Methodology, Tools, and Computation

R as the core technology to support modeling and simulation in pharma research, development, and post approval activities

Gastonguay MR. Lightning Talk presented at the 1st annual R/Pharma conference. Boston, MA. 16 August 2018.

Assisting pharmacometric simulation with the use of Shiny

Kang J. Lightning Talk presented at the 1st annual R/Pharma conference. Boston, MA. 16 August 2018.

Moving fast without breaking things: navigating the R ecosystem in an enterprise environment

Pastoor D. Invited Talk presented at the 1st annual R/Pharma conference. Boston, MA. 15 August 2018.

Torsten: Stan functions for pharmacometrics applications

Gillespie WR. Presented at Stan for Pharmacometrics. Paris, France. 24 July 2018.

The pharmacokinetics and pharmacodynamics of buprenorphine in neonatal abstinence syndrome

Moore JN, Gastonguay MR, Ng CM, Adeniyi-Jones SC, Moody DE, Fang WB, Ehrlich ME, Kraft WK. Clin Pharmacol Ther. 103 (6) 1029-1037; June 2018

Polymorphisms in cytochrome P450 are associated with extensive efavirenz pharmacokinetics and CNS toxicities in an HIV cohort in Botswana

Vujkovic M, Bellamy SL, Zuppa AF, Gastonguay MR, Moorthy GS, Ratshaa B, Han X, Steenhoff AP, Mosepele M, Strom BL, Bisson GP, Aplenc R, Gross R. Pharmacogenomics J. doi: 10.1038/s41397-018-0028-2. Epub June 1, 2018.

A joint design for functional data with application to scheduling ultrasound scans

Park SY, Xiao L, Wilbur JD, Staicu A, Jumbe NL. Computational Statistics and Data Analysis. 122:101-114. June 2018

Bayesian data analysis using Stan/Torsten for pharmacometric applications

Gillespie WR. Presented at the Midwest Biopharmaceutical Statistics Workshop (MBSW), Indianapolis, IN, May 2018.

A perspective on the state of pharmacometrics and systems pharmacology integration

Trame MN, Riggs M, Biliouris K, Marathe D, Mettetal J, Post TM, Rizk ML, Visser SAG, Musante CJ.  CPT Pharmacometrics Syst Pharmacol. doi: 10.1002/psp4.12313. 2018 May 15.

Modeling methods for analyzing tumor dynamic data from basket trials

Ocampo-Pelland AS, French JL.  Presented at the 8th American Conference on Pharmacometrics (ACoP), Fort Lauderdale, FL, October 2017.

Post-approval decision making supported by modeling and simulation based on a variety of data sources

Gastonguay MR. Presented at the 8th American Conference on Pharmacometrics (ACoP), Fort Lauderdale, FL, October 2017.

Gaining efficiency by combining analytical and numerical methods to solve ODEs: Implementation in Stan and application to Bayesian PK/PD modeling

Margossian C and Gillespie WR.  Presented at the 8th American Conference on Pharmacometrics (ACoP), Fort Lauderdale, FL, October 2017.

Points to consider when making inferences about covariates

Gastonguay MR. Presented at the 8th American Conference on Pharmacometrics (ACoP), Fort Lauderdale, FL, October 2017.

Theory, empiricism, and a vision for the continued growth of pharmacometrics

Gastonguay MR.  The International Society of Pharmacometrics Lewis B. Sheiner Award Lecture presented at the 8th American Conference on Pharmacometrics (ACoP), Fort Lauderdale, FL, October 15, 2017.

A joint optimal design for functional data with application to scheduling ultrasound scans

Park SY, Xia L, Wilbur J, Staicu AM, Jumbe NL.  Paper presented at: Eastern North American Region (ENAR) Spring Meeting of the International Biometric Society, March 2017, Washington, DC.

Evaluating effectiveness of case-matching for exposure-response analysis

Wilbur JD, Gupta M, Passey C, Roy A.  Poster presented at Eastern North American Region (ENAR) Spring Meeting of the International Biometric Society, March 2017, Washington, DC; Abstract 57d.

Stan functions for Bayesian pharmacometric modeling

Margossian CC and Gillespie WR.  Presented at the 7th American Conference on Pharmacometrics (ACoP), Bellevue, WA; October 2016.

MBMA of combined individual and aggregate data: strategies and issues

Gillespie WR. Presented at the 7th American Conference on Pharmacometrics (ACoP), Bellevue, WA; October 2016.

Bayesian pharmacometric modeling with BUGS, NONMEM, and Stan

Gillespie WR.  Presented at the 7th American Conference on Pharmacometrics (ACoP), Bellevue, WA; October 2016.

Causal models with pharmacometric applications

French JL.  Presented at the 7th American Conference on Pharmacometrics (ACoP), Bellevue, WA; October 2016.

Interactive simulation-based assessment of “go/no-go” decision making in Duchenne muscular dystrophy clinical trials

Hajjar J, French JL, Gastonguay MR.  Presented at the 7th American Conference on Pharmacometrics (ACoP), Bellevue, WA; October 2016.

Automation of Population Pharmacokinetic-Pharmacodynamic Modeling Reports Using the RShiny Application: TFL Generator

Melhem M, Polhamus D, Lau T, Chen P, Narayanan A, Clements JD, Gibbs J, Seegan G.  Presented at the 7th American Conference on Pharmacometrics (ACoP), Bellevue, WA; October 2016.

Prototype Stan functions for Bayesian pharmacometric modeling

Gillespie WR and Margossian CC.  Presented at Stan for Pharmacometrics Day, Paris 22 Sep 2016.

Facilitating clinical trial simulation in Alzheimer’s disease using the CAMD IPD, literature summary level data, and the ‘adsim’ R package

Polhamus D.  Presented at The Joint Statistical Meetings (JSM), August, 2016.

Optimal design for sampling functional data

Park SY, Xia L, Wilbur J, and Staicu, AM.  Presented at The Joint Statistical Meetings (JSM), August 2016, Chicago, IL; Abstract 319197.

Comparisons of multiple exposure-response methodologies in oncology.

Polhamus D, French J, Chen SC, Wang B, Li C, Lu D, Girish S, Jin J, Quartino A.  Presented at the Annual Meeting of the Population Approach Group in Europe (PAGE), Lisboa, June 2016.

Comparison of recursive partitioning analysis and receiver operating characteristic (ROC) analysis for patient identification

Chen SC, Riggs MM, Nueesch E, Strasak A, French J, Jin J, Girish S, Li C.  Presented at the Annual Meeting of the Population Approach Group in Europe (PAGE), Lisboa, June 2016.

A case study in comparing cognitive development across populations

French JL, Racine A, van Buuren S, Haggstrom J.  Presented at the Annual Meeting for the Population Approach Group in Europe (PAGE), Lisboa, June 2016.

Evaluating effectiveness of case-matching for exposure-response analysis

Wilbur JD, Gupta M, Passey C, Roy A.  Presented at the Annual Meeting of the Population Approach Group in Europe (PAGE), Lisboa, June 2016.

Zika microcephaly cutoffs revisited: A study of Non-parametric methods in fetal growth

Wilbur JD, Ohuma E, Xiao L, Mouksassi S, Hafen R.  Presented at the Annual Meeting of the Population Approach Group in Europe (PAGE), Lisboa, June 2016.

The role of simulation in assessing extrapolation assumptions

Gastonguay MR.  Presented at the Quantitative Assessment of Assumptions to Support Extrapolation of Efficacy in Pediatrics: FDA – U Maryland CERSI Cosponsored Workshop.  FDA. June 1, 2016.

Comparing the performance of four open-source methods for multiple parameter estimation in a systems pharmacology model

Eudy RJ, Riggs MM, Baron K.  Presented at the Sanofi–MSISB Mount Sinai Systems Pharmacology Symposium, June 2016.

Estimation of exposure-response relationships in the presence of confounding

French JL.  Presented at Trends and Innovation in Clinical Trial Statistics Conference, Durham, NC; May 2016.

Big Data: Challenges and opportunities for clinical pharmacology

Flockhart D, Bies RR, Gastonguay MR, Schwartz SL.  Br J Clin Pharmacol. 2016 May;81(5):804-6.

Model-based meta-analysis for development of a population-pharmacokinetic (PPK) model for Vitamin D3 and its 25OHD3 metabolite using both individual and arm-level data

Ocampo-Pelland AS, Gastonguay MR, French JF, Riggs MM.  J Pharmacokinet Pharmacodyn. 2016 Apr;43(2):191-206.

Facilitating cardiovascular safety exposure-response modeling in early-phase clinical studies with the cardioModel package for R

Conrado DJ, Hather GJ, Chen D, Denney WS. Facilitating Cardiovascular Safety Exposure-Response Modeling in Early-Phase Clinical Studies with the cardioModel Package for R.  Presented at the 6th American Conference on Pharmacometrics (ACoP), Arlington, VA, October 2015

A pharmacometrician’s perspective for utilization of big data

Gastonguay MR.  Presented at the 6th American Conference on Pharmacometrics (ACoP), Arlington, VA; October 2015.

A modeling and simulation framework for exposure-response analysis in oncology: comparison and considerations of multiple methodologies

Polhamus D, French J, Chen S-C, Wang B, Li C, Lu D, Girish S, Jin J, Quartino A.  Presented at the 6th American Conference on Pharmacometrics, Arlington, VA; October 2015.

Simulation from ODE-based population PK/PD and systems pharmacology models in R with mrgsolve

Baron KT and Gastonguay MR.  Presented at the 6th American Conference on Pharmacometrics (ACoP), Arlington, VA; October 2015.

Linking a mechanistic model of bone mineral density to a time-to-event model of fracture

Eudy RF, Gillespie WR, Riggs MM, Gastonguay MR.  Presented at the 6th American Conference on Pharmacometrics (ACoP), Arlington, VA; October 2015.

Trends in the application of pharmacometric modeling and simulation in the development of orphan drugs in the 21st century

Hajjar J, Fisher J, Gastonguay MR.  Presented at the 6th American Conference on Pharmacometrics (ACoP), Arlington, VA; October 2015.

Implementing FDA specifications in R for submission of analysis datasets

Bergsma T and Pivirotto S.  Presented at the 6th American Conference on Pharmacometrics (ACoP), Arlington, VA, October 2015.

Modeling & simulation: Filling the knowledge gap in rare diseases. Return on Investment on the Utilization of Systems Pharmacology and pharmacometrics in drug development for rare diseases: challenges and opportunities

Gastonguay MR and Godfrey CJ.  American College of Clinical Pharmacology (ACCP) Workshop, September 26, 2015.

A priori identifiability of target-mediated drug disposition models and approximations

Eudy RJ, Riggs MM, Gastonguay MR. AAPS J. 2015 Sep;17(5):1280-4.

Assessment of propensity score and Mahalanobis distance matching in the exposure-response setting

Polhamus D, French J.  Presented at the Annual Meeting of the Population Approach Group in Europe (PAGE), Hersonissos, Greece; June 2015.

Model-based meta-analysis for development of a population pharmacokinetic (PPK) model for vitamin D3 and its 25OHD3 metabolite

Ocampo-Pellend AS, Gastonguay, French JL, Riggs MM. Presented at the Annual Meeting of the Population Approach Group in Europe (PAGE), Hersonissos, Greece; June 2015.

FDA advisory meeting clinical pharmacology review utilizes a quantitative systems pharmacology (QSP) model: A watershed moment?

Peterson MC and Riggs MM.  CPT: Pharmacometrics & Systems Pharmacology, 2015 Mar; 4(3).

Modeling and simulation for medical product development and evaluation: highlights from the FDA-C-Path-ISOP 2013 workshop

Romero K, Sinha V, Allerheiligen S, Danhof M, Pinheiro J, Kruhlak N, Wang Y, Wang SJ, Sauer JM, Marier JF, Corrigan B, Rogers J, Lambers Heerspink HJ, Gumbo T, Vis P, Watkins P, Morrison T, Gillespie W, Gordon MF, Stephenson D, Hanna D, Pfister M, Lalonde R, Colatsky T. Journal of Pharmacokinetics and Pharmacodynamics, 2014 Dec;41(6):545-52. doi: 10.1007/s10928-014-9390-0.

Web-based software for real-time simulation-assisted trial design in Alzheimer’s disease

Polhamus DG, Kang J, Rogers JA, and Gastonguay MR. Presented at the 7th Annual Clinical Trials on Alzheimer’s Disease (CTAD), November 2014.

Establishing a priori identifiability of target mediated drug disposition models

Eudy RJ and Gastonguay MR. Presented at the 5th American Conference on Pharmacometrics (ACoP), Las Vegas, NV, October 2014.

Self-auditing data tables for R

Bergsma T and Pivirotto S.  Presented at the 5th American Conference on Pharmacometrics (ACoP), Las Vegas, NV, October 2014.

Elastic cloud computing in pharmacometrics: Usage data and strategies for efficient workflows

Knebel W, Gastonguay M, Polhamus D, Hane JT. Presented at the Annual Meeting of the Population Analysis Group in Europe (PAGE), Alicante, Spain; June 2014; Abstract I-55.

Research designs for proof-of-concept chronic pain clinical trials: IMMPACT recommendations

J. S. Gewandter, R. H. Dworkin, D. C. Turk, M. P. McDermott, R. Baron, M. R. Gastonguay, I. Gilron, N. P. Katz, C. Mehta, S. N. Raja, S. Senn, C. Taylor, P. Cowan, P. Desjardins, R. Dimitrova, R. Dionne, J. T. Farrar, D. J. Hewitt, S. Iyengar, G. W. Jay, E. Kalso, R. D. Kerns, R. Leff, M. Leong, K. L. Petersen, B. M. Ravina, C. Rauschkolb, A. S. C. Rice, M. C. Rowbotham, C. Sampaio, S. H. Sindrup, J. W. Stauffer, I. Steigerwald, J. Stewart, J. Tobias, R.-D. Treede, M. Wallace, and R. E. White.  Pain. 2014 Sep;155(9):1683-95. doi: 10.1016/j.pain.2014.05.025. Epub 2014 May 24.

A cloud-based cluster computing platform for pharmacometric applications

Bergsma T, Knebel W, Polhamus D, Hane JT, Gastonguay MR. Presented at the 4th American Conference on Pharmacometrics (ACoP), Ft. Lauderdale; May 2013.

Facilitating pharmacometric workflow with the metrumrg package for R

Bergsma TT, Knebel W, Fisher J, Gillespie WR, Riggs MM, Gibiansky L, Gastonguay MR. Comput Methods Programs Biomed. 2013 Jan;109(1):77-85.

Sumo: An authenticating web application with an embedded R session

Bergsma TT and Smith MS. The R Journal; June 2012, Vol. 4 Issue 1, p60-63.

From evidence synthesis to trial optimization: The adsim package for model-based simulation in Alzheimer’s disease

Polhamus D, Rogers J, Gillespie W, French J, and Gastonguay M.  Presented at the 21st Annual Meeting of the Population Approach Group Europe (PAGE), Venice, Italy, June 2012, Abstract 2580.

Building a scalable pharmacometrics platform in the cloud

Hane J and Kraut A.  Presented at BioIT World Conference and Expo, Boston, MA; April 23-25, 2012.

The value of evidence synthesis: Model-based meta-analysis based on the CAMD database, the ADNI AD cohort data, and literature meta-data

Rogers J, Polhamus D, Ito K, Qiu R, Gillespie W, Corrigan B. Presented at the 2012 American Society for Clinical Pharmacology and Therapeutics (ASCPT) Annual Meeting, National Harlbor, MD; March 2012.

Two guys and a credit card: Metrum’s Amazon cloud makeover – A case study in transferring a life sciences IT infrastructure fully into the cloud

Davies K.  Bio-IT World, Feb 14, 2012.

Full covariate models as an alternative to methods relying on statistical significance for inferences about covariate effects: A review of methodology and 42 case studies 

Gastonguay MR.  Presented at the 20th Annual Meeting of the Population Approach Group Europe (PAGE),  Athens, Greece,  June 2011. Abstract 2229.

Population pharmacokinetic/pharmacodynamic model of subcutaneous adipose 11β‐hydroxysteroid dehydrogenase type 1 (11β‐HSD1) activity after oral administration of AMG 221, a selective 11β‐HSD1 inhibitor

Gibbs JP, Emery MG, McCaffery I, Smith B, Gibbs MA, Akrami A, Rossi J, Paweletz K, Gastonguay MR, Bautista E, Wang M, Perfetti R, Daniels O.  J Clin Pharmacol. 51(6):830-41. June 2011.

Strategic data handling for pharmacometrics

Bergsma T. Presented at ACOP; April 2011; San Diego, CA.

Systematic review of versioned files for modeling and simulation quality control: the“review” R package

Bergsma T, Fisher J, Gastonguay MR, Hane J, Knebel W, Riggs MM, Rogers JA. Presented at ACOP; April 2011; San Diego, CA.

Population pharmacokinetic modeling of pantoprazole in pediatric patients from birth to 16 years

Knebel W, Tammara B, Udata C, Comer G, Gastonguay MR, Meng X.  J Clin Pharmacol. 51(3):333-45. March 2011.

A longitudinal dose-response model for the progression of alzheimers disease, based on a combination of summary-level and patient-level data

Rogers JA, Ito K, Gillespie WR, Corrigan BW, Gastonguay MR. Presented at the Fourth Annual Bayesian Biostatistics Conference, Houston, TX. 26–28 January 2011.

Quantifying uncertainty in predictions of hepatic clearance

Rogers JA, Wilbur J, Cole S, Bernhardt PW, Bupp JL, Lennon MJ, Langholz N, Steiner CP. Statistics in Biopharmaceutical Research. 3(4):515-525. (2011)

Development of mechanistic/multiscale/systems biology models in clinical pharmacology and translational research: do the challenges outweigh the potential benefits?

Riggs MM.  2010 AAPS Clinical Pharmacology and Translational Research (CPTR) Open Forum; 16 November 2010.

Pharmacometrics as a discipline is entering the “industrialization” phase: standards, automation, knowledge sharing, and training are critical for future success

Romero K, Corrigan B, Tornoe CW, Gobburu JV, Danhof M, Gillespie WR, Gastonguay MR, Meibohm B, Derendorf H. J Clin Pharmacol. 50(9 Suppl):9S-19S. September 2010.

Defining the future of pharmacometrics: the American Society of Pharmacometrics

Pfister M, Brundage RC, Gastonguay MR, Miller R, Tannenbaum SJ, D’Argenio DZ. J Clin Pharmacol. ;50(9 Suppl):158S. September 2010.

ACoP: the tools, carpenters, and architects building the discipline of pharmacometrics

Brundage RC, Pfister M, D’Argenio DZ, Gastonguay MR, Miller R, Tannenbaum SJ. J Clin Pharmacol. 50(9 Suppl):7S-8S. September 2010.

Comparison of MCMC simulation results using NONMEM 7 or WinBUGS with BUGSModelLibrary

Gastonguay MR, Gillespie WR, Bauer RJ. Presented at PAGE 2010. Berlin, Germany. 8–11 June 2010

Utilizing NONMEM 7 and the intel fortran compiler in a distributed computing environment

Knebel W, Bergsma TT, Dagdigian C, Hane J, Gastonguay MR. Presented at PAGE 2010, 19th Meeting, Berlin, Germany, June 8–11, 2010.

Predicting nonlinear changes in BMD over time using a physiologically-based mathematical model

Peterson MC and Riggs MM. Presented at American Association of Pharmaceutical Scientists National Biotechnology Conference, Update on Quantitative Systems and Disease Models for Biologics. Mini–Symposium. San Francisco, CA; May 2010.

Population pharmacokinetics of dexmedetomidine in infants after open heart surgery

Su F, Nicolson SC, Gastonguay MR, Barrett JS, Adamson PC, Kang DS, Godinez RI, Zuppa AF. Anesth Analg. 110(5):1383-92. May 2010.

Multiscale modeling: the quantitative integration of systems biology, clinical pharmacology and translational research

Riggs MM. Presented at American Association of Pharmaceutical Scientists National Biotechnology Conference, Update on Quantitative Systems and Disease Models for Biologics. Mini–Symposium. San Francisco, CA; May 2010.

An issue in controlling the type 1 error rate with adaptive designs using time-to-event endpoints

Rogers JA. Presented at 3rd Annual FDA/MTLI Medical Device and IVD Statistics Workshop. 28 April 2010.

Comparative performance of bayesian markov chain monte carlo and maximum likelihood population estimation methods when applied to nonlinear pharmacokinetics of monoclonal antibodies

Dirks N, Gastonguay MR, Gillespie WR, Knebel W, Riggs MM, Panetta JC, and Meibohm B. Presented at ASCPT 111th Annual Meeting, March 17-20, 2010.

Exposure-response modeling and clinical trial simulation of the effect of tolterodine on QT intervals in healthy volunteers

Sweeney KR, Gastonguay MR, Benincosa L, Cronenberger CL, Glue P, Malhotra BK. Drug Discov Ther. 4(1):44-53. February 2010.

Quantitative assessment of exposure–response relationships for the efficacy and tolerability of varenicline for smoking cessation

Ravva JP, Gastonguay MR, French JL, Tensfeldt TG, and Faessel HM. Clinical Pharmacology & Therapeutics. 87(3):336-44. January 2010.

Population pharmacokinetics of intravenous ondansetron in oncology and surgical patients aged 1-48 months

Mondick JT, Johnson BM, Haberer LJ, Sale ME, Adamson PC, Coté CJ, Croop JM, Russo MW, Barrett JS, Hoke JF. Eur J Clin Pharmacol. 66(1):77-86. January 2010.

The impact of missing data on model evaluation

Gastonguay MR. Presented at ACOP 2009. 6 October 2009; Mashantucket, CT.

Population dose-response model for ADAS-cog ccores in patients with alzheimers disease by meta-analysis of a mixture of summary and individual data

Gillespie WR, Rogers JA, Ito K, Gastonguay MR. Presented at ACOP 2009. October 4-7, 2009; Mashantucket, CT.

Prototype model library for bayesian pharmacokinetic/pharmacodynamic (PKPD) modeling in WinBUGS

Gillespie B, Gastonguay MR. Presented at ACOP 2009. October 4-7, 2009; Mashantucket, CT.

A systems biology model to describe long-term bone remodeling effects of estrogen in menopausal and postmenopausal women

Riggs MM, Peterson MC, Gastonguay MR. Presented at ACOP 2009. October 4-7, 2009; Mashantucket, CT.

Preliminary population pharmacokinetic modeling of PF-04360365, a humanized anti-amyloid monoclonal antibody, in patients with mild-to-moderate alzheimer’s disease

Nicholas T, Knebel W, Gastonguay MR, Bednar MM, Billing B, Landen JW, Kupiec JW, Corrigan B, Laurencot R, Zhao Q. Poster presented at the ICAD 2009 Annual Meeting; July 11–16, 2009; Vienna, Austria.

Population dose-response model for ADAS-cog scores in patients with alzheimer’s disease by meta-analysis of a mixture of summary and individual data

Gillespie B, Rogers JA, Ito K, Gastonguay MR. ASCPT 110th Annual Meeting, March 18-21, 2009; Washington D.C.

Population pharmacokinetic modeling of epoetin delta in pediatric patients with chronic kidney disease

Knebel W, Palmen M, Dowell JA, Gastonguay M. J Clin Pharmacol. 48(7):837-48. July 2008.

Population pharmacokinetic modeling of fosamprenavir in pediatric HIV-infected patients

Fisher J, Gastonguay MR, Knebel W, Gibiansky L, Wire MB. Poster presented at the American Conference on Pharmacometrics. March 9-12 2008; Tucson, Arizona.

Use of rpad, an open-source, interactive, web-based analysis program, for visualization during model-based drug development of adipiplon, a GABAA receptor partial agonist under investigation for the treatment of insomnia

Riggs MM, Bergsma TT, Gillespie WR, Gastonguay MR, Sprenger KJ. Poster presented at the American Conference on Pharmacometrics. March 9-12 2008; Tucson, Arizona.

Open source software tools for parallel computation of multiple MCMC chains with WinBUGS

Gillespie WR, Gastonguay MR, Knebel W, Georgalis G. Poster presented at the American Conference on Pharmacometrics. March 9-12 2008; Tucson, Arizona.

Facilitating the pharmacometrics work-flow with the mItools r package

Knebel W, Bergsma T, Fisher J, Georgalis G, Gibiansky L, Gillespie WR, Riggs MM, Gastonguay MR. Poster presented at the American Conference on Pharmacometrics. March 9-12 2008; Tucson, Arizona.

Bayesian approaches to mixed effects models for ordered categorical data

Gillespie WR, Gastonguay MR, Knebel W. Presented at the AAPS Annual Meeting; November 2007; San Diego, CA.

Population pharmacokinetic-pharmacodynamic modeling of istradefylline in patients with parkinson’s disease

Knebel W, Rao N, Bergsma T, Gastonguay M, Mori A, Uchimura T, Allenby K, Dvorchik B, Sussman N, Chaikin P. Presented at ACCP; October 14-17, 2007; Denver, CO.

Quantitative assessment of exposure-response relationships for the efficacy and tolerability of varenicline for smoking cessation

Rawa P, Faessel H, Gastonguay MR, Tensfeldt TG, Reeves K. Clin Pharmacol Ther. 81(S1) March 2007; Abstract PII-73: S72.

Exposure-response (PK-PD) applied to model-based drug development: A case study of drug x

Riggs M. FDA/Industry Statistics Workshop. 29 September 2006; Washington D.C.; Parallel Session 14: Case Studies in Modeling and Simulation, Abstract.

Development and evaluation of a population pharmacokinetic-pharmacodynamic model of darbepoetin alfa in patients with nonmyeloid malignancies undergoing multicycle chemotherapy

Agoram B, Heatherington AC, Gastonguay MR. AAPS Journal. 8(3), September 2006. doi: 10.1208/aapsj080364

Acknowledging and incorporating uncertainty in model-based inferences

Gastonguay MR, Gibiansky L. Presented at the ECPAG Conference. July 24-26, 2006; Rockville, MD; Workshop Poster Session, Abstract.

Acknowledging parameter uncertainty in the simulation-based design of an actinomycin-D pharmacokinetic study in pediatric patients with Wilms’ Tumor or rhabdomyosarcoma

Mondick JT, Gibiansky L, Gastonguay MR, Veal GJ, Barrett JS. Presented at PAGE 2006. June 14-16, 2006; Brugge/Bruges, Belgium; Abstract 938.

R/NONMEM Toolbox for simulation from posterior parameter (uncertainty) distributions

Gibiansky L and MR Gastonguay. Presented at PAGE 2006. June 14-16, 2006; Brugge/Bruges, Belgium; Abstract 958.

Acknowledging parameter uncertainty by simulating from posterior distributions with NONMEM and R

Gastonguay MR, Gibiansky L. Presented at the MUFPADA Annual Meeting. May 2-3, 2006; Ann Arbor, MI; Abstract.

NMQual: A tool to automate installation and facilitate qualification of NONMEM

Knebel B, Bergsma T, Gibiansky L, Hane JT, Gastonguay MR. Presented at PAGE Annual Meeting. June 16-17, 2005; Pamplona, Spain; Abstract 779.

Modeling and simulation guided design of a pediatric population pharmacokinetic trial for hydromorphone

Gastonguay MR, El-Tahtawy A. The AAPS Journal. 7(S2), June 2005. Abstract W5318.

Effect of NONMEM minimization status and number of replicates on bootstrap parameter distributions for population pharmacokinetic models: a case study

Gastonguay MR, El-Tahtawy A. Clinical Pharmacology and Therapeutics. 77(2), P2-P2; February 5, 2005.

Population pharmacokinetic model of sedative doses of GPI 15715 and propofol liberated from GPI15715

Gibiansky E, Gibiansky L, Enriquez J. Clinical Pharmacology and Therapeutics. 77(2), P48-P48; February 5, 2005.

NONMEM Non-influential correlated ETAs bug and how to fix it

Gibiansky L. Presented at AAPS Annual Meeting: PPDM Poster-Podium Session, November 10, 2004; Baltimore, MD.

Estimation and prediction of chaotic pharmacodynamic systems using nonlinear mixed-effects models: the butterfly effect

Gastonguay MR, Bies R. The AAPS Journal. 6(S1) (2004); Abstract W4353, 2004.