The DOI matches its Crossref record; 33 of the 33 references it cites were found in a registry or an index.
Model-Based Population Pharmacokinetic Analysis of Nivolumab in Patients With Solid Tumors
Open accessAbstract
Nivolumab is a fully human monoclonal antibody that inhibits programmed death-1 activation. The clinical pharmacology profile of nivolumab was analyzed by a population pharmacokinetics model that assessed covariate effects on nivolumab concentrations in 1,895 patients who received 0.3-10.0 mg/kg nivolumab in 11 clinical trials. Nivolumab pharmacokinetics is linear with a time-varying clearance. A full covariate model was developed to assess covariate effects on pharmacokinetic parameters. Nivolumab clearance and volume of distribution increase with body weight. The final model included the effects of baseline performance status (PS), baseline body weight, and baseline estimated glomerular filtration rate (eGFR), sex, and race on clearance, and effects of baseline body weight and sex on volume of distribution in the central compartment. Sex, PS, baseline eGFR, age, race, baseline lactate dehydrogenase, mild hepatic impairment, tumor type, tumor burden, and programmed death ligand-1 expression had a significant but not clinically relevant (<20%) effect on nivolumab clearance.
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Self-citationNivolumab in Previously Untreated Melanoma without BRAF Mutation
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Cited by
Armand, P., Engert, A., Younes, A., Fanale, M., Santoro, A., Zinzani, P. L., Timmerman, J. M., Collins, G. P., Ramchandren, R., Cohen, J. B., et al. (2018) · Journal of Clinical Oncology · doi:10.1200/jco.2017.76.0793 · Cited by 759
Clinical Pharmacokinetics and Pharmacodynamics of Immune Checkpoint Inhibitors
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Davis, K. L., Fox, E., Merchant, M. S., Reid, J. M., Kudgus, R. A., Liu, X., Minard, C. G., Voss, S., Berg, S. L., Weigel, B. J., et al. (2020) · The Lancet Oncology · doi:10.1016/s1470-2045(20)30023-1 · Cited by 337
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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
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Metadata
- Authors
- Bajaj, G., Wang, X., Agrawal, S., Gupta, M., Roy, A., & Feng, Y.
- Venue
- CPT: Pharmacometrics & Systems Pharmacology
- Publisher
- Wiley
- Published
- 2016-12-26
- Volume
- 6
- Issue
- 1
- Pages
- 58-66
- ISSN
- 2163-8306 (ISSN-L)
- OpenAlex
- W2567068937
- Cited by
- 264
- References
- 33
- FWCI
- 13.60
- Type
- journal article
- Language
- en
- Open access
- gold
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- Bajaj, G., Wang, X., Agrawal, S., Gupta, M., Roy, A., & Feng, Y. (2017). Model-Based Population Pharmacokinetic Analysis of Nivolumab in Patients With Solid Tumors. CPT: Pharmacometrics & Systems Pharmacology. https://doi.org/10.1002/psp4.12143
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