All Publications

A model of the effects of GI disease and diet on child body composition in order to improve outcomes in those suffering from malnutrition

Eudy-Byrne R. Presented at the 17th American Pediatrics Healthcare & Infectious Diseases Congress, Vancouver, Canada, 28 June 2018.

Real world evidence and model-informed drug development – an antidiabetic drug cardiovascular outcome case study

Meng Z, Rogers J, Sidi J, Tang Q, Patel D, Gaudel-Dedieu N, and Delvart D. Presented at the Annual Meeting of the Population Approach Group in Europe (PAGE) Montreux, Switzerland, May 2018. Abstract I-76.

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

Population pharmacokinetic – pharmacodynamic analysis to characterize the effect of empagliflozin on renal glucose threshold in patients with type 1 diabetes mellitus

Mondick J, Riggs M, Kaspers S, Soleymanlou N, Marquard J, Nock V. J Clin Pharmacol. 58 (5): 640-649; May 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.

Corrigendum: Exposure-efficacy relationships for vedolizumab induction therapy in patients with ulcerative colitis or Crohn’s disease

Rosario M, French JL, Dirks NL, Sankoh S, Parikh A, Yang H, Danese S, Colombel JF, Smyth M, Sandborn WJ, Feagan BG, Reinisch W, Sands BE, Sans M, Fox I. J Crohns Colitis 12 (4): 510. 2018 Mar 28.

Exposure–response analyses of trastuzumab emtansine in patients with HER2-positive advanced breast cancer previously treated with trastuzumab and a taxane

Li C, Wang B, Chen SC, Wada R, Lu D, Wang X, Polhamus D, French J, Vadhavkar S, Strasak A, Smitt M, Joshi A, Samant M, Quartino A, Jin J, Girish S. Cancer Chemotherapy and Pharmacology 80 (6): 1079–90. December 2017.

A model of fracture risk used to examine the link between bone mineral density and the impact of different therapeutic mechanisms on fracture outcomes in patients with osteoporosis

Eudy-Byrne RJ, Gillespie W, Riggs MM. Gastonguay MR. J Pharmacokinet Pharmacodyn (2017).  First online 28 Oct 2017. https://doi.org/10.1007/s10928-017-9551-z

Model-based clinical pharmacology profiling and exposure-response relationships of the efficacy and biomarker of lebrikizumab in patients with moderate-to-severe asthma

Zhu R, Zheng Y, Dirks NL, Vadhavkar S, Jin JY, Peng K, Holweg CTJ, Olsson J, Matthews JG, Putnam WS. Pulmonary Pharmacology & Therapeutics 46: 88–98. October 2017.

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.

Population pharmacokinetics and exposure–response of trastuzumab emtansine in advanced breast cancer previously treated with ≥2 HER2-targeted regimens

Chen S-C, Quartino A, Polhamus D, Riggs M, French J, Wang X, Vadhavkar S, Smitt M, Hoersch S, Strasak A, Jin JY, Girish S, and Li C. Br J Clin Pharmacol, 2017 Jul 21.

Time-to-event analysis of polatuzumab vedotin-induced peripheral neuropathy to assist in the comparison of clinical dosing regimens

Lu D, Gillespie WR, Girish S, Agarwal P, Li C, Hirata J, Chu YW, Kagedal M, Leon L, Maiya V, Jin JY. CPT: Pharmacometrics & Systems Pharmacology 6 (6): 401–8. June 2017.

Quantitative disease progression model of α-1 proteinase inhibitor therapy on computed tomography lung density in patients with α-1 antitrypsin deficiency

Tortorici MA, Rogers JA, Vit O, Bexon M, Sandhaus R A, Burdon J, Chorostowska-Wynimko J, Thompson P, Stocks J, McElvaney NG, Chapman KR, and Edelman JM. Br J Clin Pharmacol, June 2017.  doi: 10.1111/bcp.13358.

Population pharmacokinetics of morphine in patients with nonalcoholic steatohepatitis (NASH) and healthy adults

Pierre V, Johnston C, Ferslew B, Brouwer K, Gonzalez D.  CPT: Pharmacometrics & Systems Pharmacology. 2017;6(5):331-339. doi:10.1002/psp4.12185.

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.

Population PK modeling and target attainment simulations to support dosing of ceftaroline fosamil in pediatric patients with acute bacterial skin and skin structure infections and community-acquired bacterial pneumonia

Riccobene TA, Khariton T, Knebel W, Das S, Li J, Jandourek A, Carrothers TJ, Bradley JS.  The Journal of Clinical Pharmacology, March 2017; 57: 345–355. doi: 10.1002/jcph.809

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.

Population pharmacokinetic and pharmacodynamic analysis of buprenorphine for the treatment of neonatal abstinence syndrome

Moore JN, Gastonguay M, Adeniyi-Jones S, Moodey DE, Kraft WK.  Poster presented at: American Society for Clinical Pharmacology and Therapeutics (ASCPT) Annual Meeting, March 2017, Washington, DC; Abstract PII-099.

Population pharmacokinetic modeling of intravenous asparaginase erwinia chrysanthemi: Impact of varied infusion rates on exposure

Zomorodi K, Dumas T, Berry S, Johnston C, and Eller M. Blood, Dec 2016, 128 (22) 1631

Population pharmacokinetics (PK) and exposure-response (E-R) analysis of trastuzumab emtansine (T-DM1) in patients with HER2+ metastatic breast cancer (MBC) who have received at least two prior regimens of HER2-directed therapy

Chen SC, Quartino AL, Polhamus D, Riggs MM, French JL, Wang X, Vadhavkar S, Smitt M, Hoersch S, Strasak A, Chernyukhin N, Jin JY, Girish S, Li C.  Abstract in Proceedings of the 2016 San Antonio Breast Cancer Symposium; 2016 Dec 6-10; San Antonio, TX. Cancer Res 2017;77(4 Suppl):Abstract P4-21-26.

Animal-to-human dose translation of obiltoxaximab for treatment of inhalational anthrax under the US FDA animal rule.

Nagy CF, Mondick J, Serbina N, Casey LS, Carpenter SE, French J, Guttendorf R.  Clinical And Translational Science, 2016 Dec; 10: 12–19.

Systems pharmacology model development to provide physiologically based interpretation and drug development decision support in osteoporosis and other bone mineral-related diseases

Riggs, M.  Presented at Pharmacology 2016, annual meeting of the British Pharmacological Society, London, December 2016.

Crenezumab exposure–response across AD endpoints supports a higher dose for phase 3

Polamus D, Rogers J, Paul R, Kshirsagar S, Sahasranaman S, Jin JY, Quartino AL.  Presented at the 9th Annual Clinical Trials on Alzheimer’s Disease (CTAD), December 2016.

Extension of multi-scale systems pharmacology model to evaluate effect of vitamin D3 pharmacokinetics on bone health

Ocampo-Pelland AS, Gastonguay MR, Riggs MM.  Presented at the 7th American Conference on Pharmacometrics (ACoP), Bellevue, WA; October 2016.

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.

Efficacy projection of obiltoxaximab for treatment of inhalational anthrax across a range of disease severity

Yamamoto BJ, Shadiack AM, Carpenter S, Sanford D, Henning LN, O’Connor E, Gonzales N, Mondick J, French J, Stark GV, Fisher AC, Casey LS, Serbina NV. Antimicrob Agents Chemother 60:5787–5795. doi:10.1128/AAC.00972-16

Vedolizumab efficacy exposure–response relationship for ulcerative colitis patients (GEMINI I) based on causal inference analysis

Gastonguay MR, Lasch K, Barocas M, Rosario M, Wilbur JD, Dirks NL, Osterman MT.  Presented at the American College of Gastroenterology Annual Meeting, 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.

Pharmacokinetics (PK) and exposure-response (E-R) analysis of Kadcyla (K) as a single agent or in combination with Perjeta (P) in patients with human epidermal growth factor receptor 2 positive (HER2+) metastatic breast cancer (MBC) who have not received prior chemotherapy for their metastatic disease

Lu D, Li C, Polhamus D, French JL, Riggs MM, Agarwal P, Chen SC, Wang X, Smitt M, Patre M, Strasak A, ChernyukhinN , Quartino AL, Jin JY, Girish S.  Presented at the 7th American Conference on Pharmacometrics (ACoP), Bellevue, WA; October 2016.

Penetration of ceftaroline into the epithelial lining fluid of healthy adult subjects

Riccobene TA, Pushkin R, Jandourek A, Knebel W, Khariton T.  Antimicrob Agents Chemother. 2016 Sep 23;60(10):5849-57.

Prototype Stan functions for Bayesian pharmacometric modeling

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

A mathematical model to quantify links between bone mineral density, patient factors and therapeutic interventions on fracture risk in patients with osteoporosis

Eudy-Byrne RJ, Gillespie WR, Riggs MM, Gastonguay MR.  Poster presented at: American Society for Bone and Mineral Research Annual Meeting; September 2016.

Population pharmacokinetics and exposure-response (efficacy and safety/tolerability) of empagliflozin in patients with type 2 diabetes

Baron KT, Macha S, Broedl UC, Nock V, Retlich S, Riggs M.  Diabetes Ther. 2016 Sep;7(3):455-71.

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.

Modeling Duchenne muscular dystrophy (DMD) disease progression as assessed by the 6-minute walk test.

Hajjar J, Fisher J, Gastonguay MR.  Presented at the Annual Meeting of 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.

Dexmedetomidine pharmacology in neonates and infants after open heart surgery

Su F, Gastonguay MR, Nicolson SC, DiLiberto M, Ocampo-Pelland A, Zuppa AF. Anesth Analg. 2016 May;122(5):1556-66.

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.

Mixed-effects modelling to quantify the effect of empagliflozin on renal glucose reabsorption in patients with type 2 diabetes

Mondick J, Riggs M, Sasaki T, Sarashina A, Broedl UC, Retlich S. Diabetes Obes Metab. 2016 Mar;18(3):241-8.

Dose-response and exposure-response modeling of alpha-1 proteinase inhibitor (A1-PI) in patients with A1-PI deficiency based on RAPID and RAPID extension trials

Rogers JA, Tortorici MA, Viti O, Brexon M, Sandhaus RA, Burdon J, Piitulainen E, Seersholm N, Stocks J, McElvaney NG, Chapman KR, Edelman JM.  Presented at the American Society for Clinical Pharmacology and Therapeutics (ASCPT) Annual Meeting, San Diego, CA, March 2016.

Systematic review and meta-analysis of serious infections with tofacitinib and biologic disease-modifying antirheumatic drug treatment in rheumatoid arthritis clinical trials

Strand V, Ahadieh S, French J, Geier J, Krishnaswami S, Menon S, Checchio T, Tensfeldt TG, Hoffman E, Riese R, Boy M, Gómez-Reino JJ.  Arthritis Res Ther. 2015 Dec 15;17:362.

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

PK-PD analysis of PASI with data at boundary: BI 655066, an anti-IL-23A mAb for the treatment of psoriasis

Lalovic B, Rogers J, French J, Flack M. PK-PD Analysis of PASI with Data at Boundary: BI 655066, an Anti-IL-23A mAb for the Treatment of Psoriasis.  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.

Population pharmacokinetic modeling of guanfacine in pediatric patients

Knebel W, Corcoran M, Ermer J, Gastonguay MR.  Clinical Pharmacokinetics (2015) 54: 875. doi:10.1007/s40262-015-0245-7

Connecting the dots: Linking osteocyte activity and therapeutic modulation of sclerostin by extending a multiscale systems model

Eudy RJ, Gastonguay MR, Baron KT, and Riggs MM.  CPT: Pharmacometrics & Systems Pharmacology. 2015;4(9):527-536. doi:10.1002/psp4.12013.

Population pharmacokinetics-pharmacodynamics of vedolizumab in patients with ulcerative colitis and Crohn's disease

Rosario M, Dirks NL, Gastonguay MR, Fasanmade AA, Wyant T, Parikh A, Sandborn WJ, Feagan BG, Reinisch W, Fox I.  Aliment Pharmacol Ther. 2015 Jul;42(2):188-202.

Malabsorption blood test: Assessing fat absorption in patients with cystic fibrosis and pancreatic insufficiency

Mascarenhas MR, Mondick J, Barrett JS, Wilson M, Stallings VA, Schall JI.  The Journal of Clinical Pharmacology, 55: 854–865. doi:10.1002/jcph.484

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.

Sclerostin-mediated osteocyte control in bone remodeling: Extension of a multiscale systems model to consider new therapies for osteoporosis

Eudy RJ, Gastonguay MR, Baron KT, Riggs MM.  Presented at the Annual Meeting of the Population Group in Europe (PAGE), Hersonnisos, Greece; June 2015.

Altered morphine glucuronide and bile acid disposition in patients with nonalcoholic steatohepatitis

Ferslew B, Johnston C, Tsakalozou E, Bridges A, Paine M, Jia W, Stewart P, Barritt A and Brouwer K. Clinical Pharmacology and Therapeutics, 97: 419–427. doi:10.1002/cpt.66

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 of the exposure-response and dropout pattern of guanfacine extended-release in pediatric patients with ADHD

Knebel W, Rogers J, Polhamus D, Ermer J, Gastonguay MR. Journal of Pharmacokinetics and Pharmacodynamics, Feb 2015, Volume 42, Issue 1, pp 45–65. doi:10.1007/s10928-014-9397-6

Pharmacokinetic-pharmacodynamic modeling of the effect of varenicline on nicotine craving in adult smokers

P. Ravva, M. R. Gastonguay, H. M. Faessel, T. C. Lee, and R. Niaura. Nicotine & Tobacco Research, Volume 17, Issue 1, 1 January 2015, Pages 106–113.

Population pharmacokinetics of ε-aminocaproic acid in adolescents undergoing posterior spinal fusion surgery

Stricker PA, Gastonguay MR, Singh D, Fiadjoe JE, Sussman EM, Pruitt EY, Goebel TK, and Zuppa AF.  BJA: British Journal of Anaesthesia, 114(4), 689–699. http://doi.org/10.1093/bja/aeu459

Predicted impact of various clinical practice strategies on cardiovascular risk for the treatment of hypertension: a clinical trial simulation study

Jin Y, Bies R, Gastonguay MR, Wang Y, Stockbridge N, Gobburu J, Madabushi R. J Pharmacokinet Pharmacodyn. 2014 Dec;41(6):693-704. doi: 10.1007/s10928-014-9394-9

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.

Exposure−response modelling for empagliflozin, a sodium glucose cotransporter 2 (SGLT2) inhibitor, in patients with type 2 diabetes

Riggs MM, Seman LJ, Staab A, MacGregor TR, Gillespie W, Gastonguay MR, Woerle HJ, Macha S.  Br J Clin Pharmacol. 2014 Dec;78(6):1407-18. doi: 10.1111/bcp.12453.

Population pharmacokinetics of brodalumab in healthy adults and adults with psoriasis from single and multiple dose studies

Endres CJ, Salinger DH, Köck K, Gastonguay MR, Martin D, Klekotka P, Nirula A, and Gibbs MA. The Journal of Clinical Pharmacology, 54(11): 1230–1238, November 2014. doi:10.1002/jcph.334.

Altered fasting and postprandial serum bile acids in patients with non-alcoholic steatohepatitis (NASH)

Ferslew BC, Johnston CK, Tsakalozou EF, Su MI, Xie GU, Jia WE, Brouwer KLR and Barritt AS. Presented at the American Association for the Study Of Liver Diseases Annual Meeting, Boston, MA, November 2014; Abstract 831.

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.

Exposure-response modeling in oncology: technical challenges and proposed solutions

Jonathan French. Presented at the 5th American Conference on Pharmacometrics (ACoP), Las Vegas, NV, October 2014.

Population pharmacokinetic (PPK) modeling and simulation to support pediatric dose selection of ceftaroline fosamil (CPT-F) in children aged 28 days to 12 years

Khariton T, Riccobene T, Knebel W, O’Neal T, Ghahramani P. 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.

Population pharmacokinetic/pharmacodynamic modeling of guanfacine effects on QTc and heart rate in pediatric patients

W. Knebel, J. Ermer, J. Purkayastha, P. Martin, and M. R. Gastonguay.  The AAPS Journal. 2014;16(6):1237-1246. doi:10.1208/s12248-014-9645-0.

An integrated natural disease progression model of nine cognitive and biomarker endpoints in patients with Alzheimer’s Disease

Angelica Quartino, Dan Polhamus, James Rogers, and Jin Jin. Presented at the Population Approach Group Europe (PAGE), Alicante, 2014. Abstract 3187.

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.

PKPD modeling of predictors for adverse effects and overall survival in sunitinib-treated patients with GIST

Hansson EK, Ma G, Amantea MA, French J, Milligan PA, Friberg LE, and Karlsson MO. CPT: Pharmacometrics & Systems Pharmacology. 2013;2(12):e85-. doi:10.1038/psp.2013.62.

PKPD modeling of VEGF, sVEGFR-2, sVEGFR-3, and sKIT as predictors of tumor dynamics and overall survival following sunitinib treatment in GIST

Hansson EK, Amantea MA, Westwood P, Milligan PA, Houk BE, French J, Karlsson MO and Friberg LE. CPT: Pharmacometrics & Systems Pharmacology. 2013;2(11):e84-. doi:10.1038/psp.2013.61

Clinical dementia rating modeling and simulation: Joint progression of CDR and biomarkers in the ADNI cohort

Polhamus DG, Rogers JA, Gillespie WR, French J. Presented at the Alzheimer’s Association International Conference (AAIC),  2013.

Mathematical modeling of systemic and hepatic disposition of morphine and morphine glucuronides in nonalcoholic steatohepatitis to inform study design

Johnston CK, Ferslew BC, Barritt AS, Brouwer KL. Presented at the American Association of Pharmaceutical Scientists Annual Meeting, San Antonio, TX, November 2013.

Extensions of a multiscale systems pharmacology model of bone mineral balance and its regulation of bone health

Riggs MM. Presented at Sunrise Session: Integration of Systems Modeling in Clinical Development: Successes, Challenges, and Future Outlook at the American American Society for Clinical Pharmacology and Therapeutics Annual Meeting, 2013.

Systems pharmacology model development to provide physiologically-based interpretation and drug development decision support in osteoporosis and other bone-related diseases

Riggs M.  Presented at the Annual Meeting of the American Society for Clinical Pharmacology and Therapeutics, 2013.

Pharmacokinetic modeling of the relationship between sustained virological response and plasma concentrations of faldaprevir or bi-207127 in hcv gt1-infected patients in sound-c2

Olson S, Baron K, Riggs M, Bocher WO, Mensa FJ.  Journal of Hepatology, 58:S492–S493.

An evaluation of calcilytic effects on parathyroid hormone and bone mineral density response using a physiologically-based, multiscale systems pharmacology model

Kyle T. Baron, Matthew M. Riggs, Ryoko Sawamura, Takako Shimizu, Fumihiko Okada, Jin Zhou, Takahiro Shibayama, Mendel Jansen. Presented at the American Society of Bone and Mineral Research (ASBMR), October, 2013.

Population pharmacokinetics of empagliflozin, a sodium glucose cotransporter 2 inhibitor, in patients with type 2 diabetes

Riggs MM, Staab A, Seman L, MacGregor TR, Bergsma TT, Gastonguay MR, Macha S.  The Journal of Clinical Pharmacology. 2013 Oct;53(10):1028-38. doi:10.1002/jcph.147

Can methods based on existing models really aid decision making in non-small-cell lung cancer (NSCLC) trials?

Presented at the Annual Meeting of the Population Approach Group Europe (PAGE), Glasgow; June, 2013. Abstract A-06.

Population pharmacokinetics of epsilon-aminocaproic acid in infants undergoing craniofacial reconstruction surgery

Stricker PA, Zuppa AF, Fiadjoe JE, Maxwell LG, Sussman EM, Pruitt EY, Goebel. TK, Gastonguay MR, Taylor JA, Bartlett SP, Schreiner MS.  Br J Anaesth. 2013 May;110(5):788-99. doi: 10.1093/bja/aes507

Population pharmacokinetics of atorvastatin and its active metabolites in children and adolescents with heterozygous familial hypercholesterolemia: Selective use of informative prior distributions from adults

Knebel W, Gastonguay MR, Malhotra B, El-Tahtawy A, Jen F and Gandelman K.  J Clin Pharmacol. 2013 May; 53 (5): 505-16. doi: 10.1002/jcph.66.

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.

Opportunities and challenges of MBMA in oncology

French J. Presented at the 4th American Conference on Pharmacometrics (ACoP), Ft. Lauderdale; May 2013.

A novel model-based meta-analysis to indirectly estimate the comparative efficacy of two medications: an example using DPP-4 inhibitors, sitagliptin and linagliptin, in treatment of type 2 diabetes mellitus

Gross JL, Rogers J, Polhamus D, Gillespie W, Friedrich C, Gong Y, Monz BU, Patel A, Staab A, Retlich S. BMJ Open. 5 March 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.

Predicting nonlinear changes in bone mineral density over time using a multiscale systems pharmacology model

Peterson MC and Riggs MM. CPT Pharmacometrics Syst Pharmacol. 2012 Nov; 1(11): e14. Published online 2012 Nov 14. doi: 10.1038/psp.2012.15

Integrated pharmacometrics and systems pharmacology model-based analyses to guide GnRH receptor modulator development for management of endometriosis

Riggs MM, Bennetts M, van der Graaf PH, and Martin SW.  CPT Pharmacometrics Syst Pharmacol. 2012 Oct; 1(10): e11. Published online 2012 Oct 17. doi: 10.1038/psp.2012.10

Novel model-based meta-analysis to estimate comparative efficacies of 2 drugs: An example using the DPP-4 inhibitors linagliptin and sitagliptin in type 2 diabetes mellitus

Gross JL, Rogers J, Polhamus D, Gillespie W, Patel S, Friedrich C, Gong Y, Monz B, Staab A, Retlich S.  American Diabetes Association 72nd Scientific Sessions, 2012.

Population pharmacokinetic-pharmacodynamic analysis of istradefylline in patients with Parkinson disease

Knebel W, Rao N, Uchimura T, Mori A, Fisher J, Gastonguay MR, and Chaikin P. The Journal of Clinical Pharmacology, 2012; 52: 1468–1481. doi:10.1177/0091270011420566.

Combining patient-level and summary-level data for Alzheimer’s disease modeling and simulation: A beta regression meta-analysis

Rogers JA, Polhamus D, Gillespie WR, Ito K, Romero K, Qiu R, Stephenson D, Gastonguay MR, Corrigan B. J Pharmacokinet Pharmacodyn. October 2012, Volume 39, Issue 5, pp 479-498.

Qualification of a physiologically-based model for predicted bone marker and bone mineral density changes associated with denosumab treatment

Riggs MM, Baron KT, Plan EL, Gastonguay MR. Presented at American Society of Bone Mineral Research (ASBMR) Annual Meeting, Minneapolis, MN; October 14, 2012 (Abstract SU0363).

Modeling and simulation of guanfacine extended-release to support pediatric trial design

Knebel W, Rogers J, Polhamus D, Youcha S, White C, Ermer J, and Gastonguay M. American Academy of Child and Adolescent Psychiatry, 59th Annual Meeting. 2012.

Avagacestat (BMS-708163) exposures and study discontinuations in patients with mild-to-moderate Alzheimer’s disease

Abu Tarif M, Kaplita S, Berman RM, Coric V, Baron K.  Presented at the Alzheimer’s Association International Conference (AAIC), Vancouver, BC, July 2012.

Model-based analysis to support strategic decision making: A case study from the development of a 5HT6 antagonist for the treatment of Alzheimer’s disease

Rogers J, Lockwood P, Polhamus D, Brault Y, Desmet A, Ito K, Romero K, Qiu R, Gillespie W, Corrigan B, Gastonguay M.  Presented at the Alzheimer’s Association International Conference (AAIC), Vancouver, BC, July 2012.

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.

Misclassification and discordance of measured blood pressure from patient’s true blood pressure in current clinical practice: A clinical trial simulation case study

Jin Y, Bies R, Gastonguay MR, Stockbridge N, Gobburu J, Madabushi R.  J Pharmacokinet Pharmacodyn. 2012 Jun;39(3):283-94.

Bayesian joint modeling of bone mineral density and repeated time-to-fracture event for multiscale bone systems model extension

Plan EL, Baron KT, Gastonguay MR, French JL, Gillespie WR, and Riggs MM. Presented at the 21st Annual Meeting of the Population Approach Group Europe (PAGE), Venice, Italy, 2012, Abstract 2592.

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.

Model-based meta-analysis comparison of the effects of linagliptin and sitagliptin on HbA1c levels in patients with type 2 diabetes mellitus

Rogers J, Polhamus D, Gillespie W, Friedrich C, Staab A, and Retlich S. Presented at the 21st Annual Meeting of the Population Approach Group Europe (PAGE), Venice, Italy, June 2012, Abstract 2448.

Systematic extension of a physiologic model of bone and calcium homeostasis

Riggs MM. . Presented at the AAPS Biotechnology Conference, San Diego, CA; May 22, 2012.

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.

Population pharmacokinetics and exposure-response of albinterferon alfa-2b

Riggs MM, Bergsma TT, Rogers JA, Gastonguay MR, Subramanian GM, Chen C, Devalaraja M, Corey AE, Sun H, Yu J, and Stein DS. The Journal of Clinical Pharmacology, 52: 475–486, April 2012. doi:10.1177/0091270011399576

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.

Affiliation between the American Society of Pharmacometrics and the Journal of Pharmacokinetics and Pharmacodynamics.

D’Argenio DZ, Gastonguay MR, Brundage RC, Miller R, Tannenbaum SJ, Pfister M. J Pharmacokinet Pharmacodyn. 2012 Feb;39(1):3.

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.

Multiscale physiology-based modeling of mineral bone disorder in patients with impaired kidney function

Riggs MM, Peterson MC, Gastonguay MR. The Journal of Clinical Pharmacology. 2012 Jan;52(1 Suppl):45S-53S. doi:10.1177/0091270011412967

 

Applying a multiscale physiologic system model to evaluate bone-related disease and therapeutic responses

Riggs MM. Presented at First Indiana Clinical and Translational Sciences Institute (CTSI) Symposium on Disease and Therapeutic Response Modeling. Indiana University – Purdue University Indianapolis; Indianapolis, IN; November 13, 2011.

Application of modeling and simulation to support clinical drug development decisions in Alzheimer’s disease

Gastonguay MR.  Presented at First Indiana Clinical and Translational Sciences Institute (CTSI) Symposium on Disease and Therapeutic Response Modeling. Indiana University – Purdue University Indianapolis; Indianapolis, IN; November 13, 2011.

Attenuation of vancomycin pharmacodynamics (PD) due to dense inoculum methicillin-resistant Staphylococcus aureus (MRSA)

Johnston CK, Tsuji BT.  Presented at the American College of Clinical Pharmacy (ACCP) Annual Meeting, Pittsburgh, PA, October 2011.

Population pharmacokinetics of pentobarbital in neonates, infants, and children after open heart surgery

Zuppa AF, Nicolson SC, Barrett JS, Gastonguay MR.  J Pediatr. 2011 Sep;159(3):414-419.e1-3.

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.

Performance of Cpred/Cobs concentration ratios as a metric reflecting adherence to antidepressant drug therapy

Feng Y, Gastonguay MR, Pollock BG, Frank E, Kepple GH, Bies RR.  Neuropsychiatr Dis Treat. 2011;7:117-25.