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Tornoe CW, Garnett CE, Wang Y, Florian J, Li M, Gobburu JV. Creation of a Knowledge Management System for QT Analysis. J Clin Pharmacol published online 26 October 2010. DOI: 10.1177/0091270010378408.

Russell J. Pharsight and Tripos Evolve, Prep PKS Online Launch. Bio-IT World [serial online]. August 10, 2009.

Corrigan BW et al. Model-Based Meta-Analyses vs. Clinical Impressionism: Challenges and Rewards. AAPS Newsmagazine, September 2007, pages 26-27. Available at www.aapspharmaceutica.com.

Weiner D, Marier JF, Hovde M. Do You Compute? Drug Discovery & Development [serial online]. September, 2007.

Weiner D. Modeling, Simulation, and the Critical Path. Drug Discovery & Development [serial online]. December, 2006.

Creating a Data Platform for Modeling and Simulation. Interview with Daniel Weiner, Ph.D., Senior Vice President, Software Products, Pharsight Corporation. Beikoku Seiyaku Gyokai Shuho (U.S. Pharmaceutical Industry Weekly Report). [serial newsletter]. July 14, 2006. Used with permission from publisher, MSA Partners LLC, New York.

Russell J. Pharsight Lands CRADA to Assist FDA with Modeling Initiative. Bio-IT World [serial online]. June 9, 2006.

Powell B, Gobburu J, Lee P. U.S. View on the Role of PK/PD in Drug Approval-Discussion on the Basis of Examples. FDA, Silver Spring, MD. Abstract of presentation delivered at The 5th International Symposium on Measurement and Kinetics of In-Vivo Drug Effects. April 2006. Leiden, Netherlands.

Clinical Modeling Hits Prime Time. Drug Discovery & Development [serial online]. March, 2006.

Kamath L. Modeling Success in PK/PD Testing. Drug Discovery & Development [serial online]. February, 2006.

PK/PD Simulation Speeds Decision Making. Bio-IT World Best Practices [serial online]. January 23, 2006.

J. Robert Powell, Edward J. Randinitis, Jack A. Cook, Richard L. Lalonde. Releasing the Human Spirit in Developing Drugs: Increasing Clinical Pharmacokinetics Productivity. International Journal of Pharmaceutical Medicine, Volume 18, Number 1, 2004, pp. 13-17(5).

Mandema JW, Hermann D, Wang W, Sheiner T, Milad M, Bakker-Arkema R, Hartman D. Model-Based Development of Gemcabene, a New Lipid-Altering Agent. AAPS Journal. 2005; 7(3). Available at AAPS website, http://aapsj.org

Russell J. Pfizer's Model of Success. Bio-IT World [serial online]. August 15, 2005. Available at http://www.bio-itworld.com/issues/2005/August-2005/bp-pfizer.

Pharsight Software Used for FDA's Critical Path Initiative [news release]. Bio-IT World. February 25, 2005. Reprinted with permission from BioWorld® today, Atlanta, Georgia.

Uehling MD. Model Patient. Bio-IT World [serial online]. December 15, 2003. Available at http://www.bio-itworld.com/archive/121503/trials.html.

Pharsight Corporation. Bibliography for Computer Assisted Trial Design (CATD).

Gabrielsson J, Weiner D. Pharmacokinetic and Pharmacodynamic Data Analysis, Concepts and Applications, 3rd ed. Stockholm, Sweden: Swedish Pharmaceutical Press; 2001. ISBN 91-8627-492-9.

Models That Take Drugs [report]. The Economist. June 9, 2005. Copyright 2005 Reprinted with permission from the Economist Newspaper Group Limited.

 

Consulting Services


2012

 

Leeds J, Fenneteau F, Gosselin N, Mouksassi M, Kassir N, Marier J, Chen Y, Grosenbach D, Frimm A, Honeychurch K, Chinsangaram J, Tyavanagimatt S, Hruby D, Jordan R. Pharmacokinetic and Pharmacodynamic Modeling to Determine the Human Dose of ST-246(R) to Protect Against Smallpox. Antimicrobial Agents and Chemotherapeutics. Volume 57. Issue 3, pp. 1136-43. March 2013

 

Rohatagi S, Mendell J, Kastrissios H, Green M, Shi M, Patel I, Salazar D. Characterization of exposure versus response of edoxaban in patients undergoing total hip replacement surgery. Thrombosis and Haemostasis. Volume 108. Issue 5, pp. 887-95. November 2012

 

Bruno R, Lindbom L, Schaedeli Stark F, Chanu P, Gilberg F, Frey N, Claret L. Simulations to Assess Phase II Non-Inferiority Trials of Different Doses of Capecitabine Plus Docetaxel for Metastatic Breast Cancer. Pharmacometrics and System Pharmacology. 26 December 2012.

 

Mandel M, Mercier F, Eckert B, Chin P, Betensky R. Estimating time to disease progression comparing transition models and survival methods - an analysis of multiple sclerosis data. Biometrics. Epub. 14 February 2012.

 

El Majidi N, Bouchard, M, Gosselin NH, Carrier G. Relationship between prenatal exposure to polychlorinated biphenyls and birth weight: a systematic analysis of published epidemiological studies through a standardization of biomonitoring data. Regulatory Toxicology and Pharmacology. Volume 64, Issue 1, pp. 161-76. October 2012.

 

Mercier F, Chin P, Francis G. Dealing with excess of zeroes in the statistical analysis of MRI lesion count in multiple sclerosis. Pharmaceutical Statistics. Volume 11, Issue 5, pp. 417-424. 6 Aug 2012.

 

Claret L, Lue JF, Bruno R, Hsu CP, Hei YJ, Sun YN. Simulations Using a Drug-Disease Modeling Framework and Phase II Data Predict Phase III Survival Outcome in First-Line Non-Small-Cell Lung Cancer. Clinical pharmacology & Therapeutics (2012). 22 August 2012.

 

Miller B, Hershberger E, Benziger D, Trinh MM, Friedland I. Pharmacokinetics and Safety of Intravenous Ceftolozane/tazobactam in Healthy Adult Subjects following Single and Multiple Ascending Doses. Antimicrob Agents Chemother. 2012 Mar 26.

 

Salazar DE, Mendell J, Kastrissios H, Green M, Carrothers TJ, Song S, Patel I, Bocanegra TS, Antman EM, Giugliano RP, Kunitada S, Dornseif B, Shi M, Tachibana M, Zhou S, Rohatagi S. Modelling and simulation of edoxaban exposure and response relationships in patients with atrial fibrillation. Thromb Haemost. 2012 Mar 8;107(5).

 

2011 (Selected Publications)

Zuppa A, Hammer GB, Barrett JS, Kenney BF, Kassir N, Moukassi S, Royal M. Safety and Population Pharmacokinetic Analysis of Intravenous Acetaminophen in Neonates, Infants, Children and Adolescents with Pain or Fever. Journal of Pediatric Pharmacology and Therapeutics. Volume 16, Issue 4, pp. 246-61. October 2011.

 

Salazar DE, Song SH, Shi J, Rohatagi S, Heyrman R, Wada DR, Carrothers TJ. The Use of Modeling and Simulation to Guide Clinical Development of Olmesartan Medoxomil in Pediatric Subjects. Clinical Pharmacology & Therapeutics, 28 December 2011.

Darwish M, Bond M, Ezzet F. Armodafinil and Modafinil in Patients With Excessive Sleepiness Associated With Shift Work Disorder: A Pharmacokinetic and Pharmacodynamic Model for Predicting and Comparing Their Concentration-Effect Relationships. J Clin Pharmacol, October 30, 2011.

Mao ZL, Townsend RW, Gao C, Wheeler JJ, Kastrissios H, Keirns J. Population Pharmacokinetics of Vernakalant Hydrochloride Injection (RSD1235) in Patients With Atrial Fibrillation or Atrial Flutter. J Clin Pharmacol 9 June 2011.

Marier JF, Pheng L, Trinh MM, Burris HA 3rd, Jones S, Anderson K, Warner S, Porubek D. Pharmacokinetics of SN2310, an injectable emulsion that incorporates a new derivative of SN-38 in patients with advanced solid tumors. J Pharm Sci.
2011 May 31.

Soria JC, Cortes J, Massard C, Armand JP, De Andreis D, Ropert S, Lopez E, Catteau A, James J, Marier JF, Beliveau M, Martell RE, Baselga J. Phase I safety, pharmacokinetic and pharmacodynamic trial of BMS-599626 (AC480), an oral pan-HER receptor tyrosine kinase inhibitor, in patients with advanced solid tumors.
Ann Oncol. 2011 May 16.

Lichter-Konecki U, Diaz GA, Merritt JL, Feigenbaum A, Jomphe C, Marier JF, Beliveau M, Mauney J, Dickinson K, Martinez A, Mokhtarani M, Scharschmidt B, Rhead W.   Ammonia control in children with urea cycle disorders (UCDs); Phase 2 comparison of sodium phenylbutyrate and glycerol phenylbutyrate. Mol Genet Metab. 2011 May 5.

Marier JF, Trinh MM, Pheng LH, Palleja SM, Martin DE. Pharmacokinetics and Pharmacodynamics of TBR-1 652, a Novel CCR5 Antagonist, in HIV-1-Infected, Antiretroviral Treatment-Experienced and CCR5 Antagonist-Naïve Patients. Antimicrobial Agents and Chemotherapy. 2011 Jun;55(6):2768-74.

Kastrissios H , Walker JR, Carrothers TJ , Kshirsagar S, Khariton T, Habtemariam B, Mager DE, Rohatagi S. Population Pharmacokinetic Model for a Novel Oral Hypoglycemic Formed In Vivo: Comparing the Use of Active Metabolite Data Alone Versus Using Data of Upstream and Downstream Metabolites. J Clin Pharmacol, 21 March 2011.

Krishna R, Bergman AJ, Green M, Dockendorf MF, Wagner JA, Dykstra K. Model-Based Development of Anacetrapib, a Novel Cholesteryl Ester Transfer Protein Inhibitor. The AAPS Journal. DOI: 10.1208/s12248-011-9254-0.


2010 (Selected Publications)

Bax L, Moons KG. Beyond Publication Bias. J Clin Epidemiol. 2011 May;64(5):459-62. Epub 2010 Dec 30.

Weitz JI, Connolly SJ, Patel I, Salazar D, Rohatagi S, Mendell J, Kastrissios H, Jin J, Kunitada S. Randomised, parallel-group, multicentre, multinational phase 2 study
comparing edoxaban, an oral factor Xa inhibitor, with warfarin for
stroke prevention in patients with atrial fibrillation.
Thrombosis and Haemostasis 2010; 104: 633?641.

Claret L, Lu JF, Sun YN, Bruno R. Development of a Modeling Framework to Simulate Efficacy Endpoints for Motesanib in Thyroid Cancer Patients. Cancer Chemotherapy and Pharmacology, Volume 66, Number 6, 1141-1149, DOI: 10.1007/s00280-010 1449-z.

Lu JF, Claret L, Sutjandra L, Kuchimanchi M, Melara R, Bruno R, Sun YN. Population Pharmacokinetic/Pharmacodynamic Modeling for the Time Course of Tumor Shrinkage by Motesanib in Thyroid Cancer Patients. Cancer Chemotherapy and Pharmacology, Volume 66, Number 6, 1151-1158, DOI: 10.1007/s00280-010-1456-0.

Bruno R, Lu JF, Sun YN, Claret L. A Modeling and Simulation Framework to Support Early Clinical Drug Development Decisions in Oncology. J Clin Pharmacol. July 13, 2010

Claret L, Lu J, Bruno R, Sikorski S, Hei Y, Sun Y. Simulation of phase III studies of motesanib 125 mg once daily (QD) plus carboplatin/paclitaxel (CPM) or bevacizumab plus carboplatin/paclitaxel (CPB) versus carboplatin/paclitaxel (CP) in first-line non-small cell lung cancer (NSCLC) using a public domain drug-disease modeling framework and phase II data. J Clin Oncol 28, 2010.

Karlsson KE, Wilkins JJ, Jonsson F, Zingmark PH, Karlsson MO, Jonsson EN. Modeling disease progression in acute stroke using clinical assessment scales. AAPS J. (2010) 12(4):683-91. 2010 Sep 21.

Fleury A, Lavé T, Jonsson F, Schmitt M, Hirkaler G, Polonchuk L, Breidenbach A.
A pharmacokinetic-pharmacodynamic model for cardiovascular safety assessment of R1551. J Pharmacol Toxicol Methods. 2011 Jan-Feb;63(1):123-33. 2010 Aug 21.

McGuire BM, Zupanets IA, Lowe ME, Xiao X, Syplyviy VA, Monteleone J, Gargosky S, Dickinson K, Martinez A, Mokhtarani M, Scharschmidt BF. Pharmacology and safety of glycerol phenylbutyrate in healthy adults and adults with cirrhosis. Hepatology. 2010 Jun;51(6):2077-85.

Wilfley D, Van Buren DJ, Theim KR, Stein RI, Saelens BE, Ezzet F, Russian AC, Perri MG, Epstein LH. The Use of Biosimulation in the Design of a Novel Multilevel Weight Loss Maintenance Program for Overweight Children. Obesity, Volume 18, Supplement 1, pp. S91-S98; February 2010.

Chanu P, Gieschke R, Charoin JE, Pannier A, Reigner B. Population Pharmaco-kinetic/Pharmacodynamic Model for a C.E.R.A. in Both ESA-Naïve and ESA-Treated Chronic Kidney Disease Patients With Renal Anemia. The Journal of Clinical Pharmacology published 23 February 2010.

2009 (Selected Publications)

Houk BE, Bello CL, Poland B, Rosen LS, Demetri GD, Motzer, RJ. Relationship between exposure to sunitinib and efficacy and tolerability endpoints in patients with cancer: results of a pharmacokinetic/pharmacodynamic meta-analysis. Cancer Chemother Pharmacol published online 5 December, 2009. DOI 10.1007/s00280-009-1170-y.

Rohatagi S, Carrothers TJ, Wagg JK, Khariton T. Is a Thorough QTc Study Necessary? The Role of Modeling and Simulation in Evaluating the QTc Prolongation Potential of Drugs.  J Clin Pharmacol published Sep 4, 2009 as doi:10.1177/0091270009341184.

Claret L, Girard P, Hoff PM, Van Cutsem E, Zuideveld KP, Jorga K, Fagerberg J, Bruno R. Model-Based Prediction of Phase III Overall Survival in Colorectal Cancer on the Basis of Phase II Tumor Dynamics. Journal of Clinical Oncology published online ahead of print Jul 27 2009; 10.1200/JCO.2008.21.0807.

Bruno R, Claret L. On the Use of Change in Tumor Size to Predict Survival in Clinical Oncology Studies: Toward a New Paradigm to Design and Evaluate Phase II Studies. Clin Pharmacol Ther 86: 136-138; doi:10.1038/clpt.2009.97.

Poland B, Hodge FL, Khan A, Clemen RT, Wagner JA, Dykstra K, Krishna R. The Clinical Utility Index as a Practical Multiattribute Approach to Drug Development Decisions. Clin Pharmacol Ther. May 20, 2009; doi:10.1038/clpt.2009.71.

2008 (Selected Publications)

Rohatagi S, Zahir H, Moberly JB, Truitt KE, Inaba S, Shimozato T, Carrothers TJ.
Use of an Exposure-Response Model to Aid Early Drug Development of an Oral Sphingosine 1-Phosphate Receptor Modulator.
J Clin Pharmacol. 23 October 2008, 10.1177/0091270008325672.

Rohatagi S, Carrothers TJ, Jin JY, Jusko WJ, Khariton T, Walker J, Truitt K, Salazar DE. Model-Based Development of a PPAR-gamma Agonist, Rivoglitazone, to Aid Dose Selection and Optimize Clinical Trial Designs. J Clin Pharmacol. 21 October 2008, 10.1177/0091270008323260.

Rohatagi S, Kastrissios H, Sakahara K, Truitt K, Moberly JB, Wada R, Salazar DE. Pain relief model for a COX-2 inhibitor in patients with postoperative dental pain. Br J Clin Pharmacol. 2008 Jul;66(1):60-70.

Krishna R, Bergman AJ, Jin B, Fallon M, Cote J, Van Hoydonck P, Laethem T, Gendrano IN, Van Dyck K, Hilliard D, Laterza O, Snyder K, Chavez-Eng C, Lutz R, Chen J, Bloomfield DM, De Smet M, Van Bortel LM, Gutierrez M, Al-Huniti N, Dykstra K, Gottesdiener KM, Wagner JA. Multiple-Dose Pharmacodynamics and Pharmacokinetics of Anacetrapib, a Potent Cholesteryl Ester Transfer Protein (CETP) Inhibitor, in Healthy Subjects. Clinical Pharmacology & Therapeutics 84, 679 - 683 (25 Jun 2008).

Rohatagi S, Carrothers TJ, Kshirsagar S, Khariton T, Lee J, Salazar D. Evaluation of Population Pharmacokinetics and Exposure-Response Relationship With Coadministration of Amlodipine Besylate and Olmesartan Medoxomil. J Clin Pharmacol published 19 May 2008, 10.1177/0091270008317847.

2007 and Earlier Publications (Selected)


Rohatagi S, Kastrissios H, Gao Y, Zhang N, Xu J, Moberly J, Wada R, Yoshihara K, Truitt K, Salazar D. Predictive population pharmacokinetic/pharmacodynamic model for a novel COX-2 inhibitor. J Clin Pharmacol. 2007 Mar;47(3):358-70.

Kastrissios H, Rohatagi S, Moberly J, Truitt K, Gao Y, Wada R, Takahashi M,
Kawabata K, Salazar D. Development of a predictive pharmacokinetic model for a novel cyclooxygenase-2 inhibitor. J Clin Pharmacol. 2006 May;46(5):537-48.

Claret L, Cox H, McFadyen L, Pidgen A, Johnson J, Haughie S, Boolell M, Bruno R.
Modeling and Simulation of Sexual Activity Daily Diary Data of Patients with Female Sexual Arousal Disorder Treated with Sildenafil Citrate (Viagra®). Pharmaceutical Research. 2006; Vol. 23, No. 8, pages 1756-1764.

Lowe D. What You Need to Know About Adaptive Trials. Pharmaceutical Executive [serial online]. July 1, 2006. Available at http://pharmexec.com.

Kazutaka Y, Gao Y, Shiga H, Wada DR, Hisaoka M. Population Pharmacokinetics of Olmesartan Following Oral Administration of its Prodrug, Olmesartan Medoxomil: In Healthy Volunteers and Hypertensive Patients. Clinical Pharmacokinetics. 2005; Volume 44, Number 12; pp. 1329-1342(14).

Mandema JW, Hermann D, Wang W, Sheiner T, Milad M, Bakker-Arkema R, Hartman D. Model-Based Development of Gemcabene, a New Lipid-Altering Agent. AAPS Journal. 2005; 7(3). Available at AAPS website, http://aapsj.org

Korsan B, Dykstra K, Pullman W. Transparent Trade-Offs: A Clinical Utility Index (CUI) Openly Evaluates a Product's Attributes — and Chance of Success Pharmaceutical Executive. March 2005.

Russell J. FDA Mulls Drug/Disease Model Library. Bio-IT World [serial online]. December 19, 2005. Available at http://www.bio-itworld.com/newsitems/2005/dec2005/12-19-05-news-fda-models

Krause A, Millard S (Editors). Applied Statistics in the Pharmaceutical Industry with Case Studies Using S-Plus. Springer-Verlag, New York; 2001. ISBN 0-387-988149.

Janssen P, Prins NH, Peeters PJ, Zuideveld KP, Lefebvre R. 5-HT7 receptor efficacy distribution throughout the canine stomach. British Journal of Pharmacology. 2004;143:331?342. Abstract and full text available online at: http://www.nature.com/bjp.

Pillai G, Gieschke R, Goggin T, Jacqmin P, Schimmer RC, Steimer JL.
A semimechanistic and mechanistic population PK-PD model for biomarker response to ibandronate, a new biophosphonate for the treatment of osteoporosis.
British Jounrnal of Clinical Pharmacology. 2004, 58:6, 618-631. Available from Blackwell Publishing, Ltd.

Poland B, Wada R. Combining drug-disease and economic modelling to inform drug development decisions Drug Discovery Today. November 2001;6(22):1165-1170.

Sheiner LB, Learning vs Confirming in Clinical Drug Development, Clin. Pharmacol. Ther., 1997, 61:275-291

Savant I, Mouksassi MS, Kassir N, Marier JF, Zhu W, Lau H. Population Pharmacokinetics of Apremilast (CC-1004) in Subjects with Active Psoriatic Arthritis. Journal of Clinical Pharmacology, 2010, 50(9), #135, pp. 1088.

Mouksassi MS, Marier JF, Cyran J, Vinks AA. Clinical Trial Simulations in Pediatric Patients Using Realistic Covariates: Application to Teduglutide, a Glucagon-Like Peptide-2 Analog in Neonates and Infants With Short-Bowel Syndrome. Clinical Pharmacology & Therapeutics (2009); advance online publication 21 October 2009. doi:10.1038/clpt.2009.199.

Marier JF, Mouksassi MS, Gosselin NH, Beliveau M, Cyran J, Wallens J. Population Pharmacokinetics of Teduglutide Following Repeated Subcutanenous Administrations in Healthy Participants and in Patients With Short Bowel Syndrome and Crohn's Disease. J. Clin. Pharmacol; 2009 Sep 22. [Epub ahead of print].

Babbar S, Marier JF, Mouksassi MS, Beliveau M, Vanhove GF, Chanda S, Bley K. Pharmacokinetic Analysis of Capsaicin After Topical Administration of a High-Concentration Capsaicin Patch to Patients With Peripheral Neuropathic Pain.
Ther Drug Monit. 2009; 10.1097/FTD.0b013e3181a8b200.

Rakha EA, Elsheikh SE, Aleskandarany MA, Habashi HO, Green AR, Powe DG, El-Sayed ME, Benhasouna A, Bruet JS, Akslen LA, Evans AJ, Blamey R, Reis-Filho JS, Foulkes WD, Ellis IO. Triple-Negative Breast Cancer: Distinguishing between Basal and Nonbasal Subtypes. Clin Cancer Res 2009;15(7) April 1, 2009.

Pettersen G, Mouksassi MS, Theoret Y, Labbe L, Faure C, Nguyen B, Litalien C. Population Pharmacokinetics of Intravenous Pantoprazole in Paediatric Intensive Care Patients. Br J Clin Pharmacol; 2008; DOI:10.1111/j.1365-2125.2008.03328.x.

Marier JF, Beliveau M, Mouksassi MS, Shaw P, Cyran J, Kesavan J, Wallens J, Zahir H, Wells D, Caminis J. Pharmacokinetics, Safety, and Tolerability of Teduglutide, a Glucagon-Like Peptide-2 (GLP-2) Analog, Following Multiple Ascending Subcutaneous Administrations in Healthy Subjects. J. Clin. Pharmacol. 2008; 48; 1289; DOI: 10.1177/0091270008320605.