Sandhya Girish

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

Confounding factors in exposure-response analyses and mitigation strategies for monoclonal antibodies in oncology.

Authors:

Sonoko Kawakatsu René Bruno Matts Kågedal Chunze Li Sandhya Girish Amita Joshi Benjamin Wu

Br J Clin Pharmacol 2020 Nov 20. Epub 2020 Nov 20.

Clinical Pharmacology, Development Sciences, gRED, Genentech/Roche, South San Francisco, CA, USA.

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November 2020

Physiologically Based Pharmacokinetic Model-Informed Drug Development for Polatuzumab Vedotin: Label for Drug-Drug Interactions Without Dedicated Clinical Trials.

Authors:

Divya Samineni Hao Ding Fang Ma Rong Shi Dan Lu Dale Miles Jialin Mao Chunze Li Jin Jin Matthew Wright Sandhya Girish Yuan Chen

J Clin Pharmacol 2020 Oct;60 Suppl 1:S120-S131

Drug Metabolism and Pharmacokinetics, Genentech, Inc., South San Francisco, California, USA.

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October 2020

Impact of Physiologically Based Pharmacokinetics, Population Pharmacokinetics and Pharmacokinetics/Pharmacodynamics in the Development of Antibody-Drug Conjugates.

Authors:

Chunze Li Shang-Chiung Chen Yuan Chen Sandhya Girish Matts Kaagedal Dan Lu Tong Lu Divya Samineni Jin Y Jin

J Clin Pharmacol 2020 Oct;60 Suppl 1:S105-S119

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

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October 2020

Personalized Cancer Vaccines: Clinical Landscape, Challenges, and Opportunities.

Authors:

Colby S Shemesh Joy C Hsu Iraj Hosseini Ben-Quan Shen Anand Rotte Patrick Twomey Sandhya Girish Benjamin Wu

Mol Ther 2020 Sep 30. Epub 2020 Sep 30.

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

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September 2020

Vismodegib Efficacy in Advanced Basal Cell Carcinoma Maintained With 8-Week Dose Interruptions: A Model-Based Evaluation.

Authors:

Pascal Chanu Luna Musib Xin Wang Sravanthi Cheeti Sandhya Girish Rene Bruno Tong Lu Josina Reddy Jin Y Jin Ivor Caro

J Invest Dermatol 2020 Sep 22. Epub 2020 Sep 22.

Product Development, Oncology, Genentech/Roche, South San Francisco, California, USA.

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September 2020

Collaborations between Clinical Pharmacologists in Japan and in the United States - Report from the IQ CPLG and JPMA CPTF Meeting in Tokyo, Japan.

Authors:

Tong Zhu Makoto Kayama Sandhya Girish Vikram Sinha Akintunde Bello Atsuhiro Kawaguchi Richard Czerniak Lee Nagao

Clin Transl Sci 2020 Sep 24. Epub 2020 Sep 24.

Faegre Drinker Biddle & Reath LLP, Washington, DC, USA.

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September 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

Effect of Hepatic Impairment on Cobimetinib Pharmacokinetics: The Complex Interplay Between Physiological Changes and Drug Characteristics.

Authors:

Sravanthi Cheeti Yuzhong Deng Ilsung Chang Isabela Georgescu Ian Templeton Nicholas Choong Kit Wun Kathy Cheung Sandhya Girish Luna Musib

Clin Pharmacol Drug Dev 2020 Jul 21. Epub 2020 Jul 21.

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

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July 2020

Pharmacokinetics of polatuzumab vedotin in combination with R/G-CHP in patients with B-cell non-Hodgkin lymphoma.

Authors:

Colby S Shemesh Priya Agarwal Tong Lu Calvin Lee Randall C Dere Xiaobin Li Chunze Li Jin Y Jin Sandhya Girish Dale Miles Dan Lu

Cancer Chemother Pharmacol 2020 05 28;85(5):831-842. Epub 2020 Mar 28.

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

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May 2020

Clinical pharmacology of vc-MMAE antibody-drug conjugates in cancer patients: learning from eight first-in-human Phase 1 studies.

Authors:

Chunze Li Cindy Zhang Zao Li Divya Samineni Dan Lu Bei Wang Shang-Chiung Chen Rong Zhang Priya Agarwal Bernard M Fine Sandhya Girish

MAbs 2020 Jan-Dec;12(1):1699768

Genentech Research & Early Development, Genentech, Inc, South San Francisco, CA, USA.

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January 2021

Population pharmacokinetics, exposure-safety, and immunogenicity of atezolizumab in pediatric and young adult patients with cancer.

Authors:

Colby S Shemesh Pascal Chanu Kris Jamsen Russ Wada Gianluca Rossato Francis Donaldson Amit Garg Helen Winter Jane Ruppel Xin Wang Rene Bruno Jin Jin Sandhya Girish

J Immunother Cancer 2019 11 21;7(1):314. Epub 2019 Nov 21.

Department of Clinical Pharmacology Oncology, Genentech Inc., South San Francisco, CA, 94080, USA.

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November 2019

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

Alternative dosing regimens for atezolizumab: an example of model-informed drug development in the postmarketing setting.

Authors:

Kari M Morrissey Mathilde Marchand Hina Patel Rong Zhang Benjamin Wu H Phyllis Chan Almut Mecke Sandhya Girish Jin Y Jin Helen R Winter René Bruno

Cancer Chemother Pharmacol 2019 Dec 21;84(6):1257-1267. Epub 2019 Sep 21.

Clinical Pharmacology, Genentech/Roche, 84 Chemin des Grives, 13013, Marseille, France.

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December 2019

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

Time-to-Event Modeling of Peripheral Neuropathy: Platform Analysis of Eight Valine-Citrulline-Monomethylauristatin E Antibody-Drug Conjugates.

Authors:

Matts Kågedal Divya Samineni William R Gillespie Dan Lu Bernard M Fine Sandhya Girish Chunze Li Jin Y Jin

CPT Pharmacometrics Syst Pharmacol 2019 08 10;8(8):606-615. Epub 2019 Jul 10.

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

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August 2019

Pharmacokinetic and exposure-response analysis of pertuzumab in patients with HER2-positive metastatic gastric or gastroesophageal junction cancer.

Authors:

Whitney P Kirschbrown Bei Wang Ihsan Nijem Atsushi Ohtsu Paulo M Hoff Manish A Shah Lin Shen Yoon-Koo Kang Maria Alsina Sandhya Girish Amit Garg

Cancer Chemother Pharmacol 2019 09 10;84(3):539-550. Epub 2019 Jun 10.

Clinical Pharmacology, Genentech Research and Early Development, DNA Way, MS463a, South San Francisco, CA, 94080, USA.

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September 2019

Prediction of Human Pharmacokinetics of Antibody-Drug Conjugates From Nonclinical Data.

Authors:

Chunze Li Cindy Zhang Rong Deng Douglas Leipold Dongwei Li Brandon Latifi Yuying Gao Crystal Zhang Zao Li Dale Miles Shang-Chiung Chen Divya Samineni Bei Wang Priya Agarwal Dan Lu Saileta Prabhu Sandhya Girish Amrita V Kamath

Clin Transl Sci 2019 09 11;12(5):534-544. Epub 2019 Jun 11.

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

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September 2019

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