, A., Howard, C. P., Thuren, T. Y., Taylor, A. E., & Skerjanec, A. (2014) · Clinical Therapeutics · doi:10.1016/j.clinthera.2014.08.004 · Cited by 33
Interspecies Pharmacokinetic Modeling of Subcutaneous Absorption of Rituximab in Mice and Rats
Kagan, L., Zhao, J., & Mager, D. E. (2014) · Pharmaceutical Research · doi:10.1007/s11095-014-1416-1 · Cited by 32
Constructing a Prediction Interval for Time to Reach a Threshold Concentration Based on a Population Pharmacokinetic Analysis: An Application to Basiliximab in Renal Transplantation
Mentré, F., Kovarik, J. M., & Gerbeau, C. (1999) · Journal of Pharmacokinetics and Biopharmaceutics · doi:10.1023/a:1020658023774 · Cited by 31
Three monthly doses of palivizumab are not adequate for 5-month protection: A population pharmacokinetic analysis
Via, W. V. L., Notario, G. F., Yu, X., Sharma, S., Noertersheuser, P. A., & Robbie, G. J. (2013) · Pulmonary Pharmacology & Therapeutics · doi:10.1016/j.pupt.2013.03.007 · Cited by 30
Low infliximab serum trough levels and anti-infliximab antibodies are prevalent in rheumatoid arthritis patients treated with infliximab in daily clinical practice: results of an observational cohort study
van der Maas, A., van den Bemt, B. J. F., Wolbink, G., van den Hoogen, F. H. J., van Riel, P. L. C. M., & den Broeder, A. A. (2012) · BMC Musculoskeletal Disorders · doi:10.1186/1471-2474-13-184 · Cited by 29
Wetting Properties of Bile Salt Solutions and Dissolution Media
Luner, P. E. (2000) · Journal of Pharmaceutical Sciences · doi:10.1002/(sici)1520-6017(200003)89:3 · Cited by 29
Contribution of FcRn binding to intestinal uptake of IgG in suckling rat pups and human FcRn-transgenic mice
Kliwinski, C. M., Cooper, P. R., Perkinson, R. A., Mabus, J. R., Tam, S. H., Wilkinson, T. M., Giles-Komar, J. M., Scallon, B. J., Powers, G. D., & Hornby, P. J. (2012) · American Journal of Physiology-Gastrointestinal and Liver Physiology · doi:10.1152/ajpgi.00340.2012 · Cited by 29
Pharmacokinetic mAb–mAb Interaction: Anti-VEGF mAb Decreases the Distribution of Anti-CEA mAb into Colorectal Tumor Xenografts
Abuqayyas, L., & Balthasar, J. P. (2012) · The AAPS Journal · doi:10.1208/s12248-012-9357-2 · Cited by 29
Population pharmacokinetic data analysis of three phase I studies of matuzumab, a humanised anti-EGFR monoclonal antibody in clinical cancer development
Kuester, K., Kovar, A., Lüpfert, C., Brockhaus, B., & Kloft, C. (2008) · British Journal of Cancer · doi:10.1038/sj.bjc.6604265 · Cited by 28
Contribution of Renal and Non‐Renal Clearance on Increased Total Clearance of Adalimumab in Glomerular Disease
Roberts, B. V., Susano, I., Gipson, D. S., Trachtman, H., & Joy, M. S. (2013) · The Journal of Clinical Pharmacology · doi:10.1002/jcph.121 · Cited by 26
Bioequivalence of a Novel Omalizumab Solution for Injection Compared with the Standard Lyophilized Powder Formulation
Rivière, G., Yeh, C. M., Reynolds, C., & Brookman, L. J. (2011) · Journal of Bioequivalence & Bioavailability · doi:10.4172/jbb.1000075 · Cited by 25
How Current Understanding of Clearance Mechanisms and Pharmacodynamics of Therapeutic Proteins Can Be Applied for Evaluation of Their Drug-Drug Interaction Potential
Kraynov, E. A., Martin, S. W., Hurst, S. I., Fahmi, O. A., Dowty, M. E., Cronenberger, C., Loi, C., Kuang, B., Fields, O., Fountain, S. T., et al. (2011) · Drug Metabolism and Disposition · doi:10.1124/dmd.111.040808 · Cited by 25
Genetic Polymorphisme of FCGRT Encoding FcRn in a Japanese Population and Their Functional Analysis
Ishii‐Watabe, A., Saito, Y., Suzuki, T., Tada, M., Ukaji, M., Maekawa, K., Kurose, K., Kaniwa, N., Sawada, J.-I., Kawasaki, N., et al. (2010) · Drug Metabolism and Pharmacokinetics · doi:10.2133/dmpk.dmpk-10-rg-067 · Cited by 23
Development of a PBPK Model for Monoclonal Antibodies and Simulation of Human and Mice PBPK of a Radiolabelled Monoclonal Antibody
Heiskanen, T., Heiskanen, T., & Kairemo, K. (2009) · Current Pharmaceutical Design · doi:10.2174/138161209787581968 · Cited by 23
Ethnic variation of Fcγ receptor polymorphism in Sami and Norwegian populations
Torkildsen, Ø., Utsi, E., Mellgren, S. I., Harbo, H. F., Vedeler, C. A., & Myhr, K. (2005) · Immunology · doi:10.1111/j.1365-2567.2005.02158.x · Cited by 22
Pharmacokinetic study and Fcγ receptor gene analysis in two patients with rheumatoid arthritis controlled by low-dose infliximab
Nishio, S., Yamamoto, T., Kaneko, K., Tanaka-Matsumoto, N., Muraoka, S., Kaburaki, M., Kusunoki, Y., Takagi, K., & Kawai, S. (2009) · Modern Rheumatology · doi:10.1007/s10165-009-0158-0 · Cited by 21
Hypercatabolism of IgG in mice with lupus-like syndrome
Zhou, J., Pop, L. M., & Ghetie, V. F. (2005) · Lupus · doi:10.1191/0961203305lu2129oa · Cited by 21
Gray Scale and Power Doppler Sonography of Normal Cervical Lymph Nodes
Ying, M. T. C., Ahuja, A. T., & Brook, F. M. (2002) · Journal of Ultrasound in Medicine · doi:10.7863/jum.2002.21.1.59 · Cited by 21
Pharmacokinetics and pharmacodynamics of tocilizumab after subcutaneous administration in patients with rheumatoid arthritis.
Zhang, X.-P., Chen, Y.-C., Fettner, S., Rowell, L., Gott, T., Grimsey, P., & Unsworth, A. (2013) · International journal of clinical pharmacology and therapeutics · doi:10.5414/cp201904 · Cited by 20
Intratumoral microdistribution of [131I]MB-1 in patients with B-cell lymphoma following radioimmunotherapy
Brown, R. S., Kaminski, M. S., Fisher, S. J., Chang, A. E., & Wahl, R. L. (1997) · Nuclear Medicine and Biology · doi:10.1016/s0969-8051(97)00099-1 · Cited by 20
Predictive Physiologically Based Pharmacokinetic Model for Antibody-Directed Enzyme Prodrug Therapy
Fang, L., & Sun, D. (2008) · Drug Metabolism and Disposition · doi:10.1124/dmd.107.019182 · Cited by 20
Pharmacokinetic study and Fcγ receptor gene analysis in two patients with rheumatoid arthritis controlled by low-dose infliximab
Nishio, S., Yamamoto, T., Kaneko, K., et al. (2009) · Modern Rheumatology · doi:10.3109/s10165-009-0158-0 · Cited by 16
A phase I study of escalated dose subcutaneous alemtuzumab given weekly with rituximab in relapsed chronic lymphocytic leukemia/small lymphocytic lymphoma
Brown, J. R., Messmer, B. T., Werner, L. L., Davids, M. S., Mikler, E., Supko, J. G., Fisher, D. C., LaCasce, A. S., Armand, P. A., Jacobsen, E. D., et al. (2013) · Haematologica · doi:10.3324/haematol.2013.086207 · Cited by 14
Selection of a phase 3 dose regimen for denosumab based on pharmacokinetic (PK), pharmacodynamic (PD), and safety data from multiple subcutaneous (SC) dosing regimens in breast cancer patients (pts) with bone metastases (BM).
Peterson, M. C., Jang, G., Kim, W., Gurrola, E., Kinsey, A., & Dansey, R. (2006) · Journal of Clinical Oncology · doi:10.1200/jco.2006.24.18_suppl.3086 · Cited by 14
Polymorphisms of Neonatal Fc Receptor in Cynomolgus and Rhesus Macaques
Uno, Y., Utoh, M., & Iwasaki, K. (2014) · Drug Metabolism and Pharmacokinetics · doi:10.2133/dmpk.dmpk-14-nt-033 · Cited by 12
Pharmacokinetics and pharmacodynamics of a chimeric interleukin-2 receptor monoclonal antibody, basiliximab, in renal transplantation: a comparison between Japanese and non-Japanese patients
Haba, T., Uchida, K., Katayama, A., Tominaga, Y., Sato, T., Watanabe, I., Inagaki, H., Kimata, T., Goto, K., Morozumi, K., et al. (2001) · Transplantation Proceedings · doi:10.1016/s0041-1345(01)02351-x · Cited by 12
Comprehensive mechanism-based antibody pharmacokinetic modeling
Chabot, J., Dettling, D. E., Jasper, P., & Gomes, B. C. (2011) · Annual International Conference of the IEEE Engineering in Medicine and Biology Society (EMBC) · doi:10.1109/iembs.2011.6091072 · Cited by 11

Flagged first, then by citations

Research works printed but not linked: 3

Lentner C. Geigy scientific tables, vol. 1: units of measurement, body fluids, composition of the body, and nutrition. 8th ed. Basel: Wiley; 1981. pp. 217–27.
Kauffman R. Drug therapeutics in the infant and child. In: Yaffe S, Aranda J, editors. Pediatric pharmacology: therapeutic principles in practise. Philadelphia: WB Saunders; 1992. p. 212–9.
Freeman T. Gamma globulin metabolism in normal humans and in patients. Ser Haematol. 1965;4:76–86.

Sorted by citations

Tocilizumab in patients with severe COVID-19: a retrospective cohort study
Guaraldi, G., Meschiari, M., Cozzi-Lepri, A., Milic, J., Tonelli, R., Menozzi, M., Franceschini, E., Cuomo, G., Orlando, G., Borghi, V., et al. (2020) · The Lancet Rheumatology · doi:10.1016/s2665-9913(20)30173-9 · Cited by 939
Tutorial on monoclonal antibody pharmacokinetics and its considerations in early development
Ovacik, M., & Lin, K. (2018) · Clinical and Translational Science · doi:10.1111/cts.12567 · Cited by 299
Immunogenicity of TNF-Inhibitors
Atiqi, S., Hooijberg, F., Loeff, F. C., Rispens, T., & Wolbink, G. (2020) · Frontiers in Immunology · doi:10.3389/fimmu.2020.00312 · Cited by 182
Paper‐Based Antibody Detection Devices Using Bioluminescent BRET‐Switching Sensor Proteins
Tenda, K., van Gerven, B., Arts, R., Hiruta, Y., Merkx, M., & Citterio, D. (2018) · Angewandte Chemie International Edition · doi:10.1002/anie.201808070 · Cited by 151
Peripheral and central nervous system distribution of the CGRP neutralizing antibody [ 125 I] galcanezumab in male rats
Johnson, K. W., Morin, S. M., Wroblewski, V. J., & Johnson, M. P. (2019) · Cephalalgia · doi:10.1177/0333102419844711 · Cited by 107

See all 82

Authors: Gill, K. L., Machavaram, K. K., Rose, R. H., & Chetty, M.
Affiliations: Simcyp (United Kingdom) (GB)
Corresponding author: Chetty, Manoranjenni
ORCID: Gill, Katherine L.
Chetty, Manoranjenni
Venue: Clinical Pharmacokinetics
Publisher: Springer Science and Business Media LLC
Published: 2016-01-27
Volume: 55
Issue: 7
Pages: 789-805
ISSN: 0312-5963 (ISSN-L)
1179-1926
DOI: 10.1007/s40262-015-0361-4
OpenAlex: W2296252503
Cited by: 82
References: 210
Citations by year: 2026: 3 · 2025: 12 · 2024: 9 · 2023: 11 · 2022: 11 · 2021: 7 · 2020: 5 · 2019: 6 · 2018: 10 · 2017: 7 · 2016: 1
FWCI: 1.24
Type: journal article
Language: en
Open access: closed
Licence: www.springer.com/tdm (tdm)
Locations: Clinical Pharmacokinetics (publishedVersion)
PubMed (publishedVersion)
Topics: Life Sciences › Immunology and Microbiology › Immunology › Monoclonal and Polyclonal Antibodies Research
Life Sciences › Immunology and Microbiology › Immunology › Biosimilars and Bioanalytical Methods
Health Sciences › Medicine › Pediatrics, Perinatology and Child Health › Pharmaceutical studies and practices
Keywords: monoclonal antibodies, interindividual variability, pharmacokinetics, covariates, genetic polymorphism, population pharmacokinetic model, physiologically based pharmacokinetic modeling, dosing regimen, disease status, immune status, concomitant medications, comorbidities
MeSH terms: Age Factors, Antibodies, Monoclonal, Body Weights and Measures, Dose-Response Relationship, Drug, Drug Interactions, Ethnicity, Humans, Lymphatic System, Models, Biological, Polymorphism, Genetic, Receptors, Fc, Severity of Illness Index, Sex Factors, Histocompatibility Antigens Class I, Comorbidity

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

Potential Sources of Inter-Subject Variability in Monoclonal Antibody Pharmacokinetics

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