2010:
  • 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, in preparation, 2010
  • Ekaterina Gibiansky, Jianping Zhang, Daphne Williams, Zhao Wang, Daniele Ouellet, Population Pharmacokinetics of Eltrombopag in Healthy Subjects and Patients with Chronic Idiopathic Thrombocytopenic Purpura, to appear in Journal of Clinical Pharmacology, 2010
  • Leonid Gibiansky, Ekaterina Gibiansky, Bipin Mistry, Population Pharmacokinetic and Pharmacodynamic Modeling of Fospropofol Injection in Patients, submitted to ASA Annual Meeting, San Diego, 2010
  • 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.
  • Leonid Gibiansky, Ekaterina Gibiansky, Target-Mediated Drug Disposition Model for Drugs That Bind to More than One Target, submitted to Journal of Pharmacokinetics and Pharmacodynamics.
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).
  • 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]
  • 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, P48–P48 a href="pdf_files/ascpt_2005_ppkmodelgpi.pdf" target="_blank"> 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