Publications by authors named "Leonid Gibiansky"

41Publications

Application of a Two-Analyte Integrated Population Pharmacokinetic Model to Evaluate the Impact of Intrinsic and Extrinsic Factors on the Pharmacokinetics of Polatuzumab Vedotin in Patients with Non-Hodgkin Lymphoma.

Authors:
Dan Lu Tong Lu Rong Shi Leonid Gibiansky Priya Agarwal Colby S Shemesh Randall C Dere Uzor Ogbu Jamie Hirata Pascal Chanu Sandhya Girish Jin Yan Jin Chunze Li Dale Miles

Pharm Res 2020 Dec 1;37(12):252. Epub 2020 Dec 1.

Department of Clinical Pharmacology, Genentech, Inc, South San Francisco, California, USA.

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December 2020

Pharmacologic effects of oseltamivir in immunocompromised adult patients as assessed by population PK/PD analysis and drug-disease modelling for dosing regimen optimization.

Authors:
Stefan Sturm Annabelle Lemenuel-Diot Kashyap Patel Leonid Gibiansky Rajinder Bhardwaj Patrick F Smith Steve Dang Elke Zwanziger Clare Nasmyth-Miller Patanjali Ravva

Br J Clin Pharmacol 2020 Aug 17. Epub 2020 Aug 17.

Roche Innovation Center New York, Roche Pharmaceutical Research and Early Development, New York, NY, USA.

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August 2020

Asian race and origin have no clinically meaningful effects on polatuzumab vedotin pharmacokinetics in patients with relapsed/refractory B-cell non-Hodgkin lymphoma.

Authors:
Rong Shi Tong Lu Grace Ku Hao Ding Tomohisa Saito Leonid Gibiansky Priya Agarwal Xiaobin Li Jin Yan Jin Sandhya Girish Dale Miles Chunze Li Dan Lu

Cancer Chemother Pharmacol 2020 Sep 8;86(3):347-359. Epub 2020 Aug 8.

Genentech Inc., South San Francisco, CA, USA.

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September 2020

Exposure-safety and exposure-efficacy analyses of polatuzumab vedotin in patients with relapsed or refractory diffuse large B-cell lymphoma.

Authors:
Tong Lu Leonid Gibiansky Xiaobin Li Chunze Li Rong Shi Priya Agarwal Jamie Hirata Dale Miles Pascal Chanu Sandhya Girish Jin Yan Jin Dan Lu

Leuk Lymphoma 2020 12 24;61(12):2905-2914. Epub 2020 Jul 24.

Genentech, Inc, South San Francisco, CA, USA.

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December 2020

Modeling and Simulation of the Pharmacokinetics and Target Engagement of an Antagonist Monoclonal Antibody to Interferon-γ-Induced Protein 10, BMS-986184, in Healthy Participants to Guide Therapeutic Dosing.

Authors:
Weiguo Cai Tarek A Leil Leonid Gibiansky Murli Krishna Hongwei Zhang Huidong Gu Huadong Sun John Throup Subhashis Banerjee Ihab Girgis

Clin Pharmacol Drug Dev 2020 08 18;9(6):689-698. Epub 2020 Feb 18.

Bristol-Myers Squibb, Princeton, New Jersey, USA.

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August 2020

Mechanistic Population Pharmacokinetic Model of Oseltamivir and Oseltamivir Carboxylate Accounting for Physiological Changes to Predict Exposures in Neonates and Infants.

Authors:
Leonid Gibiansky Patanjali Ravva Neil J Parrott Rajinder Bhardwaj Elke Zwanziger Paul Grimsey Barry Clinch Stefan Sturm

Clin Pharmacol Ther 2020 Jul 26;108(1):126-135. Epub 2020 Feb 26.

Roche Innovation Center Basel, Roche Pharmaceutical Research and Early Development, Basel, Switzerland.

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July 2020

Integrated Two-Analyte Population Pharmacokinetic Model of Polatuzumab Vedotin in Patients With Non-Hodgkin Lymphoma.

Authors:
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

CPT Pharmacometrics Syst Pharmacol 2020 01 23;9(1):48-59. Epub 2019 Dec 23.

Genentech Inc., South San Francisco, California, USA.

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January 2020

Exposure-response analysis of venetoclax in combination with rituximab in patients with relapsed or refractory chronic lymphocytic leukemia: pooled results from a phase 1b study and the phase 3 MURANO study.

Authors:
Rong Deng Leonid Gibiansky Tong Lu Xiaobin Li Dan Lu Chunze Li Sandhya Girish Jue Wang Michelle Boyer Noopur Shankar Kathryn Humphrey Kevin J Freise Ahmed Hamed Salem John F Seymour Arnon P Kater Dale Miles

Leuk Lymphoma 2020 01 24;61(1):56-65. Epub 2019 Sep 24.

Genentech Inc, South San Francisco, CA, USA.

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January 2020

Bayesian Population Model of the Pharmacokinetics of Venetoclax in Combination with Rituximab in Patients with Relapsed/Refractory Chronic Lymphocytic Leukemia: Results from the Phase III MURANO Study.

Authors:
Rong Deng Leonid Gibiansky Tong Lu Priya Agarwal Hao Ding Xiaobin Li Smita Kshirsagar Dan Lu Chunze Li Sandhya Girish Jue Wang Michelle Boyer Kathryn Humphrey Kevin J Freise Ahmed Hamed Salem John F Seymour Arnon P Kater Dale Miles

Clin Pharmacokinet 2019 12;58(12):1621-1634

Genentech Inc., South San Francisco, CA, USA.

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December 2019

Pharmacokinetics, exposure, efficacy and safety of obinutuzumab in rituximab-refractory follicular lymphoma patients in the GADOLIN phase III study.

Authors:
Ekaterina Gibiansky Leonid Gibiansky Vincent Buchheit Nicolas Frey Michael Brewster Günter Fingerle-Rowson Candice Jamois

Br J Clin Pharmacol 2019 09 12;85(9):1935-1945. Epub 2019 Jul 12.

Pharma Research and Early Development, Roche Innovation Center Basel, Basel, Switzerland.

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September 2019

Role of obinutuzumab exposure on clinical outcome of follicular lymphoma treated with first-line immunochemotherapy.

Authors:
Candice Jamois Ekaterina Gibiansky Leonid Gibiansky Vincent Buchheit Denis Sahin Guillaume Cartron Robert Marcus Wolfgang Hiddemann John F Seymour Jonathan C Strefford Chantal E Hargreaves Georgina Meneses-Lorente Nicolas Frey Günter Fingerle-Rowson

Br J Clin Pharmacol 2019 07 17;85(7):1495-1506. Epub 2019 May 17.

Pharma Development Oncology, F. Hoffmann-La Roche, Basel, Switzerland.

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July 2019

Pharmacokinetic and Pharmacodynamic Modeling of Serum Etrolizumab and Circulating β7 Receptor Occupancy in Patients With Ulcerative Colitis.

Authors:
Xiaohui Wei Leonid Gibiansky Yehong Wang Franklin Fuh Rich Erickson Sharon O'Byrne Meina T Tang

J Clin Pharmacol 2018 03 26;58(3):386-398. Epub 2017 Nov 26.

Clinical Pharmacology, Genentech, South San Francisco, CA, USA.

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March 2018

Platform model describing pharmacokinetic properties of vc-MMAE antibody-drug conjugates.

Authors:
Matts Kågedal Leonid Gibiansky Jian Xu Xin Wang Divya Samineni Shang-Chiung Chen Dan Lu Priya Agarwal Bei Wang Ola Saad Neelima Koppada Bernard M Fine Jin Y Jin Sandhya Girish Chunze Li

J Pharmacokinet Pharmacodyn 2017 Dec 16;44(6):537-548. Epub 2017 Sep 16.

Clinical Pharmacology, Genentech Inc, 1 DNA Way, South San Francisco, CA, 94080, USA.

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December 2017

Mathematical description of drug-target interactions: application to biologics that bind to targets with two binding sites.

Authors:
Leonid Gibiansky Ekaterina Gibiansky

J Pharmacokinet Pharmacodyn 2018 Feb 16;45(1):23-34. Epub 2017 Sep 16.

QuantPharm LLC, North Potomac, MD, USA.

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February 2018

Target-mediated drug disposition model for drugs with two binding sites that bind to a target with one binding site.

Authors:
Leonid Gibiansky Ekaterina Gibiansky

J Pharmacokinet Pharmacodyn 2017 Oct 19;44(5):463-475. Epub 2017 Jul 19.

QuantPharm LLC, North Potomac, MD, USA.

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October 2017

An Integrated Assessment of the Effects of Immunogenicity on the Pharmacokinetics, Safety, and Efficacy of Elotuzumab.

Authors:
Chaitali Passey Johanna Mora Robert Dodge Leonid Gibiansky Jennifer Sheng Amit Roy Akintunde Bello Manish Gupta

AAPS J 2017 03 9;19(2):557-567. Epub 2017 Jan 9.

Bristol-Myers Squibb, Princeton, New Jersey, USA.

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March 2017

Model-based pharmacokinetic analysis of elotuzumab in patients with relapsed/refractory multiple myeloma.

Authors:
Leonid Gibiansky Chaitali Passey Amit Roy Akintunde Bello Manish Gupta

J Pharmacokinet Pharmacodyn 2016 06 18;43(3):243-57. Epub 2016 Mar 18.

Clinical Pharmacology and Pharmacometrics, Bristol-Myers Squibb, Route 206 & Province Line Road, Princeton, NJ, 08543, USA.

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June 2016

A mechanistic pharmacokinetic/pharmacodynamic model of factor D inhibition in cynomolgus monkeys by lampalizumab for the treatment of geographic atrophy.

Authors:
Kha N Le Leonid Gibiansky Jeremy Good Teresa Davancaze Menno van Lookeren Campagne Kelly M Loyet Alyssa Morimoto Jin Jin Lisa A Damico-Beyer William D Hanley

J Pharmacol Exp Ther 2015 Nov;355(2):288-96

Genentech, Inc., South San Francisco, California.

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November 2015

Investigating clinically adequate concentrations of oseltamivir carboxylate in end-stage renal disease patients undergoing hemodialysis using a population pharmacokinetic approach.

Authors:
Mohamed A Kamal Kayla Yi Ting Lien Richard Robson Vishak Subramoney Barry Clinch Craig R Rayner Leonid Gibiansky

Antimicrob Agents Chemother 2015 Nov 17;59(11):6774-81. Epub 2015 Aug 17.

QuantPharm LLC, North Potomac, Maryland, USA.

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November 2015

Population pharmacokinetic analysis of oseltamivir and oseltamivir carboxylate following intravenous and oral administration to patients with and without renal impairment.

Authors:
Leonid Gibiansky Mylène Giraudon Craig R Rayner Barbara J Brennan Vishak Subramoney Richard Robson Mohamed A Kamal

J Pharmacokinet Pharmacodyn 2015 Jun 29;42(3):225-36. Epub 2015 Mar 29.

QuantPharm LLC, 49 Flints Grove Drive, North Potomac, MD, 20878, USA,

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June 2015