Other

Bayesian data analysis using Stan/Torsten for pharmacometric applications

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

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.

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.

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.

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.

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.

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.

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

Lalovic B, Rogers JA, 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

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.

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. 7:117-25. 16 March 2011.

Clinical trial simulation to compare adaptive and fixed designs for a phase 3 clinical trial of Nacystelyn® (L-Lysine-N-acetyl-L-cysteinate) for cystic fibrosis

Rogers JA, Riggs MM, Coffiner M, Gillespie WR, Burford R, Vanderbist F, De Niet S, Gastonguay MR. ACOP 2009. October 4–7, 2009; Mashantucket, CT.

Model-based drug development: optimization of AQUAVAN® injection dosing for minimal-to-moderate sedation

Gibiansky E, Gibiansky L. Presented at PAGE 2006. June 14-16, 2006; Brugge/Bruges, Belgium; Abstract 959.

The importance of the simulation expectation as a goodness of fit diagnostic for categorical population pharmacodynamic models

Gastonguay MR, Hane JT. The AAPS Journal. 6(S1) (2004); Abstract W4355.

A full model estimation approach for covariate effects: inference based on clinical importance and estimation precision

Gastonguay MR. The AAPS Journal. 6(S1) (2004); Abstract W4354.