Prediction of Human Plasma Concentration-time Profiles of Monoclonal Antibodies from Monkey Data by a Species-invariant Time Method

Animal Scale-Up

Dedrick, R. L. (1973) · Journal of Pharmacokinetics and Biopharmaceutics · doi:10.1007/bf01059667 · Cited by 397 · see citing works

Projecting human pharmacokinetics of therapeutic antibodies from nonclinical data: What have we learned?

Deng, R., Iyer, S., Theil, F.-P., Mortensen, D. L., Fielder, P. J., & Prabhu, S. (2011) · mAbs · doi:10.4161/mabs.3.1.13799 · Cited by 285 · see citing works

Interspecies Pharmacokinetic Scaling and the Evolutionary-Comparative Paradigm

Boxenbaum, H. G. (1984) · Drug Metabolism Reviews · doi:10.3109/03602538409033558 · Cited by 270 · see citing works

Biologic activity and safety of belimumab, a neutralizing anti-B-lymphocyte stimulator (BLyS) monoclonal antibody: a phase I trial in patients with systemic lupus erythematosus

Furie, R. A., Stohl, W., Ginzler, E. M., Becker, M. A., Mishra, N., Chatham, W. W., Merrill, J. T., Weinstein, A., McCune, W. J., Zhong, J., et al. (2008) · Arthritis Research & Therapy · doi:10.1186/ar2506 · Cited by 262 · see citing works

Chronic Administration of Belimumab, a BLyS Antagonist, Decreases Tissue and Peripheral Blood B-Lymphocyte Populations in Cynomolgus Monkeys: Pharmacokinetic, Pharmacodynamic, and Toxicologic Effects

Halpern, W., Lappin, P. B., Zanardi, T. A., Cai, W., Corcoran, M. L., Zhong, J., & Baker, K. P. (2006) · Toxicological Sciences · doi:10.1093/toxsci/kfj148 · Cited by 158 · see citing works

Interspecies pharmacokinetic scaling and the Dedrick plots

Boxenbaum, H. G., & Ronfeld, R. A. (1983) · American Journal of Physiology-Regulatory, Integrative and Comparative Physiology · doi:10.1152/ajpregu.1983.245.6.r768 · Cited by 146 · see citing works

Interspecies Scaling of Therapeutic Monoclonal Antibodies: Initial Look

Ling, J., Zhou, H., Jiao, Q., & Davis, H. M. (2009) · The Journal of Clinical Pharmacology · doi:10.1177/0091270009337134 · Cited by 144 · see citing works

Prediction of Human Pharmacokinetics of Therapeutic Monoclonal Antibodies from Simple Allometry of Monkey Data

Oitate, M., Masubuchi, N., Ito, T., Yabe, Y., Karibe, T., Aoki, T., Murayama, N., Kurihara, A., Okudaira, N., & Izumi, T. (2011) · Drug Metabolism and Pharmacokinetics · doi:10.2133/dmpk.dmpk-11-rg-011 · Cited by 81 · see citing works

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 · see citing works

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 231 · see citing works

Projecting human pharmacokinetics of monoclonal antibodies from nonclinical data: comparative evaluation of prediction approaches in early drug development

Wang, J., Iyer, S., Fielder, P. J., Davis, J. D., & Deng, R. (2016) · Biopharmaceutics & Drug Disposition · doi:10.1002/bdd.1952 · Cited by 69 · see citing works

Allometric scaling of therapeutic monoclonal antibodies in preclinical and clinical settings

Germovsek, E., Cheng, M., & Giragossian, C. (2021) · mAbs · doi:10.1080/19420862.2021.1964935 · Cited by 53 · see citing works

Quantitative Prediction of Human Pharmacokinetics for mAbs Exhibiting Target-Mediated Disposition

Singh, A. P., Krzyżański, W., Martin, S. W., Weber, G. L., Betts, A. M., Ahmad, A. M., Abraham, A. K., Zutshi, A., Lin, J., & Singh, P. (2014) · The AAPS Journal · doi:10.1208/s12248-014-9690-8 · Cited by 53 · see citing works

Predictability of plasma concentration–time curves in humans using single-species allometric scaling of chimeric mice with humanized liver

Sanoh, S., Naritomi, Y., Fujimoto, M., Sato, K., Kawamura, A., Horiguchi, A., Sugihara, K., Kotake, Y., Ohshita, H., Tateno, C., et al. (2015) · Xenobiotica · doi:10.3109/00498254.2015.1007112 · Cited by 52 · see citing works

Importance of cynomolgus monkeys in development of monoclonal antibody drugs

Iwasaki, K., Uno, Y., Utoh, M., & Yamazaki, H. (2018) · Drug Metabolism and Pharmacokinetics · doi:10.1016/j.dmpk.2018.02.003 · Cited by 46 · see citing works

Recent Advances in Translational Pharmacokinetics and Pharmacodynamics Prediction of Therapeutic Antibodies Using Modeling and Simulation

Haraya, K., Tsutsui, H., Komori, Y., & Tachibana, T. (2022) · Pharmaceuticals · doi:10.3390/ph15050508 · Cited by 35 · see citing works

Prediction of active human dose: learnings from 20 years of Merck KGaA experience, illustrated by case studies

Peters, S. A., Petersson, C., Blaukat, A., Halle, J.-P., & Dolgos, H. (2020) · Drug Discovery Today · doi:10.1016/j.drudis.2020.01.002 · Cited by 28 · see citing works

CAT-02-106, a Site-Specifically Conjugated Anti-CD22 Antibody Bearing an MDR1-Resistant Maytansine Payload Yields Excellent Efficacy and Safety in Preclinical Models

Drake, P. M., Carlson, A., McFarland, J. M., Bañas, S., Barfield, R. M., Zmolek, W., Kim, Y. C., Huang, B. C. B., Kudirka, R. A., & Rabuka, D. (2017) · Molecular Cancer Therapeutics · doi:10.1158/1535-7163.mct-17-0776 · Cited by 27 · see citing works

Review of the Existing Translational Pharmacokinetics Modeling Approaches Specific to Monoclonal Antibodies (mAbs) to Support the First-In-Human (FIH) Dose Selection

Pasquiers, B., Benamara, S., Felices, M., Nguyen, L., & Declèves, X. (2022) · International Journal of Molecular Sciences · doi:10.3390/ijms232112754 · Cited by 20 · see citing works

Mechanistic Investigation of the Preclinical Pharmacokinetics and Interspecies Scaling of PF-05231023, a Fibroblast Growth Factor 21–Antibody Protein Conjugate

Giragossian, C., Vage, C., Li, J., Pelletier, K. B., Piche‐Nicholas, N., Rajadhyaksha, M., Liras, J. L., Logan, A., Calle, R. A., & Weng, Y. (2015) · Drug Metabolism and Disposition · doi:10.1124/dmd.114.061713 · Cited by 20 · see citing works

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 · see citing works

Pharmacokinetic comparison of a diverse panel of non-targeting human antibodies as matched IgG1 and IgG2 isotypes in rodents and non-human primates

Walker, K. W., Salimi-Moosavi, H., Arnold, G. E., Chen, Q., Soto, M., Jacobsen, F. W., & Hui, J. O. (2019) · PLoS ONE · doi:10.1371/journal.pone.0217061 · Cited by 16 · see citing works

Pharmacokinetics and Immunogenicity Investigation of a Human Anti-Interleukin-17 Monoclonal Antibody in Non-Naïve Cynomolgus Monkeys

Han, C., Gunn, G. R., Marini, J. C., Shankar, G., Hsu, H. H., & Davis, H. M. (2015) · Drug Metabolism and Disposition · doi:10.1124/dmd.114.062679 · Cited by 14 · see citing works

ADME of Monoclonal Antibody Biotherapeutics: Knowledge Gaps and Emerging Tools

Lee, J. W. (2013) · Bioanalysis · doi:10.4155/bio.13.144 · Cited by 14 · see citing works

Monoclonal Antibodies: From Structure to Therapeutic Application

Davis, J. D., Deng, R., Boswell, C. A., Zhang, Y., Li, J., Fielder, P. J., Joshi, A., & Kenkare-Mitra, S. (2013) · Springer eBooks · doi:10.1007/978-1-4614-6486-0_7 · Cited by 14 · see citing works

A pre-clinical quantitative model predicts the pharmacokinetics/pharmacodynamics of an anti-BDCA2 monoclonal antibody in humans

Biliouris, K., Nestorov, I. A., Naik, H., Dai, D., Xiao, G., Wang, Q. L., Pellerin, A., Rabah, D., Lesko, L. J., & Trame, M. N. (2018) · Journal of Pharmacokinetics and Pharmacodynamics · doi:10.1007/s10928-018-9609-6 · Cited by 13 · see citing works

Simple Approach to Accurately Predict Pharmacokinetics of Therapeutic Monoclonal Antibodies after Subcutaneous Injection in Humans

Haraya, K., & Tachibana, T. (2020) · Clinical Pharmacokinetics · doi:10.1007/s40262-020-00917-8 · Cited by 11 · see citing works

Combination of cassette-dosing and microsampling for reduced animal usage for antibody pharmacokinetics in cynomolgus monkeys, wild-type mice, and human FcRn transgenic mice

Nagayasu, M., & Ozeki, K. (2021) · Pharmaceutical Research · doi:10.1007/s11095-021-03028-6 · Cited by 10 · see citing works

Predicting Method for the Human Plasma Concentration–Time Profile of a Monoclonal Antibody from the Half-life of Non-human Primates

Nakamura, G., Ozeki, K., Nagayasu, M., Nambu, T., Nemoto, T., & Hosoya, K. (2020) · Biological and Pharmaceutical Bulletin · doi:10.1248/bpb.b19-01042 · Cited by 10 · see citing works

Retrospective analysis of model-based predictivity of human pharmacokinetics for anti-IL-36R monoclonal antibody MAB92 using a rat anti-mouse IL-36R monoclonal antibody and RNA expression data (FANTOM5)

Ahlberg, J., Giragossian, C., Li, H., Myzithras, M., Raymond, E., Caviness, G. O., Grimaldi, C. M., Brown, S.-E., Perez, R., Yang, D., et al. (2019) · mAbs · doi:10.1080/19420862.2019.1615345 · Cited by 8 · see citing works

Prediction of non-linear pharmacokinetics in humans of an antibody-drug conjugate (ADC) when evaluation of higher doses in animals is limited by tolerability: Case study with an anti-CD33 ADC

Figueroa, I., Leipold, D., Leong, S. R., Zheng, B., Carrasco‐Triguero, M., Fourie-O’Donohue, A., Kozak, K. R., Xu, K., Schutten, M. M., Wang, H., et al. (2018) · mAbs · doi:10.1080/19420862.2018.1465160 · Cited by 7 · see citing works

Prediction of Human Pharmacokinetics Profile of Monoclonal Antibody Using hFcRn Transgenic Mouse Model

Nakamura, G., Ozeki, K., Takesue, H., Tabo, M., & Hosoya, K. (2021) · Biological and Pharmaceutical Bulletin · doi:10.1248/bpb.b20-00775 · Cited by 7 · see citing works

Contrasting toxicokinetic evaluations and interspecies pharmacokinetic scaling approaches for small molecules and biologics: applicability to biosimilar development

Offman, E. M., & Edginton, A. N. (2012) · Xenobiotica · doi:10.3109/00498254.2012.744113 · Cited by 6 · see citing works

Application of Mechanistic Pharmacokinetic–Pharmacodynamic Modeling toward the Development of Biologics

Singh, P., Tiwari, A., Abraham, A. K., & Zutshi, A. (2015) · CRC Press eBooks · doi:10.1201/b19023-7 · Cited by 3 · see citing works

Translational pharmacokinetic and pharmacodynamic modelling of the anti-ADAMTS-5 NANOBODY® (M6495) using the neo-epitope ARGS as a biomarker

Pereira, J. N. S., Ottevaere, I., Serruys, B., Guehring, H., Ladel, C. H., & Lindemann, S. (2024) · Journal of Pharmacokinetics and Pharmacodynamics · doi:10.1007/s10928-024-09958-z · Cited by 3 · see citing works

Preclinical Studies to Enable First in Human Clinical Trials

Chopra, R., & Raynaud, F. I. (2020) · Springer eBooks · doi:10.1007/978-3-030-47682-3_3 · Cited by 3 · see citing works

A Quantitative Prediction Method for the Human Pharmacokinetics of Fc-Fusion Proteins

Yokoyama, M., Suzuki, E., Oitate, M., & Watanabe, N. (2023) · European Journal of Drug Metabolism and Pharmacokinetics · doi:10.1007/s13318-023-00845-5 · Cited by 2 · see citing works

Prediction of human serum concentration–time profiles of therapeutic monoclonal antibodies using common marmosets ( Callithrix jacchus ): initial assessment with canakinumab, adalimumab, and bevacizumab

Tajiri, A., Matsumoto, S., Maeda, S., Soga, T., Kagiyama, K., Ikeda, H., Fukasawa, K., Miyata, A., & Kamimura, H. (2024) · Xenobiotica · doi:10.1080/00498254.2024.2371921 · Cited by 1 · see citing works

Prediction of Non-Linear Pharmacokinetics of Monoclonal Antibodies in Human from Nonclinical Data: Are We There Yet?

Yu, Y., Zhao, Q., & Li, G. (2021) · European Journal of Drug Metabolism and Pharmacokinetics · doi:10.1007/s13318-021-00702-3 · Cited by 1 · see citing works

Translate Pharmacokinetics of PD-1/PD-L1 Monoclonal Antibodies from Cynomolgus Monkey to Human: Comparison of Different Approaches

Chen, W., Wang, L., Ruan, Z., Lou, H., & Jiang, B. (2024) · Journal of Pharmaceutical Sciences · doi:10.1016/j.xphs.2024.07.003 · Cited by 1 · see citing works

Prospective prediction of plasma pharmacokinetics of a novel immune-modulating agent in cancer patients after intra-tumoral administration: translation from non-clinical species to humans

Vuppugalla, R., Sane, R., Wichroski, M. J., Gavai, A. V., Boyanapalli, S. S. S., & Yang, Z. (2021) · Xenobiotica · doi:10.1080/00498254.2021.1934606

PBPK MODELING OF BIOTHERAPEUTICS

Peters, S. A. (2021) · Wiley eBooks · doi:10.1002/9781119497813.ch8

Predicting Human Systemic Pharmacokinetics

Chen, E. P. (2025) · Wiley eBooks · doi:10.1002/9781119650263.ch15

Prediction of Human Pharmacokinetics of Therapeutic Monoclonal Antibodies from Simple Allometry of Monkey Data

Oitate, M., Masubuchi, N., Ito, T., Yabe, Y., Karibe, T., Aoki, T., Murayama, N., Kurihara, A., Okudaira, N., & Izumi, T. (2011) · Drug Metabolism and Pharmacokinetics · doi:10.2133/dmpk.dmpk-11-rg-011 · Cited by 81 · see citing works

Quantitative Prediction of Human Pharmacokinetics for Monoclonal Antibodies: Retrospective Analysis of Monkey as a Single Species for First-in-Human Prediction

Dong, J. Q., Salinger, D. H., Endres, C. J., Gibbs, J. P., Hsu, C.-P., Stouch, B. J., Hurh, E., & Gibbs, M. A. (2011) · Clinical Pharmacokinetics · doi:10.2165/11537430-000000000-00000 · Cited by 156 · see citing works

Interspecies Scaling of Therapeutic Monoclonal Antibodies: Initial Look

Ling, J., Zhou, H., Jiao, Q., & Davis, H. M. (2009) · The Journal of Clinical Pharmacology · doi:10.1177/0091270009337134 · Cited by 144 · see citing works

Projecting human pharmacokinetics of therapeutic antibodies from nonclinical data: What have we learned?

Deng, R., Iyer, S., Theil, F.-P., Mortensen, D. L., Fielder, P. J., & Prabhu, S. (2011) · mAbs · doi:10.4161/mabs.3.1.13799 · Cited by 285 · see citing works

A Single Animal Species-Based Prediction of Human Clearance and First-in-Human Dose of Monoclonal Antibodies: Beyond Monkey

Mahmood, I. (2021) · Antibodies · doi:10.3390/antib10030035 · Cited by 11 · see citing works