Zobrazeno 1 - 10
of 95
pro vyhledávání: '"Leonid Gibiansky"'
Autor:
Rong Deng, Leonid Gibiansky, Tong Lu, Christopher R. Flowers, Laurie H. Sehn, Qi Liu, Priya Agarwal, Michael Z. Liao, Randall Dere, Calvin Lee, Gabriel Man, Jamie Hirata, Chunze Li, Dale Miles
Publikováno v:
CPT: Pharmacometrics & Systems Pharmacology, Vol 13, Iss 6, Pp 1055-1066 (2024)
Abstract Polatuzumab vedotin is a CD79b‐directed antibody–drug conjugate that targets B cells and delivers the cytotoxic payload monomethyl auristatin E (MMAE). The phase III POLARIX study (NCT03274492) evaluated polatuzumab vedotin in combinatio
Externí odkaz:
https://doaj.org/article/94a1657630df4f2992ff53a1a61eb869
Publikováno v:
CPT: Pharmacometrics & Systems Pharmacology, Vol 12, Iss 12, Pp 2013-2026 (2023)
Abstract We sought to characterize the population pharmacokinetic/pharmacodynamic (PK/PD) relationship of bococizumab (RN316/PF‐04950615), a humanized IgG2Δa monoclonal antibody that binds to secreted human proprotein convertase subtilisin kexin t
Externí odkaz:
https://doaj.org/article/e3a4824c28c44089a735782ecf1a49fe
Autor:
Michael Z. Liao, Rong Deng, Leonid Gibiansky, Tong Lu, Priya Agarwal, Randall Dere, Calvin Lee, Jamie Hirata, Charles Herbaux, Gilles Salles, Chunze Li, Dale Miles
Publikováno v:
Clinical and Translational Science, Vol 16, Iss 12, Pp 2744-2755 (2023)
Abstract This ethnic sensitivity analysis used data from the phase III POLARIX study (NCT03274492) to assess polatuzumab vedotin pharmacokinetics (PKs) in Asian versus non‐Asian patients with previously untreated diffuse large B‐cell lymphoma and
Externí odkaz:
https://doaj.org/article/8694ec4d77c146a69f093aef77194270
Autor:
Chaitali Passey, Jenna Voellinger, Leonid Gibiansky, Rudy Gunawan, Leonardo Nicacio, Ibrahima Soumaoro, William D. Hanley, Helen Winter, Manish Gupta
Publikováno v:
CPT: Pharmacometrics & Systems Pharmacology, Vol 12, Iss 9, Pp 1262-1273 (2023)
Abstract The antibody‐drug conjugate (ADC) tisotumab vedotin (TV) received accelerated approval from the US Food and Drug Administration for treatment of adults with recurrent or metastatic cervical cancer (r/mCC) with disease progression on or aft
Externí odkaz:
https://doaj.org/article/f763cc3c5c194c33bd0453c17ee0e64a
Autor:
Leonid Gibiansky, Chaitali Passey, Jenna Voellinger, Rudy Gunawan, William D. Hanley, Manish Gupta, Helen Winter
Publikováno v:
CPT: Pharmacometrics & Systems Pharmacology, Vol 11, Iss 10, Pp 1358-1370 (2022)
Abstract Tisotumab vedotin is an investigational antibody–drug conjugate (ADC) for treatment of solid tumors expressing tissue factor with accelerated approval from the US Food and Drug Administration for treatment of recurrent or metastatic cervic
Externí odkaz:
https://doaj.org/article/189ac0ec427e4aaa95dc6b20f855279c
Autor:
Candice Jamois, Leonid Gibiansky, Clarisse Chavanne, Melissa Cheu, Patricia B. Lehane, Pooneh Pordeli, Simone Melega, Jacques Gaudreault
Publikováno v:
Clinical and Translational Science, Vol 15, Iss 9, Pp 2172-2183 (2022)
Abstract Anti‐neutrophil cytoplasmic antibody‐associated vasculitides granulomatosis with polyangiitis (GPA) and microscopic polyangiitis (MPA) are rare, potentially organ‐ and life‐threatening autoimmune conditions affecting adult and pediat
Externí odkaz:
https://doaj.org/article/2c34e1cfb5614cc3ba73e1f72bdbe412
Publikováno v:
CPT: Pharmacometrics & Systems Pharmacology, Vol 10, Iss 8, Pp 914-927 (2021)
Abstract A subcutaneous formulation of the anti‐CD20 antibody rituximab has been developed. Fixed‐dose subcutaneous rituximab delivers noninferior serum trough concentrations (Ctrough), ensuring similar target saturation and comparable efficacy/s
Externí odkaz:
https://doaj.org/article/96de8a1a1020405cb52160c9fa76dd90
Autor:
Dan Lu, Tong Lu, Leonid Gibiansky, Xiaobin Li, Chunze Li, Priya Agarwal, Colby S. Shemesh, Rong Shi, Randall C. Dere, Jamie Hirata, Dale Miles, Pascal Chanu, Sandhya Girish, Jin Yan Jin
Publikováno v:
CPT: Pharmacometrics & Systems Pharmacology, Vol 9, Iss 1, Pp 48-59 (2020)
A two‐analyte integrated population pharmacokinetic (PK) model that simultaneously describes concentrations of antibody‐conjugated monomethyl auristatin E (acMMAE) and unconjugated MMAE following repeated administrations of polatuzumab vedotin (p
Externí odkaz:
https://doaj.org/article/2e23928c346b428697e782202249dc0d
Autor:
Divya Samineni, Leonid Gibiansky, Bei Wang, Shweta Vadhavkar, Richa Rajwanshi, Maneesh Tandon, Arijit Sinha, Othman Al-Sawaf, Kirsten Fischer, Michael Hallek, Ahmed Hamed Salem, Chunze Li, Dale Miles
Publikováno v:
Advances in Therapy. 39:3635-3653
This study aims to investigate pharmacokinetics (PK) and exposure-response parameters of the 400 mg once-daily venetoclax dose regimen in combination with obinutuzumab, which was approved for the first-line (1L) treatment of chronic lymphocytic leuke
Publikováno v:
CPT: Pharmacometrics & Systems Pharmacology, Vol 10, Iss 8, Pp 914-927 (2021)
CPT: Pharmacometrics & Systems Pharmacology
CPT: Pharmacometrics & Systems Pharmacology
A subcutaneous formulation of the anti-CD20 antibody rituximab has been developed. Fixed-dose subcutaneous rituximab delivers non-inferior serum trough concentrations (Ctrough ), ensuring similar target saturation and comparable efficacy/safety to in