2024:
  • Rong Deng, Leonid Gibiansky, Tong Lu, Christopher Flowers, Laurie Sehn, Qi Liu, Priya Agarwal, Michael Liao, Randall Dere, Calvin Lee, Gabriel Man, Jamie Hirata, Chunze Li, and Dale Miles, Population Pharmacokinetics and Exposure-Response Analyses of Polatuzumab Vedotin in Patients with Previously Untreated DLBCL from the POLARIX Study, to appear in CPT: Pharmacometrics & Systems Pharmacology (2024)

  • Michael Z. Liao, Dan Lu, Tong Lu, Leonid Gibiansky, Rong Deng, Divya Samineni, Randall Dere, Andy Lin, Jamie Hirata, Ben-Quan Shen, Donglu Zhang, Dongwei Li, Chunze Li, Dale Miles, Clinical pharmacology strategies to accelerate the development of polatuzumab vedotin and summary of key findings, Advanced Drug Delivery Reviews (2024), Full text

  • Leonid Gibiansky, Chee M Ng, Ekaterina Gibiansky, Target-Mediated Drug Disposition Model for Drugs with N>2 Binding Sites That Bind to a Target with One Binding Site, submitted to Journal of Pharmacokinetics and Pharmacodynamics (2024), Preprint

  • Leonid Gibiansky, Ekaterina Gibiansky, Note On Importance of Correct Stoichiometric Assumptions for Modeling of Monoclonal Antibodies, submitted to Journal of Pharmacokinetics and Pharmacodynamics (2024), Preprint

2023:
  • Tommy Li, Leonid Gibiansky, Apurvasena Parikh, Christopher W. Chiu, Mariana Sacchi, Huaibao Feng, Tahi Ahmadi, Manish Gupta, Steven Xu, Identification of Optimal Dosing Regimen for Subcutaneous Epcoritamab in Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma, Blood (2023) 142 (Supplement 1): 3135, Abstract

  • Tommy Li, Leonid Gibiansky, Apurvasena Parikh, Marcel van der Linden, Kinjal Sanghavi, Matthew Putnins, Mariana Sacchi, Huaibao Feng, Tahamtan Ahmadi, Manish Gupta, Steven Xu, Population Pharmacokinetics of Subcutaneous Epcoritamab in Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma, Blood (2023) 142 (Supplement 1): 4481, Abstract

  • Candice Jamois, David C. Turner, Leonid Gibiansky, Feifei Li, Nicolas Frey, Jean-Francois Menuet, Leonardo Roque Pereira, Linda Lundberg, Elena Guerini, David John Carlile, James Relf, Michael C. Wei, Antonia Kwan, Susan Grange, New Tocilizumab (TCZ) Dosing Guidance for T-Cell Engaging Bispecific Antibody-Related Cytokine Release Syndrome (CRS) in Patients (pts) with Relapsed/Refractory (R/R) B-Cell Non-Hodgkin Lymphoma (B-NHL): Insights from Pooled Clinical Trial Safety Experience and Quantitative Clinical Pharmacology (qCP) Analyses, Blood (2023) 142 (Supplement 1): 1742, Abstract

  • Dietmar Schwab, Sebastien Jolivet, Leonid Gibiansky, Dominik Lott, Systemic exposures of gantenerumab: An integrated population pharmacokinetics (popPK) analysis across multiple clinical studies, Alzheimer's Association International Conference, 2023, Abstract

  • Liao MZ, Deng R, Gibiansky L, Lu T, Agarwal P, Dere R, Lee C, Hirata J, Herbaux C, Salles G, Li C, Miles D., Ethnic sensitivity assessment: Polatuzumab vedotin pharmacokinetics in Asian and non-Asian patients with previously untreated diffuse large B-cell lymphoma in POLARIX, Clin Transl Sci. 2023 Oct 20. doi: 10.1111/cts.13669. Epub ahead of print. PMID: 37864313, Full text

  • Ellen Wang, Nitin Kaila, David Plowchalk, Leonid Gibiansky, Carla Yunis, and Kevin Sweeney, Population PK/PD modeling of low-density lipoprotein cholesterol response in hypercholesterolemic participants following administration of bococizumab, a potent anti-PCSK9 monoclonal antibody, CPT: Pharmacometrics & Systems Pharmacology, November 2023, https://doi.org/10.1002/psp4.13050 Full text

  • Chaitali Passey, Jenna Voellinger, Leonid Gibiansky, Rudy Gunawan, Leonardo Nicacio, Ibrahima Soumaoro, William D Hanley, Helen Winter, Manish Gupta, Exposure-safety and exposure-efficacy analyses for tisotumab vedotin for patients with locally advanced or metastatic solid tumors, CPT: Pharmacometrics & Systems Pharmacology, 2023/7/26, Full text

  • J. Voellinger, C. Passey, Y.S. Feng, R. Gunawan, L. Gibiansky, D. Polhamus, A. Gerritsen, C. O'Day L. Nicacio, I. Soumaoro, M. Gupta, W. Hanley, Tisotumab vedotin (TV) dose schedule optimization in non-cervical populations, Abstract Book of the ESMO Targeted Anticancer Therapies Congress (TAT) 6-8 March 2023, Abstract

  • Hanna Silber Baumann, Sebastien Jolivet, Leonid Gibiansky, Gian-Andrea Thanei, Prune Schlewitz, Xiujing Kou, Petranka Krumova, Jill Smith, Nicolas Frey, Hajime Ito, Siân Lennon-Chrimes, Dose confirmation based on population pharmacokinetics within LUMINESCE (NCT04963270); a Phase III, randomized, double-blind, placebo-controlled study evaluating satralizumab in patients with generalized myasthenia gravis, PAGE 31 (2023) Abstr 10359 [www.page-meeting.org/?abstract=10359], Abstract

2022:
  • Leonid Gibiansky, Chaitali Passey, Jenna Voellinger, Rudy Gunawan, William D. Hanley, Manish Gupta, Helen Winter, Population pharmacokinetic analysis for tisotumab vedotin in patients with locally advanced and/or metastatic solid tumors, CPT: Pharmacometrics & Systems Pharmacology, June 2021, https://doi.org/10.1002/psp4.12850, Open Access

  • Candice Jamois, Leonid Gibiansky, Clarisse Chavanne, Melissa Cheu, Patricia B. Lehane, Pooneh Pordeli, Simone Melega, Jacques Gaudreault, Rituximab pediatric drug development: Pharmacokinetic and pharmacodynamic modeling to inform regulatory approval for rituximab treatment in patients with granulomatosis with polyangiitis or microscopic polyangiitis, ASCPT (2022), CTS: Clinical and Translational Science, https://doi.org/10.1111/cts.13351, Open Access

  • Clemence Pouzin, Leonid Gibiansky, Nathalie Fagniez, Mustapha Chadjaa, Michel Tod and Laurent Nguyen, Integrated multiple analytes and semi-mechanistic population pharmacokinetic model of tusamitamab ravtansine, a DM4 anti-CEACAM5 antibody-drug conjugate, J Pharmacokinet Pharmacodyn (2022). https://doi.org/10.1007/s10928-021-09799-0, Open Access

  • 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, Pharmacokinetics and exposure–response analysis of venetoclax+obinutuzumab in chronic lymphocytic leukaemia: phase 1b study and phase 3 CLL14 trial, Adv Ther (2022),https://doi.org/10.1007/s12325-022-02170-w, Open Access

2021:
  • Ekaterina Gibiansky, Florencio Serrano Castillo, Hossam A Saad, Vincent Chow, Sameer Doshi, Assessing Romiplostim Dose and Platelet Response-Guided Titration to Support Use of Romiplostim in ITP Patients Less Than 12 Months from Diagnosis, Blood (2021) 138 (Supp 1): 4221 , Abstract

  • Divya Samineni, Weize Huang, Leonid Gibiansky, Hao Ding, Rong Zhang, Chunze Li, Arijit Sinha, Richa Rajwanshi, Kathryn Humphrey, Alexandra Bazeos, Ahmed Hamed Salem and Dale Miles , Population Pharmacokinetics and Exposure–Response Analyses for Venetoclax in Combination with R-CHOP in Relapsed/Refractory and Previously Untreated Patients with Diffuse Large B Cell Lymphoma, Adv Ther (2021). https://doi.org/10.1007/s12325-021-01919-z, Full Text Online, Full Text pdf

  • Ekaterina Gibiansky, Leonid Gibiansky, Calibration of an IgG turnover model using data from administration of monoclonal antibodies targeting FcRn receptor, PAGE 2021 Meeting, On the cloud, June 2021, Abstract 9945, Poster III-12

  • Leonid Gibiansky, Hajime Ito, Sian Lennon-Chrimes, Sebastien Jolivet, Patricia Sanwald Ducray, Nicolas Frey, Hanna Silber Baumann, Population pharmacokinetic analysis of Satralizumab in NMOSD patients and healthy volunteers, PAGE 2021 Meeting, On the cloud, June 2021, Abstract 9665

  • Clemence Pouzin, Leonid Gibiansky, Laurent Nguyen, Nathalie Fagniez, Michel Tod, Integrated multiple analytes and semi-mechanistic population pharmacokinetic model of tusamitamab ravtansine, a DM4 anti-CEACAM5 antibody-drug conjugate, PAGE 2021 Meeting, On the cloud, June 2021, Abstract 9650

  • Eric Burroughs Jordie, Leonid Gibiansky, Timothy Knab, Annabelle Lemenuel-Diot, Patanjali Ravva, Elke Zwanziger, Sebastien Jolivet, Rajinder Bhardwaj, Jules Hernández-Sánchez, Clare Nasmyth-Miller, Stefan Sturm, Dosing regimen optimisation for oseltamivir in immunocompromised paediatric patients with influenza: Extrapolation of efficacy, British Journal of Clinical Pharmacology, 27 August 2021,doi: 10.1111/bcp.15059. Abstract,

  • Ekaterina Gibiansky, Leonid Gibiansky, Clarisse Chavanne, Nicolas Frey, and Candice Jamois, Population Pharmacokinetic And Exposure-Response Analyses Of Intravenous And Subcutaneous Rituximab In Patients With Chronic Lymphocytic Leukemia, CPT: Pharmacometrics & Systems Pharmacology, June 2021, https://doi.org/10.1002/psp4.12665 Open Access

  • Candice Jamois, Ekaterina Gibiansky, Leonid Gibiansky, Clarisse Chavanne, Peter N. Morcos, Christine McIntyre, Martin Barrett, Linda Lundberg, Artem Zharkov, Axel Boehnke and Nicolas Frey, Quantitative Clinical Pharmacology Supports the Bridging from IV Dosing and Approval of SC Rituximab in B-Cell Hematological Malignancies, CPT: Pharmacometrics & Systems Pharmacology, May 2021 Abstract

2020:
  • 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, 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, Pharm Res 37, 252 (2020). https://doi.org/10.1007/s11095-020-02933-6, Open Access

  • Candice Jamois, Jacques Gaudreault, Clarisse Chavanne, Melissa Cheu, and Leonid Gibiansky, Population PK and exposure-response analyses supported the first approval of rituximab in pediatrics with Granulomatosis with Polyangiitis (GPA) and Microscopic Polyangiitis (MPA), American Conference on Pharmacometrics (ACoP-11), November 9-12, 2020, Abstract THU-011

  • Ekaterina Gibiansky, Claire Petry, Francois Mercier, Andreas Günther, Ann Herman3, Ludwig Kappos, Stephen Hauser, Yumi Yamamoto, Qing Wang, Fabian Model, Heidemarie Kletzl, Ocrelizumab in relapsing and primary progressive multiple sclerosis: pharmacokinetic and pharmacodynamic analyses of OPERA I, OPERA II and ORATORIO, British Journal of Clinical Pharmacology (2020). https://doi.org/10.1111/bcp.14658, Open Access

  • Xiaofeng Wang, Suresh Mallikaarjun, Ekaterina Gibiansky, Population Pharmacokinetic Analysis of Delamanid in Patients with Pulmonary Multi-Drug Resistant Tuberculosis, Antimicrobial Agents and Chemotherapy Oct 2020, AAC.01202-20; https://doi.org/10.1128/AAC.01202-20, Abstract, Full text

  • Stefan Sturm, Annabelle Lemenuel-Diot, Kashyap Patel, Leonid Gibiansky, Rajinder Bhardwaj, Patrick F. Smith, Steve Dang, Elke Zwanziger, Clare Nasmyth-Miller, Patanjali Ravva, Pharmacologic effects of oseltamivir in immunocompromised adult patients as assessed by population PK/PD analysis and drug‐disease modelling for dosing regimen optimization, British Journal of Clinical Pharmacology, https://doi.org/10.1111/bcp.14523 Open Access

  • 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, Asian race and origin have no clinically meaningful effects on polatuzumab vedotin pharmacokinetics in patients with relapsed/refractory B-cell non-Hodgkin lymphoma, Cancer Chemotherapy and Pharmacology, volume 86, pages 347–359(2020), https://doi.org/10.1007/s00280-020-04119-8, Open Access

  • 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, Exposure-safety and exposure-efficacy analyses of polatuzumab vedotin in patients with relapsed or refractory diffuse large B-cell lymphoma, Leukemia & Lymphoma, https://doi.org/10.1080/10428194.2020.1795154 Open Access

  • Weiguo Cai, Tarek A. Leil, Leonid Gibiansky, Murli Krishna, Hongwei Zhang, Huidong Gu, Huadong Sun, John Throup, Subhashis Banerjee, Ihab Girgis, 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, Clinical Pharmacology in Drug Development, https://doi.org/10.1002/cpdd.784 Open Access

  • Leonid Gibiansky, Patanjali Ravva, Neil John Parrott, Rajinder Bhardwaj, Elke Zwanziger, Paul Grimsey, Barry Clinch, Stefan Sturm, Mechanistic Population Pharmacokinetic Model of Oseltamivir and Oseltamivir Carboxylate Accounting for Physiological Changes to Predict Exposures in Neonates and Infants, Clinical Pharmacology & Therapeutics, https://doi.org/10.1002/cpt.1791 Abstract, Full text

2019:
  • SL Hauser, A Bar-Or, MS Weber, E Gibiansky, H Kletzl, C Petry, F Mercier, A Guenther, A Herman, F Model, Q Wang, G-A Thanei, H Koendgen, L Kappos, Exposure–Response Analyses of Ocrelizumab in Patients With Multiple Sclerosis, Poster 93, Presented at the 27th Annual Meeting of the European Charcot Foundation (ECF); 21–23 November 2019; Baveno, Italy, Abstract

  • 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, Integrated Two‐Analyte Population Pharmacokinetic Model of Polatuzumab Vedotin in Patients with Non‐Hodgkin Lymphoma, CPT: Pharmacometrics & System Pharmacology, November 2019, https://doi.org/10.1002/psp4.12482, Abstract, Open Access

  • Leonid Gibiansky, Ekaterina Gibiansky, Simulation Investigation of the Integrated Pharmacokinetic (PK) Model for Antibody-Drug-Conjugates, American Conference on Pharmacometrics (ACoP10), Orlando, FL, October 20-23, 2019, Abstract W-010, Poster

  • 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 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, Leukemia & Lymphoma, 2019 Sep 24. doi: 10.1080/10428194.2019.1657575. [Epub ahead of print] Abstract

  • Deng R, Gibiansky L, Lu T, Agarwal P, Ding H, Li X, Kshirsagar S, Lu D, Li C, Girish S, Wang J, Boyer M, Humphrey K, Freise KJ, Salem AH, Seymour JF, Kater AP, Miles D, 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, Clin Pharmacokinet. 2019 Jun 18. doi: 10.1007/s40262-019-00788-8. [Epub ahead of print] Abstract

  • Ekaterina Gibiansky, Leonid Gibiansky, Vincent Buchheit, Nicolas Frey, Michael Brewster, Günter Fingerle‐Rowson, Candice Jamois, Pharmacokinetics, exposure, efficacy and safety of obinutuzumab in rituximab‐refractory follicular lymphoma patients in the GADOLIN Phase III study, British Journal of Clinical Pharmacology, First published: 3 May 2019 https://doi.org/10.1111/bcp.13920 Abstract

  • 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, Role of obinutuzumab exposure on clinical outcome of follicular lymphoma treated with first line immunochemotherapy, British Journal of Clinical Pharmacology, First published: 13 March 2019 https://doi.org/10.1111/bcp.13974, Abstract

  • Leonid Gibiansky, Ekaterina Gibiansky, Modeling Approaches to Characterize Target‐Mediated Pharmacokinetics and Pharmacodynamics for Therapeutic Proteins, Chapter 7 in Quantitative Pharmacology and Individualized Therapy Strategies in Development of Therapeutic Proteins for Immune‐Mediated Inflammatory Diseases, Edited by Honghui Zhou and Diane R. Mould © 2019 John Wiley & Sons Inc. Abstract, Table of Contents

  • Leonid Gibiansky, Ekaterina Gibiansky, Tutorial: Numerical (NONMEM) Implementation of the Target‐Mediated Drug Disposition Model, Chapter 8 in Quantitative Pharmacology and Individualized Therapy Strategies in Development of Therapeutic Proteins for Immune‐Mediated Inflammatory Diseases, Edited by Honghui Zhou and Diane R. Mould © 2019 John Wiley & Sons Inc. Abstract, Table of Contents

  • R Shi, T Lu, H Ding, T Saito, L Gibiansky, P Agarwal, X Li, JY Jin, S Girish, et al, Ethnicity Sensitivity Assessment of Polatuzumab Vedotin Pharmacokinetics in Relapsed-Refractory Non-Hodgkin Lymphoma, ASCPT Annual Meeting 2019, Clinical Pharmacology & Ttherapeutics 105, S71

  • H. Kletzl, E Gibiansky, C Petry, F Mercier, A Guenther, Q Wang, F Model, L Kappos, SL Hauser, Pharmacokinetics, Pharmacodynamics and Exposure-Response Analyses of Ocrelizumab in Patients With Multiple Sclerosis, Abstracts of 2019 AAN Annual Meeting, Neurology April 09, 2019; 92 (15 Supplement) Abstract N4.001

  • Fau J‐B, El‐Cheikh R, Brillac C, Koiwai K, Semiond D, Campana F, Nguyen L, and Gibiansky L, Pharmacokinetic time-dependency and covariates modelling of Isatuximab monoclonal antibody in multiple myeloma patients: analysis from pooled phase I/II & phase III studies, PAGE 2019 Meeting, Stockholm, Sweden, June 11-14, 2019, Abstract 8956

2018:
  • Leonid Gibiansky, Ekaterina Gibiansky, Nicolas Frey, Navita L. Mallalieu, Claire Petry, Jean-Eric Charoin, Min Bao, Christopher Mela, Wendy Douglass, Joy C. Hsu, Bridging from Intravenous to Subcutaneous Formulation of Tocilizumab for Optimal Dose Regimens in Systemic Juvenile Idiopathic Arthritis (sJIA), PAGE-27 Conference (2018) Abstract 8731 of the Annual Meeting of the Population Approach Group in Europe. Abstract Also Abstracts of American Conference on Pharmacometrics (ACoP9), Journal of Pharmacokinetics and Pharmacodynamics, 2018: 45(S1), Abstract T-031, Page S-60.

  • Ekaterina Gibiansky, Neal M Davies, A Population Pharmacokinetic Model of Liposomal Bupivacaine Administered as Single-Dose Nerve Block in Patients Undergoing Various Surgical Procedures, Abstracts of American Conference on Pharmacometrics (ACoP9), Journal of Pharmacokinetics and Pharmacodynamics 2018: 45(S1), Abstract M-048, Page S-25.

  • Xiaohui Wei, Leonid Gibiansky, Yehong Wang, Franklin Fuh, Rich Erickson, Sharon O’Byrne, and Meina T. Tang, Pharmacokinetic and Pharmacodynamic Modeling of Serum Etrolizumab and Circulating beta7 Receptor Occupancy in Patients With Ulcerative Colitis, The Journal of Clinical Pharmacology 58 (3) 386-398 (2018), DOI: 10.1002/jcph.1031 Abstract, Full text

  • Leonid Gibiansky, Ekaterina Gibiansky, Mathematical description of drug–target interactions: application to biologics that bind to targets with two binding sites, Journal of Pharmacokinetics and Pharmacodynamics 45 (1), 23-34, DOI 10.1007/s10928-017-9546-9, Full text for viewing via Springer Nature SharedIt

2017:
  • Candice Jamois, Ekaterina Gibiansky, Leonid Gibiansky, Vincent Buchheit, Pauline Baumlin, Denis Sahin, Guillaume Cartron, Robert Marcus, Wolfgang Hiddemann, John F Seymour, Jonathan C Strefford, Georgina Meneses-Lorente, Nicolas Frey, Günter Fingerle-Rowson, Influence of Baseline Disease Characteristics and Exposure to Obinutuzumab on Clinical Outcome in Patients with Previously Untreated Advanced Follicular Lymphoma Treated with Obinutuzumab-Based Immunochemotherapy in the GALLIUM Trial , Blood (2017) 130 (Supplement 1): 3848. Abstract

  • Dan Lu, Leonid Gibiansky, Sandhya Girish, Priya Agarwal, Chunze Li, Dale Miles, Randall Dere, Jamie Hirata, Yu-Waye Chu, Jin Yan Jin, Integrated Three-Analyte Population Pharmacokinetic (PPK) Model for Antibody-Drug-Conjugates (ADC) in Patients with Non-Hodgkin Lymphoma, American Conference on Pharmacometrics (ACoP7), Fort Lauderdale, FL, October 15-18, 2017, Journal of Pharmacokinetics and Pharmacodynamics (2017), abstract M-028.

  • Kenta Yoshida, Klas Petersson, Jeff Wald, Anders Viberg, Leonid Gibiansky, Leslie Chinn, Angelica Quartino, Two targets TMDD model described nonlinear pharmacokinetics of a bispecific antibody for Fibroblast Growth Factor Receptor 1/Klotho Complex in humans, American Conference on Pharmacometrics (ACoP7), Fort Lauderdale, FL, October 15-18, 2017, Journal of Pharmacokinetics and Pharmacodynamics (2017), abstract T-083.

  • Matts Kågedal, Leonid Gibiansky, Sandhya Girish, Jin Jin, Chunze Li, Investigation of Body-Size-Based Dosing Regimens for vcMMAE Antibody-Drug Conjugates (ADC), American Conference on Pharmacometrics (ACoP7), Fort Lauderdale, FL, October 15-18, 2017, Journal of Pharmacokinetics and Pharmacodynamics (2017), abstract W-004.

  • Leonid Gibiansky, Ekaterina Gibiansky, Nicolas Frey, Navita L. Mallalieu, Claire Petry, Jean-Eric Charoin, Neil Collinson, Joy C. Hsu, Population Pharmacokinetic and Exposure-Efficacy/Safety Analyses for Selection of Optimal Dose Regimen of Tocilizumab in Patients With Giant Cell Arteritis (GCA), American Conference on Pharmacometrics (ACoP7), Fort Lauderdale, FL, October 15-18, 2017, Journal of Pharmacokinetics and Pharmacodynamics (2017), abstract W-076.

  • Leonid Gibiansky, Ekaterina Gibiansky, Nicolas Frey, Navita L. Mallalieu, Claire Petry, Jean-Eric Charoin, Wendy Douglass, Joy C. Hsu, Bridging from Intravenous to Subcutaneous Formulation of Tocilizumab for Optimal Dose Regimens in Polyarticular Juvenile Idiopathic Arthritis (pJIA), American Conference on Pharmacometrics (ACoP7), Fort Lauderdale, FL, October 15-18, 2017, Journal of Pharmacokinetics and Pharmacodynamics (2017), abstract M-028.

  • Aram Oganesian, Leonid Gibiansky, Ekaterina Gibiansky, Hagop M. Kantarjian, Gail J. Roboz, Karen W.L. Yee, Patricia L. Kropf, Mohammad Azab, and Jean-Pierre Issa, Population Pharmacokinetics Analysis for Guadecitabine (SGI-110) and Decitabine after Subcutaneous Dosing with SGI-110 in Patients with Relapsed/Refractory AML and MDS, Poster presented at: 2017 ACCP Annual Meeting, San Diego, CA September 17–19, 2017

  • 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, Platform model describing pharmacokinetic properties of vc-MMAE antibody–drug conjugates, Journal of Pharmacokinetics and Pharmacodynamics (2017), doi:10.1007/s10928-017-9544-y, Abstract, Full text for viewing via Springer Nature SharedIt

  • Chaitali Passey, Johanna Mora, Robert Dodge, Leonid Gibiansky, Jennifer Sheng, Amit Roy, Akintunde Bello, Manish Gupta, An Integrated Assessment of the Effects of Immunogenicity on the Pharmacokinetics, Safety, and Efficacy of Elotuzumab, AAPS J. 2017 Jan 9. doi: 10.1208/s12248-016-0033-9. [Epub ahead of print] Abstract

  • L Gibiansky, Y Wang, F Fuh, NX Wang, A Quartino, R Erickson, T Ramirez-Montagut, MT Tang, Etrolizumab Population PK-PD Modeling: Treatment-Induced Serum sMADCAM-1 Reduction Predicts beta7 Receptor Occupancy in Patients with Ulcerative Colitis Clinical Pharmacology & Therapeutics 101 (S1) S90

  • Leonid Gibiansky, Ekaterina Gibiansky, Target-mediated drug disposition model for drugs with two binding sites that bind to a target with one binding site, Journal of Pharmacokinetics and Pharmacodynamics (2017), DOI 10.1007/s10928-017-9533-1, Full text for viewing via Springer Nature SharedIt

2016:
  • Chunze Li, Priya Agarwal, Ekaterina Gibiansky, Jin Yan Jin, Susan Dent, Anthony Gonçalves, Ihsan Nijem, Alexander Strasak, Marie-Laurence Harle-Yge, Nataliya Chernyukhin, Pat LoRusso, Sandhya Girish, A Phase I Pharmacokinetic Study of Trastuzumab Emtansine (T-DM1) in Patients with Human Epidermal Growth Factor Receptor 2-Positive Metastatic Breast Cancer and Normal or Reduced Hepatic Function, Clin Pharmacokinet (2016). doi:10.1007/s40262-016-0496-y, Abstract

  • Chaitali Passey, Leonid Gibiansky, Jennifer Sheng, Akintunde Bello, Amit Roy, Manish Gupta, Exposure–Response Analysis of Safety of Elotuzumab in Patients With Multiple Myeloma, American Conference on Pharmacometrics (ACoP7), Bellevue, WA, October 23-26, 2016, Journal of Pharmacokinetics and Pharmacodynamics (2016), 43(S), page S85, Abstract T-81

  • Patanjali Ravva, Stefan Sturm, Neil John Parrott, Rajinder Bharadwaj, Barry Clinch, Leonid Gibiansky, Mechanistic Population Pharmacokinetics of Oseltamavir in neonates and up to young adults patients with normal renal function, American Conference on Pharmacometrics (ACoP7), Bellevue, WA, October 23-26, 2015, Journal of Pharmacokinetics and Pharmacodynamics (2016), 43(S), page S75, abstract T-59.

  • Joy C. Hsu, Leonid Gibiansky, Kamal Bharucha, Alysha Kadva, Mohamed Kamal, Navita Mallalieu, Nicolas Frey, Bridging from the Intravenous to Subcutaneous Formulation of Tocilizumab for Polyarticular Juvenile Idiopathic Arthritis and Systemic Juvenile Idiopathic Arthritis by Leveraging Prior Pharmacometrics Knowledge, American Conference on Pharmacometrics (ACoP7), Bellevue, WA, October 23-26, 2015, Journal of Pharmacokinetics and Pharmacodynamics (2016), 43(S), page S104, Abstract W-40

  • D Lu, L Gibiansky, P Agarwal, RC Dere, C Li, Y‐W Chu, J Hirata, A Joshi, JY Jin, S Girish, Integrated Two‐Analyte Population Pharmacokinetic Model for Antibody–Drug Conjugates in Patients: Implications for Reducing Pharmacokinetic Sampling, CPT: Pharmacometrics & System Pharmacology, November 2016, DOI: 10.1002/psp4.12137, Abstract, HTML, PDF

  • Leonid Gibiansky, Matts Kågedal, Jian Xu, Nina Wang, Charles Chen, Sandhya Girish, Jin Jin, Chunze Li, vc-MMAE antibody-drug conjugates: a unified model describes pharmacokinetics of eight different compounds, PAGE 2016 Meeting, Lisbon, Portugal, June 8-10, 2016, Abstract I-21, Poster I-21.

  • Ekaterina Gibiansky, Leonid Gibiansky, Michael Brewster, Candice Jamois, Vincent Buchheit, Nicolas Frey, Population Pharmacokinetic of Obinutuzumab (GA101) in Patients with Chronic Lymphocytic Leukemia (CLL), Follicular Lymphoma (FL), Other Indolent Non-Hodgkin’s Lymphoma (iNHL) Subtypes, Diffuse Large B-cell Lymphoma (DLBCL), and Mantle Cell Lymphoma (MCL), PAGE 2016 Meeting, Lisbon, Portugal, June 8-10, 2016, Abstract I-20, Poster I-20.

  • Leonid Gibiansky, Matts Kågedal, Jian Xu, Nina Wang, Charles Chen, Sandhya Girish, Jin Jin, Chunze Li, Modeling platform to describe pharmacokinetic properties of vc-MMAE antibody-drug conjugates, Poster T-2063, 2016 AAPS National Biotechnology Conference, May 16-18, 2016, Boston, US Abstract,

  • R.H.G.P. Arends, N. Kaila, S.F. Marshall, L. Gibiansky, Translational Modeling of Tanezumab Pharmacokinetics and Tanezumab-NGF Relationship to Predict Free NGF Concentrations in Nonhuman Primates and Humans, Poster T-2064, 2016 AAPS National Biotechnology Conference, May 16-18, 2016, Boston, US Abstract,

  • Chaitali Passey, Leonid Gibiansky, Johanna Mora, Amit Roy, Akintunde Bello, Manish Gupta, Effect of Dexamethasone Co-administration on the Pharmacokinetics and Immunogenicity of Elotuzumab, Poster PII-043, American Society for Clinical Pharmacology and Therapeutics (ASCPT) 2016 Annual Meeting; March 8–12, 2016; San Diego, CA, J. Clinical Pharmacology and Therapeutics, 99: S86

  • Priya Agarwal, Chunze Li, Ekaterina Gibiansky, Susan Dent, Anthony Gonçalves, Ihsan Nijem, Alexander Strasak, Marie-Laurence Harle-Yge, Pat LoRusso, Sandhya Girish, Phase 1 study of trastuzumab emtansine (T-DM1) in HER2-positive metastatic breast cancer (MBC) patients with normal or reduced hepatic function, Poster E-002, American Society for Clinical Pharmacology and Therapeutics (ASCPT) 2016 Annual Meeting; March 8–12, 2016; San Diego, CA, J. Clinical Pharmacology and Therapeutics, 99: S21

  • Leonid Gibiansky , Chaitali Passey , Amit Roy, Akintunde Bello, Manish Gupta, Model-based pharmacokinetic analysis of elotuzumab in patients with relapsed/refractory multiple myeloma, Journal of Pharmacokinetics and Pharmacodynamics, June 2016, Volume 43, Issue 3, pp 243-257, doi:10.​1007/​s10928-016-9469-x, Abstract

2015:
  • Dan Lu, Jin Yan Jin, Leonid Gibiansky, William R Gillespie, Priya Agarwal, Cheryl Jones, Yu-Waye Chu, Michael K Wenger, Jamie Hirata, Chunze Li, Sandhya Girish, Exposure-Response Analysis to Assist Selection of Dose and Treatment Duration for Polatuzumab Vedotin As a Single Agent or in Combination with Rituximab for the Treatment of B-Cell Lymphoma, Poster at 57th ASH Annual Meeting and Exposition (December 5-8, 2015). Blood, 126 (23): 1525, Abstract

  • Leonid Gibiansky, Ekaterina Gibiansky, The Relationship between Target-Mediated Drug Disposition (TMDD) and Models with Time-Dependent Clearance, Increasing Drug Development Success: Understanding Drug-Disease Interactions Through Quantitative Systems Pharmacology, November 2-3, 2015, New York City, USA, Abstract, Poster

  • KN Le, L Gibiansky, M van Lookeren Campagne, J Good, T Davancaze, KM Loyet, A Morimoto, EC Strauss and JY Jin, Population Pharmacokinetics and Pharmacodynamics of Lampalizumab Administered Intravitreally to Patients With Geographic Atrophy, CPT: Pharmacometrics & Systems Pharmacology (December 58, 2015),DOI: 10.1002/psp4.12031, Abstract, Full text.

  • Jian Xu, Leonid Gibiansky, Jonathan Squire, Xin Wang, Sandhya Girish, Jin Jin, Development of a Mega Population Pharmacokinetic (PK) Model of Genentech Antibody-Drug conjugate (ADC) Platform, American Conference on Pharmacometrics (ACoP6), Crystal City, VA, October 4-7, 2015, Journal of Pharmacokinetics and Pharmacodynamics (2015), 42(S), page S98, abstract W-53.

  • Leonid Gibiansky, Chaitali Passey, Amit Roy, Akintunde Bello, Manish Gupta, Model-Based Analysis to Support Clinical Pharmacology Profiling of Elotuzumab in Patients with Multiple Myeloma, American Conference on Pharmacometrics (ACoP6), Crystal City, VA, October 4-7, 2015, Journal of Pharmacokinetics and Pharmacodynamics (2015), 42(S), page S40, abstract M-68.

  • Chaitali Passey, Leonid Gibiansky, Amit Roy, Akintunde Bello, Manish Gupta, Latent Variable Approach to Assess the Time-Varying Effect of Immunogenicity on the Pharmacokinetics of Elotuzumab in Patients with Multiple Myeloma, American Conference on Pharmacometrics (ACoP6), Crystal City, VA, October 4-7, 2015, Journal of Pharmacokinetics and Pharmacodynamics (2015), 42(S), page S71, abstract T-65.

  • Leonid Gibiansky, Ekaterina Gibiansky, Target-Mediated Drug Disposition (TMDD) Equations and Approximations for Systems with 1:2 and 2:1 Drug-Target Binding Stoichiometry, American Conference on Pharmacometrics (ACoP6), Crystal City, VA, October 4-7, 2015, Journal of Pharmacokinetics and Pharmacodynamics (2015), 42(S), page S77, abstract W-09. Poster

  • Kha N Le, Leonid Gibiansky, Jeremy Good, Teresa Davancaze, Menno van Lookeren Campagne, Kelly M Loyet, Alyssa Morimoto, Jin Jin, Lisa A Damico-Beyer, and WIlliam D Hanley A Mechanistic PK/PD Model of Factor D Inhibition in Cynomolgus Monkeys by Lampalizumab for the Treatment of Geographic Atrophy, J Pharmacol Exp Ther jpet.115.227223; published ahead of print September 10, 2015, doi:10.1124/jpet.115.227223 Abstract, Full text.

  • Kamal MA, Lien KY, Robson R, Subramoney V, Clinch B, Rayner CR, Gibiansky L. Investigating Clinically Adequate Concentrations of Oseltamivir Carboxylate in End Stage Renal Disease Patients Undergoing Hemodialysis Using a Population Pharmacokinetic Approach, Antimicrob Agents Chemother. 2015 Nov;59(11):6774-81. doi: 10.1128/AAC.01024-15. Epub 2015 Aug 17., Abstract.

  • Leonid Gibiansky, Mylène Giraudon, Craig R. Rayner, Barbara J. Brennan, Vishak Subramoney, Richard Robson, Mohamed A. Kamal, Population pharmacokinetic analysis of oseltamivir and oseltamivir carboxylate following intravenous and oral administration to patients with and without renal impairment, Journal of Pharmacokinetics and Pharmacodynamics, March, 2015, DOI 10.1007/s10928-015-9411-7, Abstract.

  • D Lu, JY Jin, L Gibiansky, P Agarwal, R Dere, C Jones, C Li, M Wenger, Y Chu, R Kahn, A Joshi, S Girish, Population Pharmacokinetics and Exposure-Response Assessment of Anti-CD79B antibody-Drug Conjugate in Patients: Interim Analysis Results, ASCPT 2015 Meeting, New Orleans, LA, March 3-7, 2015, Abstract PI-095.

  • Leonid Gibiansky, Ekaterina Gibiansky, Approximations of the Target-Mediated Drug Disposition (TMDD) Equations for Systems with 1:2 and 2:1 Drug-Target Binding Stoichiometry, PAGE 2015 Meeting, Hersonissos, Crete, Greece, June 2-5, 2015, Abstract III-21, Poster III-21.

  • Ekaterina Gibiansky, Michael Brewster, Clarisse Chavanne, Nicolas Frey, and Candice Jamois, Comparison of Population Pharmacokinetics and Exposure-Response Relationships of Intravenous Rituximab and Subcutaneous Rituxumab in Patients with Chronic Lymphocytic Leukemia, PAGE 2015 Meeting, Hersonissos, Crete, Greece, June 2-5, 2015, Abstract III-22, Poster III-22.

2014:
  • Leonid Gibiansky, Ekaterina Gibiansky, Approaches to Modeling Clinical PK of ADCs, Session 4b: PKPD Modeling of Antibody-Drug Conjugate (Symposium) at ACoP Annual Meeting, Las Vegas, Nevada, October 12–15, 2014: Slides.

  • Ekaterina Gibiansky, Leonid Gibiansky, David Carlile, Candice Jamois, Vincent Buchheit, Nicolas Frey, Population Pharmacokinetics of Obinutuzumab (GA101) in Chronic Lymphocytic Leukemia (CLL) and Non-Hodgkin's Lymphoma and Exposure-Responses in CLL, CPT Pharmacometrics Syst. Pharmacol. (2014) 3, e144; doi:10.1038/psp.2014.42 html, pdf

  • Leonid Gibiansky, Nicolas Frey, Joy C. Hsu, Effects of Tocilizumab on DAS28 in Patients with Rheumatoid Arthritis (RA), ACoP Annual Meeting, Las Vegas, Nevada, October 12–15, 2014: Abstract, Poster.

  • Leonid Gibiansky, Nicolas Frey, Joy C. Hsu, Effects of Tocilizumab on Neutrophil Counts in Patients with Rheumatoid Arthritis (RA), presented at ACoP Annual Meeting, Las Vegas, Nevada, October 12–15, 2014: Abstract, Poster.

  • Leonid Gibiansky, Nicolas Frey, Joy C. Hsu, Population Pharmacokinetics (PK) of Tocilizumab Following Intravenous (IV) and Subcutaneous (SC) Administration to Patients with Rheumatoid Arthritis (RA), ACoP Annual Meeting, Las Vegas, Nevada, October 12–15, 2014: Abstract. Poster.

  • Dan Lu, Leonid Gibiansky, Jin Yan Jin, Priya Agarwal, Chunze Li, Rong Zhang, Randell C. Dere, Yu-Waye Chu, Sandhya Girish, Integrated Pharmacokinetic Model for Antibody-Drug-Conjugate (ADC) in Patients with B-cell Malignancy: Implications for Optimal Sampling, ACoP Annual Meeting, Las Vegas, Nevada, October 12–15, 2014: Abstract.

  • Ekaterina Gibiansky, Leonid Gibiansky, David Carlile, Candice Jamois, Vincent Buchheit, Nicolas Frey, Population Pharmacokinetics of Obinutuzumab (GA101) in Patients with Chronic Lymphocytic Leukemia (CLL) and Non-Hodgkin’s Lymphoma (NHL), ACoP Annual Meeting, Las Vegas, Nevada, October 12–15, 2014: Abstract. Poster.

  • Leonid Gibiansky, Richard Robson, Vishak Subramoney, Mohamed A. Kamal, Population Pharmacokinetics (PPK) and Optimal Dosing of Oseltamivir in Patients with End Stage Renal Disease (ESRD) on Hemodialysis (HD), ACoP Annual Meeting, Las Vegas, Nevada, October 12–15, 2014: Abstract. Poster.

  • Leonid Gibiansky, Mylène Giraudon, Craig R. Rayner, Barbara Brennan, Vishak Subramoney, Richard Robson, Mohamed A. Kamal, Population Pharmacokinetics (PPK) and Optimal Dosing of Oseltamivir Administered IV and Orally to Healthy Subjects and Subjects with Renal Impairment, ACoP Annual Meeting, Las Vegas, Nevada, October 12–15, 2014: Abstract. Poster.

  • Leonid Gibiansky, Ekaterina Gibiansky, Numerical Testing of Assumptions for Target-Mediated Drug Disposition (TMDD) Equations: Why Inexact Model Provides Satisfactory Description? PAGE 2014 Meeting, Alicante, Spain, June 10-13, 2014: Abstract I-14, Poster.

  • Ekaterina Gibiansky, Leonid Gibiansky, David Carlile, Candice Jamois, Vincent Buchheit, Nicolas Frey, Population Pharmacokinetic of Obinutuzumab (GA101) in Patients with Chronic Lymphocytic Leukemia (CLL) and Non-Hodgkin’s Lymphoma (NHL), PAGE 2014 Meeting, Alicante, Spain, June 10-13, 2014: Abstract I-15, Poster.

  • Kha N Le, Leonid Gibiansky, Erich Strauss, Zhengrong Li, Menno van Lookeren, Brian Yaspan, Jin Jin, Jennifer Visich, Population PKPD Modeling of Geographic Atrophy Disease Progression, Target Mediated Disposition and Treatment Effect of Lampalizumab, PAGE 2014 Meeting, Alicante, Spain, June 10-13, 2014 Abstract.

  • Kha N Le, L Gibiansky, J Good, T Davancaze, A Morimoto, K Loyet, M Campagne, E Strauss, R Graham, J Jin, J Visich, Selection of Dosing Regimen Using a PK-PD Model Incorporation Target Mediated Drug Disposition (TMDD) of Lampalizumab (LPZ) in Geographic Atrophy (GA) Patients, ASCPT 2014, Clinical Pharmacology & Therapeutics, 95: S49-S50 Abstract PI-097.

  • Leonid Gibiansky, Ekaterina Gibiansky, Why Standard Target-Mediated Drug Disposition (TMDD) Models Describe Observed Data: Testing Sensitivity to Model Assumptions, AAPS National Biotechnology Conference 2014, San Diego, CA, US. Abstract, Poster.

  • Ellen Q. Wang, David R. Plowchalk, Leonid Gibiansky, Kevin R. Sweeney, Nitin Kaila, Population Pharmacokinetic and Pharmacodynamic Modeling of Bococizumab (RN316/PF-04950615) in Hypercholesterolemic Subjects, 82d Congress of European Atherosclerosis Society 2014, Madrid, Spain. Abstract EAS-1003

  • MA Kamal, EP Acosta, DW Kimberlin, L Gibiansky, P Jester, V Niranjan, B Rath, B Clinch, PJ Sánchez, K Ampofo, R Whitley and CR Rayner, The Posology of Oseltamivir in Infants with Influenza Infection Using a Population Pharmacokinetic Approach, Clinical Pharmacology & Therapeutics, 2014, doi: 10.1038/clpt.2014.120 Abstract

  • Leonid Gibiansky, Ekaterina Gibiansky,Valerie Cosson, Nicolas Frey, Franziska Schaedeli Stark, Methods to Detect Non-Compliance and Reduce its Impact on Population PK Parameter Estimates, Journal of Pharmacokinetics and Pharmacodynamics, 2014, 41(3):279-289, doi:10.1007/s10928-014-9364-2, Abstract

  • D Ouellet, E Gibiansky, C Leonowens, A O’Hagan, P Haney, JC Switzky, VL Goodman, Population Pharmacokinetics of Dabrafenib, a BRAF Inhibitor: Effect of Dose, Time, Covariates and Relationship with its Metabolites, J Clin Pharmacol. 2014 Jan 9. doi: 10.1002/jcph.263. Abstract

  • April M. Barbour, Leonid Gibiansky, and Mary Beth Wire, Population pharmacokinetic modeling and simulation of amprenavir following fosamprenavir/ritonavir administration for dose optimization in HIV infected pediatric patients, J Clin Pharmacol 2014 54(2), 206–214, Abstract.

2013:
  • Leonid Gibiansky, Ekaterina Gibiansky, Target-Mediated Drug Disposition Model and its Approximations for Antibody-Drug Conjugates, Journal of Pharmacokinetics and Pharmacodynamics, 2013, Abstract.

  • Mohamed Kamal, Edward Acosta, David Kimberlin, Leonid Gibiansky, Penelope Jester, Vis Niranjan, Barbara Rath, Barry Clinch, Pablo Sánchez, Krow Ampofo, Richard Whitley, Craig R Rayner, Population pharmacokinetics define dosing recommendations of oseltamivir in neonates and infants with influenza, Poster 4995, at Options for the Control of Influenza VIII, Cape Town, South Africa, 5–10 September 2013.

  • Leonid Gibiansky, Ekaterina Gibiansky, Mechanistic PK Modeling Approaches for Antibody Drug Conjugates (November 10, 2013, Short Course 3: Mechanistic PKPD to Overcome Translational Considerations for Antibody Drug Conjugates (ADC) and THIOMABs (TDCS)—Nonclinical to First in Human and Beyond), Short Course at AAPS Annual Meeting, San Antonio, 2013.

  • Leonid Gibiansky, Ekaterina Gibiansky, Pharmacokinetics of Antibody-Drug Conjugates (ADC): Simplification of Equations and Model-Independent Assessment of Deconjugation Rate, AAPS Annual Meeting, San Antonio, 2013. Abstract, Poster

  • Ekaterina Gibiansky, Robert Bauer, Leonid Gibiansky, Confidence Intervals for Variability Estimates of Mixed-Effect Models, AAPS Annual Meeting, San Antonio, 2013. Abstract, Poster

  • Holly Kimko, Leonid Gibiansky, Iolanda Cirillo, Marin Kollef, Rebecca Redman, Alfred Tonelli, Partha Nandy, Assessment Of The Effectiveness Of A Short 7-Day Course Of Doripenem In Ventilator-Associated Pneumonia Via Pharmacokinetic-Pharmacodynamic Modeling, American Thoracic Society International Conference 2013, Chapter DOI: 10.1164/ajrccm-conference.2013.187.1_MeetingAbstracts.A3238 Abstract

  • Siobhan Hayes, Paul N. Mudd Jr., Daniele Ouellet , Brendan M. Johnson , Daphne Williams, Ekaterina Gibiansky, Population PK/PD modeling of eltrombopag in subjects with advanced solid tumors with chemotherapy-induced thrombocytopenia, Cancer Chemotherapy and Pharmacology, 2013, 71(6): 1507-1520, doi: 10.1007/s00280-013-2150-9, Abstract

  • Leonid Gibiansky, Ekaterina Gibiansky, Valerie Cosson, Nicolas Frey, Franziska Schaedeli Stark, Approaches to Detect Non-Compliant Patients and Obtain Unbiased Estimates of Population PK Model Parameters in a Population with Prevalent Non-Compliance, ACoP 2013 Meeting, Fort Lauderdale, May 12-15, 2013 Abstract, Poster.

  • Leonid Gibiansky, Ekaterina Gibiansky, Detection of Immunogenicity and Unbiased Estimation of Model Parameters for Monoclonal Antibodies, ACoP 2013 Meeting, Fort Lauderdale, May 12-15, 2013 Abstract, Poster.

  • Leonid Gibiansky, Ekaterina Gibiansky, Immunogenicity in PK of Monoclonal Antibodies: Detection and Unbiased Estimation of Model Parameters, PAGE 2013 Meeting, Glasgow, Scotland, June 11-14, 2013 Abstract II-22, Poster.

  • Leonid Gibiansky, Ekaterina Gibiansky, Monoclonal Antibody-Drug Conjugates (ADC): Simplification of Equations and Model-Independent Assessment of Deconjugation Rate, PAGE 2013 Meeting, Glasgow, Scotland, June 11-14, 2013 Abstract II-23, Poster.

  • Leonid Gibiansky, Ekaterina Gibiansky, Valerie Cosson, Nicolas Frey, Franziska Schaedeli Stark, Methods to Detect Non-Compliance and Minimize its Impact on Population PK Parameter Estimates, PAGE 2013 Meeting, Glasgow, Scotland, June 11-14, 2013 Abstract A-31, Slides of the talk.

  • E Gibiansky, A O’Hagan, P Haney, JC Switzky, VL Goodman, D Ouellet, Population Pharmacokinetics of Dabrafeninb (GSK2118436), a BRAF in Development for the Treatment of BRAF V600 Mutation Positive Melanoma, ASCPT Annual Meeting, Indianapolis, 2013. Poster

2012:
  • Timothy T Bergsma, William Knebel, Jeannine Fisher, William R Gillespie, Matthew M Riggs, Leonid Gibiansky, Marc R Gastonguay, Facilitating pharmacometric workflow with the metrumrg package for R, Computer methods and programs in biomedicine, 2012 Sep 28. pii: S0169-2607(12)00191-5. doi: 10.1016/j.cmpb.2012.08.009. [Epub ahead of print], Abstract.

  • Leonid Gibiansky and Ekaterina Gibiansky, Pharmacokinetics of Antibody-Drug Conjugates: TMDD Equations, Approximations, and Identifiability of Model Parameters, AAPS Annual Meeting, Chicago, 2012, Abstract W5345, Poster.

  • Leonid Gibiansky, Olivier Harari and Nicholas Frey, Immediate and Long-Term Effects of Tocilizumab on Neutrophil Counts in Pediatric Patients with Systemic Juvenile Idiopathic Arthritis, AAPS Annual Meeting, Chicago, 2012, Abstract W5344, Poster.

  • Siobhan Hayes, Paul N Mudd Jr, Daniele Ouellet, Ekaterina Gibiansky, PK/PD modeling and optimization of eltrombopag dose and regimen for treatment of chemotherapy-induced thrombocytopenia (CIT) in cancer patients, 2012 PAGE Meeting, Venice, Italy. Abstract.

  • Leonid Gibiansky and Ekaterina Gibiansky, Monoclonal Antibody-Drug Conjugates (ADC): TMDD Equations, Approximations, and Identifiability of Model Parameters, 2012 PAGE Meeting, Venice, Italy. Abstract, Poster.

  • Nicholas Frey, Olivier Harari and Leonid Gibiansky, Short- and Long-Term Effects of Tocilizumab on Neutrophil Counts in Pediatric Patients with Systemic Juvenile Idiopathic Arthritis, 2012 PAGE Meeting, Venice, Italy. Abstract, Poster.

  • Leonid Gibiansky, Ekaterina Gibiansky, Bioavailability of Drugs with Nonlinear Pharmacokinetics (PK) Can be Approximated by the Ratio of Doses that Provide Equal Areas under the Concentration-Time Curves (AUCs), AAPS National Biotechnology Conference, San Diego, 2012, Abstract, Poster.

  • Leonid Gibiansky, TMDD Model and its Application in the Early Clinical Development of Antibody Therapeutics, AAPS National Biotechnology Conference Sunrise session, San Diego, 2012, Abstract, Slides.

  • Florence Hourcade-Potelleret, Leonid Gibiansky, Use of a TMDD Model to Support Dose Selection: GA101 Example, ASCPT Annual Metting, National Harbor, Maryland, 2012, Slides.

  • Holly Kimko, Ekaterina Gibiansky, Leonid Gibiansky, H. Lynn Starr, Joris Berwaerts, Joseph Massarella and Frank Wiegand, Population pharmacodynamic modeling of various extended-release formulations of methylphenidate in children with attention deficit hyperactivity disorder via meta-analysis, Journal of Pharmacokinetics and Pharmacodynamics, (2011), DOI: 10.1007/s10928-011-9238-9. Abstract.

2011:
  • Leonid Gibiansky, Ekaterina Gibiansky, Robert Bauer, Comparison of Nonmem 7.2 Estimation Methods and Parallel Processing Efficiency on a Target-Mediated Drug Disposition Model, Journal of Pharmacokinetics and Pharmacodynamics, (2011), DOI: 10.1007/s10928-011-9228-y. Abstract.

  • Leonid Gibiansky, Nicolas Frey, Linking interleukin 6 receptor blockade with tocilizumab and its hematological effects using a modeling approach, Journal of Pharmacokinetics and Pharmacodynamics, (2011), DOI: 10.1007/s10928-011-9227-z. Abstract.

  • Leonid Gibiansky, Liviawati Sutjandra, Sameer Doshi, Jenny Zheng, Winnie Sohn, Mark C. Peterson, Graham R. Jang, Andrew T. Chow, Juan Jose Perez Ruixo, Population Pharmacokinetics Analysis of Denosumab in Patients with Bone Metastases from Solid Tumors, Clinical Pharmacokinetics, 2012 Apr 1;51(4):247-60. doi: 10.2165/11598090-000000000-00000.

  • Leonid Gibiansky, PK-PD Modeling of Monoclonal Antibodies and other Biologics using Target-Mediated Drug Disposition Model, Sunrise Session "Therapeutic Protein Pharmacokinetics and Pharmacodynamics", 7:00 - 08:15 am Tuesday, October 25, 2011, AAPS Annual Meeting, Washington, DC, US.

  • Tarundeep Kakkar, Cynthia Sung, Leonid Gibiansky, Thuy Vu, Adimoolam Narayanan, Shao-Lee Lin, Michael Vincent, Christopher Banfield, Alex Colbert, Sarah Hoofring, Marta Starcevic, Peiming Ma, Population PK and IgE Pharmacodynamic Analysis of a Fully Human Monoclonal Antibody Against IL4 Receptor, Pharm Res, 2011, DOI: 10.1007/s11095-011-0481-y, Abstract.

  • Ekaterina Gibiansky, Jianping Zhang, Daphne Williams, Zhao Wang, Daniele Ouellet, Population Pharmacokinetics of Eltrombopag in Healthy Subjects and Patients with Chronic Idiopathic Thrombocytopenic Purpura, Journal of Clinical Pharmacology, 2011, 51:842-856, DOI: 10.1177/0091270010375427, Abstract.

  • Holly Kimko, Ekaterina Gibiansky, Leonid Gibiansky, H. Lynn Starr, Joris Berwaerts, Joseph Massarella, Robert Armstrong, Frank Wiegand, Disease-Drug Model of Methylphenidate (MPH) in Children with Attention Deficit Hyperactivity Disorder Via Longitudinal Meta-analysis, 2011 PAGE Meeting, Athens, Greece. Abstract.

  • Leonid Gibiansky and Nicolas Frey, Mechanistic Modeling of the Link between Interleukin 6 Receptor Blockade with Tocilizumab and Its Hematological Effects, 2011 PAGE Meeting, Athens, Greece. Abstract.

  • Leonid Gibiansky, Modeling of Drugs with Target-Mediated Disposition, Invited Talk at 2011 PAGE Meeting, Athens, Greece. Abstract. Slides.

  • Bipin Mistry, Leonid Gibianky and Ziad Hussein, Population pharmacokinetic modelling of decitabine in patients with myelodysplastic syndromes (MDS) and acute myeloid leukemia (AML), 2011 ASCO Annual Meeting,Chicago, US. Journal of Clinical Oncology 2011 29:15_suppl, 6551-6551, DOI: jco.2011.29.15_suppl.6551. Abstract.

  • Leonid Gibiansky, Application of TMDD-model Approximations to Biologics: Why, When and How, roundtable "Identifiability and Applicability of Target Mediated Drug Disposition Model for Biologics", AAPS National Biotechnology Conference 2011, San Francisco, CA, US.

  • Scott E Evans, Michael J Tuvim, Cory J Fox, Nidhi Sachdev,Leonid Gibiansky and Burton F Dickey, Inhaled innate immune ligands to prevent pneumonia, British Journal of Pharmacology (2011) 163 195–206: Abstract.

  • Holly Kimko, Ekaterina Gibiansky, Leonid Gibiansky, H. Lynn Starr, Joris Berwaerts, Joseph Massarella, Robert Armstrong, Frank Wiegand, Population Disease-Drug Model of Methylphenidate in Children with Attention Deficit Hyperactivity Disorder Via Model-Based Meta-analysis, ACoP, San Diego, CA, 2011: Abstract.

  • Leonid Gibiansky, Liviawati Sutjandra, Sameer Doshi, Jenny Zheng, Winnie Sohn, Mark Peterson, Graham Jang, Andrew Chow, Juan Jose Perez Ruixo, Population Pharmacokinetic Analysis of Denosumab in Advanced Cancer Patients with Solid Tumors, ACoP, San Diego, CA, 2011, Abstract.

2010:
  • Leonid Gibiansky, Ekaterina Gibiansky, Bipin Mistry, Population Pharmacokinetic and Pharmacodynamic Modeling of Fospropofol Injection in Patients, American Society of Anesthesiologists Annual Meeting, San Diego, CA, 2010: Abstract A876.

  • Leonid Gibiansky, Ekaterina Gibiansky, Target-Mediated Drug Disposition Model for Drugs That Bind to More than One Target, Journal of Pharmacokinetics and Pharmacodynamics, (2010) 37(4): 323-346, DOI: 10.1007/s10928-010-9163-3, Abstract.

  • Siobhan Hayes, Daniele Ouellet, Jianping Zhang, Mary Wire, Ekaterina Gibiansky, Population PK/PD Modeling of Eltrombopag in Healthy Volunteers and Patients with Immune Thrombocytopenic Purpura and Optimization of Response-Guided Dosing, Journal of Clinical Pharmacology, 2010, DOI: 10.1177/0091270010383019 Abstract.

  • Leonid Gibiansky, Ekaterina Gibiansky, Modeling of Drugs with Soluble (S) and Membrane-Bound (M) Targets using Quasi-Steady-State (QSS) Approximation of the Target-Mediated Drug Disposition (TMDD) Model, AAPS National Biotechnology Conference, San Francisco, 2010, Abstract, Poster.

  • Leonid Gibiansky, Ekaterina Gibiansky, Irreversible Binding (IB) and Michaelis-Menten (MM) Approximations of the Target-Mediated Drug Disposition (TMDD) Model, AAPS National Biotechnology Conference, San Francisco, 2010, Abstract, Poster.

  • Leonid Gibiansky, Ekaterina Gibiansky, TMDD Model for Drugs that Bind Soluble and Membrane-Bound Targets: Can Quasi-Steady-State Approximation Estimate Unobservable Membrane-Bound Target Occupancy?, PAGE 19 (2010) Abstract 1941 [www.page-meeting.org/?abstract=1941], Abstract, Poster.

  • Leonid Gibiansky, Ekaterina Gibiansky, Bias and Precision of Parameter Estimates: Comparison of Nonmem 7 Estimation Methods and PFIM 3.2 Predictions on the Example of Quasi-Steady-State Approximation of the Two-Target Target-Mediated Drug Disposition Model, PAGE 19 (2010) Abstract 1727 [www.page-meeting.org/?abstract=1727], Abstract, Poster.

  • M. Campioni, S. Krösser, M.M. Thapar, S.C. Hayes, E. Gibiansky, V. Lucini, R. Anand, Population Pharmacokinetics of Safinamide and its Effect on Disease Progression in Parkinson's Disease, PAGE 19 (2010) Abstract 1827 [www.page-meeting.org/?abstract=1827], Abstract.

  • Leonid Gibiansky, Ekaterina Gibiansky, Target-Mediated Drug Disposition: New Derivation of the Michaelis-Menten Model, and Why It Is Often Sufficient for Description of Drugs with TMDD, PAGE 19 (2010) Abstract 1728 [www.page-meeting.org/?abstract=1728], Abstract, Poster.

2009:
  • Yvonne Y. Lau, Peiming Ma, Leonid Gibiansky, Renee Komorowski, Jin Wang, George Wang, Hai Yan, Murielle M. Véniant and Tarundeep Kakkar, Pharmacokinetic and Pharmacodynamic Modeling of a Monoclonal Antibody Antagonist of Glucagon Receptor in Male ob/ob Mice, The AAPS Journal, 10.1208/s12248-009-9150-z, 2009, DOI, Abstract.

  • Leonid Gibiansky, Ekaterina Gibiansky, Target-Mediated Drug Disposition Model for Drugs with Multiple Targets, ACoP 2009 Abstract, Poster.

  • Leonid Gibiansky, Ekaterina Gibiansky, Mechanistic Interpretation of Indirect-Response Models for Drugs with Target-Mediated Disposition, ACoP 2009 Abstract, Poster.

  • Siobhan Hayes, Daniele Ouellet, Jianping Zhang, Mary Wire, Ekaterina Gibiansky, Semi-Physiological Population PK/PD Modeling of Eltrombopag in Healthy Volunteers and Patients with Idiopathic Thrombocytopenic Purpura, ACoP 2009 Abstract, Poster.

  • Leonid Gibiansky, Ekaterina Gibiansky, Target-Mediated Drug Disposition Model: Relationships with Indirect Response Models and Application to Population PK-PD Analysis, Journal of Pharmacokinetics and Pharmacodynamics (2009),36(4): 341-351, Abstract.

  • Ekaterina Gibiansky, Paul Mudd Jr, Yasser Kamel, Population Pharmacokinetics of Eltrombopag in Patients with Cancer and Healthy Subjects, AAPS Annual Meeting (2009). Abstract, Poster.

  • Leonid Gibiansky, Ekaterina Gibiansky, Target-Mediated Drug Disposition (TMDD): Indirect-Response Models Can Be Used to Estimate Unobservable Unbound Target Concentrations, AAPS Annual Meeting (2009) Abstract, Poster.

  • Tarundeep Kakkar, Leonid Gibiansky, Peiming Ma, Population Pharmacokinetics of AMG 317, a Fully Human Anti-IL-4Rα IgG2 Monoclonal Antibody Evaluated in Healthy and Asthmatic Subjects, AAPS Annual Meeting (2009), Abstract and Poster.

  • Leonid Gibiansky, Ekaterina Gibiansky, Target-Mediated Drug Disposition Model: Approximations, Identifiability of Model Parameters, and Applications to the Population Pharmacokinetic – Pharmacodynamic Modeling of Biologics, Expert Opinion On Drug Metabolism and Toxicology, 5(7): 803-812, 2009. Abstract

  • Leonid Gibiansky, Ekaterina Gibiansky, Pharmacodynamic Modeling of Biologics with Target-Mediated Drug Disposition: TMDD Approximations, Relation to Indirect-Response Models, and Application to Population PK-PD Analyses, PAGE 18 (2009) Abstract 1478 [www.page-meeting.org/?abstract=1478], Abstract and Poster.

  • Ekaterina Gibiansky, Jianping Zhang , Daphne Williams, Zhao Wang, Daniele Ouellet, Population Pharmacokinetics of Eltrombopag in Healthy Subjects and Patients with Chronic Idiopathic Thrombocytopenic Purpura, PAGE 18 (2009) Abstract 1502 [www.page-meeting.org/?abstract=1502], Abstract and Poster.

  • Siobhan Hayes, Daniele Ouellet, Jianping Zhang, Mary Wire, Ekaterina Gibiansky, Population PK/PD Modeling of Eltrombopag in ITP Patients and Optimization of Response-Guided Dosing, PAGE 18 (2009) Abstract 1542 [www.page-meeting.org/?abstract=1542], Abstract and Poster.

  • Leonid Gibiansky, Tarundeep Kakkar, Peiming Ma, Population Pharmacokinetics of AMG 317, a Fully Human Anti-IL-4Rα IgG2 Monoclonal Antibody Evaluated in Healthy and Asthmatic Subjects, PAGE 18 (2009) Abstract 1527 [www.page-meeting.org/?abstract=1527], Abstract and Poster.

2008:
  • Leonid Gibiansky, Ekaterina Gibiansky, Tarundeep Kakkar and Peiming Ma, Approximations of the target-mediated drug disposition model and identifiability of model parameters, Journal of Pharmacokinetics and Pharmacodynamics, 35(5), 2008, page 573. Abstract.

  • Leonid Gibiansky, Parameter Estimates of Population Models: Comparison of Nonmem Versions and Estimation Methods, PAGE 17 (2008) Abstract 1268 [www.page-meeting.org/?abstract=1268], Abstract and Poster.

  • Leonid Gibiansky, Ekaterina Gibiansky,Tarundeep Kakkar, Peiming Ma, Approximations of the Target-Mediated Drug Disposition Model and Identifiability of Model Parameters, PAGE 17 (2008) Abstract 1269 [www.page-meeting.org/?abstract=1269], Abstract and Poster.

  • Leonid Gibiansky, Tarundeep Kakkar, Peiming Ma, Application of Identifiability Analysis Algorithm to Population PK of the Drug with Target-Mediated Drug Disposition, PAGE 17 (2008) Abstract 1271 [www.page-meeting.org/?abstract=1271], Abstract and Poster.

  • L. Zhao, G. Robbie, D. Jackson, J. Gooya, M. Camara, E. Gibiansky. Population Modeling of Tumor Growth in a Murine Xenograft Model Following Administration of Biologic Drug Candidate. American Conference on Pharmacometrics (2008). Abstract and Poster.

  • W. Busse, R. Katial, N. Molfino, S. Miller, E. Gibiansky, A. Coyle, G. Spitalny, M. Koike, A. Wheeler, N. Hanai, B. White. Safety Profile, Pharmacokinetics and Biologic Activity of a Single IV Dose of the Anti-IL5 Receptor Alpha Antibody MEDI-563 in Patients with Mild Asthma. American Journal of Respiratory and Critical Care Medicine, 177: A569 (2008)

  • W. Busse, R. Katial, B. White, E. Gibiansky, A. Coyle, G. Spitalny, N. Molfino. A phase I single escalating intravenous (IV) dose of MEDI 563, an anti-IL5Rα antibody, in atopic asthma. European Respiratory Journal supplement (2008)

  • Ekaterina Gibiansky, Leonid Gibiansky, Indirect Response Models with Positive Feedback: Equations, Properties, and Possible Applications, PAGE 17 (2008) Abstract 1336 [www.page-meeting.org/?abstract=1336], Abstract and Poster.

  • John T. Mondick, Leonid Gibiansky, Marc R. Gastonguay, Jeffrey M. Skolnik, Michael Cole, Gareth J. Veal, Alan V. Boddy, Peter C. Adamson, and Jeffrey S. Barrett, Population Pharmacokinetic Investigation of Actinomycin-D in Children and Young Adults, Journal of Clinical Pharmacology 2008 48: 35. Abstract

  • Leonid Gibiansky, Marc R. Gastonguay, Ajit Shah, Simultaneous Population Pharmacokinetic-Pharmacodynamic Modeling of Fospropofol Injection (Propofol Prodrug) and Propofol Emulsion in Healthy Volunteers, Abstract 4 , American Conference on Pharmacometrics, Tucson, AZ 2008.

  • William Knebel, Tim Bergsma, Jeannine Fisher, George Georgalis, Leonid Gibiansky, Bill Gillespie, Matt Riggs, and Marc R. Gastonguay, Facilitating the Pharmacometrics Work-Flow with the MItools R Package, Abstract 30 , American Conference on Pharmacometrics, Tucson, AZ 2008.

  • Jeannine Fisher, Marc R. Gastonguay, William Knebel, Leonid Gibiansky, Mary Beth Wire, Population Pharmacokinetic Modeling of Fosamprenavir in Pediatric HIV-Infected Patients, Abstract 48 , American Conference on Pharmacometrics, Tucson, AZ 2008.

2007:
  • Ajit Shah, Leonid Gibiansky, Fospropofol Intravenous Injection for Procedural Sedation: A Population Pharmacokinetic Model, 2007 Annual Meeting of American Society of Anesthesiologists. Abstract

  • E. Gibiansky, J. Janik, D. Mahony, K. Kaucic, L. Hammershaimb, G. Robbie. Population Pharmacokinetics of Siplizumab (MEDI-507): Implications for Dosing. PAGE 16 (2007) Abstract 1159 [www.page-meeting.org/?abstract=1159] Abstract, Poster.

  • Leonid Gibiansky, Precision of Parameter Estimates: Covariance Step ($COV) versus Bootstrap Procedure, PAGE 16 (2007) Abstract 1106 [www.page-meeting.org/?abstract=1106] Abstract

  • Matthew M. Riggs, Marc R. Gastonguay, Leonid Gibiansky, Gary Zammit, Ken Sprenger, and Lynn Aneiro, Exposure-Response Modeling of the GABAA Receptor Partial Agonist NG2-73: An Approach for Determining Target Onset and Duration of Sleep Efficacy While Minimizing Next Morning Effects, 2007 Annual Meeting of American Psychiatric Association, (page 249) Abstract NR584.

  • Matthew M. Riggs, Leonid Gibiansky, Marc R. Gastonguay, Ken Sprenger, and Lynn Aneiro Exposure-Response Modeling of the GABAA Receptor Partial Agonist NG2-73, 2007 Annual Meeting, ACCP.

2006:
  • Ekaterina Gibiansky, Leonid Gibiansky, Model-Based Drug Development: Optimization of AQUAVAN® Injection Dosing for Minimal-to-Moderate Sedation, PAGE 15 (2006) Abstract 959 [www.page-meeting.org/?abstract=959] .

  • Leonid Gibiansky, Marc R. Gastonguay, R/NONMEM Toolbox for Simulation from Posterior Parameter (Uncertainty) Distributions, PAGE 15 (2006) Abstract 958 [www.page-meeting.org/?abstract=958]

  • J. Vornov, D. Braitman, E. Gibiansky, J. Jones. A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Parallel-Design, Drug Interaction Study of Fospropofol Disodium (FD) and Premedications in Healthy, Adult Subjects. Gastrointest Endosc. 63(5): AB195 (2006)

  • John T. Mondick, Leonid Gibiansky, Marc R. Gastonguay, Gareth J. Veal, Jeffrey S. Barrett, Acknowledging Parameter Uncertainty in the Simulation-Based Design of an Actinomycin-D Pharmacokinetic Study in Pediatric Patients with Wilms’ Tumor or Rhabdomyosarcoma, PAGE 15 (2006) Abstract 938 [www.page-meeting.org/?abstract=938]

  • Gastonguay MR, Gibiansky L. Acknowledging and Incorporating Uncertainty in Model-Based Inferences. ECPAG Conference (2006) Workshop Poster Session, Abstract.

  • Gastonguay MR, Gibiansky L. Acknowledging Parameter Uncertainty by Simulating from Posterior Distributions with NONMEM and R. MUFPADA Annual Meeting (2006) Abstract.

2005:
  • E. Gibiansky, M. Struys, L. Gibiansky, A. Vanluchene, J. Vornov, E. Mortier, E. Burak, L. Van Bortel. AQUAVAN® Injection, a Water-Soluble Prodrug of Propofol as a Bolus Injection: A Phase I Dose Escalation Comparison with DIPRIVAN®. Part I: Pharmacokinetics. Anesthesiology. 103(4):718-729, October 2005.

  • M. Struys, A. Vanluchene, E. Gibiansky, L. Gibiansky, J. Vornov, E. Mortier, L. Van Bortel. AQUAVAN® Injection, a Water-Soluble Prodrug of Propofol as a Bolus Injection: A Phase I Dose Escalation Comparison with DIPRIVAN®. Part II: Pharmacodynamics and safety. Anesthesiology. 103(4):730-743, October 2005.

  • Ekaterina Gibiansky, Leonid Gibiansky, Population Pharmacokinetic-Pharmacodynamic Model of GPI 15715 and GPI-Derived Propofol in Sedation and Comparison of Models for OAA/S Scores, Abstracts of American Society of Anesthesiologists, Annual Meeting, October 22-26, 2005, Atlanta, GA

  • R. Pruitt, L. Cohen, E. Gibiansky, C. Wang, S. Strayhorn, M Weinstein, et al. A randomized, open-label, multicenter, dose-ranging study of sedation with Aquavan injection (GPI 15714) during colonoscopy. Gastrointest Endosc.61:AB111 (2005).

  • E. Gibiansky, L. Gibiansky, and C. Wang, Model-based design of AQUAVAN® injection dose ranging Phase II study, Clinical Pharmacology & Therapeutics (2005) 79, P28–P28 Abstract

  • Ekaterina Gibiansky, Leonid Gibiansky, Pharmacokinetic/pharmacodynamic model of MOAA/S sedation score for GPI 15715 and GPI-derived propofol, American Society of Health-System Pharmacists Midyear Clinical Meeting and Exhibition, December 2005, Las Vegas, NE

  • E. Gibiansky, L. Gibiansky. Population PK/PD model of GPI 15715 and GPI-derived propofol in sedation and comparison of PK/PD models for ordered categorical observations, PAGE 14 (2005) Abstract 735 [www.page-meeting.org/?abstract=735]

  • Population Pharmacokinetic Model of Sedative Doses of GPI 15715 and Propofol Liberated from GPI 15715. Clinical Pharmacology & Therapeutics (2005) 77, p. 48 Abstract

2004:
  • W. Bachman, L. Gibiansky Automated Evaluation of Population Pharmacokinetic and Pharmacodynamic Models, American Association of Pharmaceutical Scientists, Annual Meeting, 2004. Abstract

  • E. Gibiansky; M.Struys; L. Gibiansky. Pharmacokinetics and Pharmacodynamics of AQUAVAN® bolus injection: a population PK/PD model. Eur. J. Anaesthesiology, Vol. 21, Sup. 32, 2004, p.15

  • Gibiansky L. NONMEM Non-Influential Correlated ETAs Bug and How to Fix It. AAPS Annual Meeting: PPDM Poster-Podium Session, 2004. Abstract

  • Farah BM, Ogola S, Anzala O, Indangasi J, Tarragona A, Gibiansky L, Bwayo J., Development and validation of gamma interferon ELISPOT assay for HIV-1 vaccine trials in Kenya. Int Conf AIDS. 2004 Jul 11-16; 15: Abstract A10070.

2003:
  • M. Gastonguay, E. Gibiansky, L. Gibiansky, and J. Barrett, Optimizing a Bayesian Dose-Adjustment Scheme for a Pediatric Trial: A Simulation Study, in Simulation for Designing Clinical Trials, A Pharmacokinetic-Pharmacodynamic Modeling Perspective (Drugs and The Pharmaceutical Sciences Series, Volume 127), Edited by H. Kimko, S. Duffull, Marcel Dekker, Inc, NY, NY 2003.

  • L. Gibiansky, M. Struys, E. Gibiansky, Simultaneous Population Pharmacokinetic Model of Aquavan and Aquavan – Derived Propofol, PAGE 12 (2003) Abstract 412 [www.page-meeting.org/?abstract=412]

  • E. Gibiansky, M. Struys, L. Gibiansky, Bispectral Index of Aquavan-Derived Propofol: Population PK/PD Modeling and Application to an Effect – Controlled Trial, PAGE 12 (2003) Abstract 413 [www.page-meeting.org/?abstract=413]

  • Earlier Publications in Pharmacometrics

  • Earlier Publications in Applied Mathematics


    • Patents:

    • E. Gibiansky, L. Gibiansky, Methods of dosing Propofol prodrugs for inducing mild to moderate levels of sedation, U.S. Application Serial No. 60/698, 404, filed on July 12, 2005 Abstract

    • P. Wingard, E. Burak, E. Gibiansky, J. Vornov. Pharmaceutical compositions containing water-soluble prodrugs of propofol and methods of administering same. U.S. Patent Application Serial No. 10509627, 2005 Abstract

    • W. Gillespie, L. Gibiansky, D. Young, S. Bigora, C. Farrell, T. Shepard, Tools for In Vitro In Vivo Correlation, submitted in 2002, Pub. Number EP1552463 (2005), US Patent 7027970 Issued on April 11, 2006. Abstract

    • L. Gibiansky, Yu. Galperin, and V. Fishman, Method for optimizing net present value of a cross-selling marketing campaign, US Patent 6993493 Issued on January 31, 2006. Abstract