Publications | Peter Bonate

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Publications

1. Yamada A, Yang J, Bonate PL, Heo N, Poondru S. Population pharmacokinetic analysis of fluorouracil and oxaliplatin in the absence or presence of zolbetuximab in locally advanced unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma. Cancer Chemotherapy and Pharmacology 2025; 95: 89.

2. Yamada A, Takeuchi M, Komatsu K, Bonate PL, Poondru S, and Yang J. Population PK and Exposure‐Response Analyses of Zolbetuximab in Patients With Locally Advanced Unresectable or Metastatic G/GEJ Adenocarcinoma. Clinical and Translational Science 2025 July 2; 18(7): e70280.

3. Yamada A, Choules MP, Brightman FA, Takeshita S, Nakao S, Amino N, Nakayama T, Takeuchi M, Komatsu K, Ortega F, Mistry H, Orrell D, Chassagole C, and Bonate PL. A multiple-model-informed drug development approach for optimal regimen selection of an oncolytic virus in combination with pembrolizumab. CPT Pharmacometrics Systems Pharmacology14; 572-582, 2025.

4. Iwai M, Nielsen J, Miyagawa M, Patton M, Bonate PL, Wang X, Wojtkowski T, Sinn A, and Huang J. In Vitro evaluation of CYP‐mediated metabolism of fezolinetant and pharmacokinetic interaction between fezolinetant and fluvoxamine in healthy postmenopausal smokers and nonsmokers. Journal of Clinical Pharmacology 65; 508-519, 2025.

5. Dallman A, Bonate PL, Burnham J, George B, Yao L, and Knochel J. Enhancing inclusivity in clinical trials: Model-informed drug development for pregnant individuals in the era of personalized medicine. Clinical Pharmacology & Therapeutics 13; 1824-1829, 2024.

6. Zuo P, Bonate PL, Garg A, Matsangou M, and Tang M. Population pharmacokinetic modeling and exposure-response analysis for the antibody-drug conjugate Enfortumab vedotin in locally advanced or metastatic urothelial cancer. Clinical Pharmacology and Therapeutics 116; 1278-1288, 2024.

7. Tang M, Garg A, Bonate PL, Rosenberg JE, Matsangou M, Kodokura T, Yamada A, Choules M, Pavese J, Nagata M, Tenmizu D, Koibuchi A, Heo N, Wang L, Wojtkowski T, Hanley WD, Poondru S. Clinical pharmacology of the antibody drug conjugate enfortumab vedotin in advanced urothelial cancer and other malignant solid tumors. Clinical Pharmacokinetics 63; 423-438, 2024.

8. Choules MP, Bonate PL, Heo N, and Weddell J. Prospective approaches to gene therapy computational modeling – spotlight on viral gene therapy. Journal of Pharmacokinetics and Pharmacodynamics 51; 399-416, 2024.

9. Bonate PL, Barrett JS, Ait-Oudhia S, Brundage R, Corrigan B, Duffull S, Gastonguay M, Karlsson MO, Kijima S, Krause A, Riggs MM, Neely M, Ouellet D, Plan EL, Rao GG, Standing J, Wilkins J, and Zhu H. Training the next generation of pharmacometric modelers: a multisector perspective. Journal of Pharmacokinetics and Pharmacodynamics 51; 5-31, 2024. Correction: 51; 89, 2024.

10. Otsuka Y, Poondru S, Bonate PL, Rose RH, Jamei M, Ushigome F, and Minematsu T. Physiologically-based pharmacokinetic modeling to predict drug-drug interaction of enzalutamide with combined PGP and CYP3A substrates. Journal of Pharmacokinetics and Pharmacodynamics 50; 365-376, 2023.

11. Garcia A-R, Baverel P, Bottino D, Dolton M, Feng Y, Gonzalez-Garcia I, Kim J, Robey S, Singh I, Turner D, Wu S-P, Yin D, Zhou D, Zhu H, and Bonate PL. A comprehensive regulatory and industry review of modeling and simulation practices in oncology clinical drug development. Journal of Pharmacokinetics and Pharmacodynamics 50; 147-172, 2023.

12. Sahasrabudhe S and Bonate PL. Pharmacokinetic comparability between two populations using nonlinear mixed effect models: a Monte Carlo study. Journal of Pharmacokinetics and Pharmacodynamics 50; 189-201, 2023.

13. Zhang T, Cho C, and Bonate PL. Perspectives on training quantitative systems pharmacologists. CPT: Pharmacometrics & Systems Pharmacology 11; 669-672, 2022.

14. Zhang T, Androulakis IP, Bonate PL, Cheng L, Helikar T, Parikh J, Rackauckas C, Subramanian C, Cho CR. Two heads are better than one: current landscape of integrating QSP and machine learning: an ISoP QSP SIG white paper by the working group on the integration of quantitative systems pharmacology and machine learning. Journal of Pharmacokinetics and Pharmacodynamics, 49; 5-18, 2022.

15. Bonate PL. An introduction to extreme value theory for pharmacometricians. Journal of Pharmacokinetics and Pharmacodynamics 48; 83-97, 2021.

16. Otsuka Y, Choules M, Bonate PL, and Komatsu K. Physiologically-based pharmacokinetic modeling for the prediction of a drug-drug interaction of combined effects on P-glycoprotein and CYP3A. Clinical Pharmacology & Therapeutics: Pharmacometrics and Systems Pharmacology 9; 659-669, 2020.

17. Bonate PL, van Sant C, Cho K, Zook E, Smith L, Boutsaboualoy S, Ye M, Wang X, Wu R, Koester A, Rammelsberg D, Goldwater R, and Marbury T. Pharmacokinetics and immunogenicity of ASP0113 in CMV-seronegative dialysis patients and CMV-seronegative and -seropositive healthy subjects. Clinical Pharmacology in Drug Development, 9; 444-455, 2020.

18. Kovanda LL, Sullivan SM, Smith LR, Desai AV, Bonate PL, and Hope WW. Population pharmacokinetic modeling of VL-2397, a novel systemic antifungal agent: analysis of single and multiple ascending dose study in healthy volunteers. Antimicrobial Agents and Chemotherapy, 2019 May 24; 63(6).

19. Lu Z, Bonate PL, and Keirns J. Population pharmacokinetics of immediate- and prolonged release tacrolimus formulations in liver, kidney, and heart transplant recipients. British Journal of Clinical Pharmacology 85; 1693-1703, 2019.

20. Bonate PL, Wang T, Passier P, Bagchus W, Burt H, Lupfert C, Abla N, Kovac J, and Keiser J. Extrapolation of praziquantel pharmacokinetics to a pediatric population: a cautionary tale. Journal of Pharmacokinetics and Pharmacodynamics, 45; 747-762, 2018.

21. Hiroshige N, Coulibaly J, Huwyler J, Bonate PL, and Keiser J. Pharmacokinetics of a pediatric tribendimine dose-finding study to treat hookworm infection in African children. Antimicrobial Agents and Chemotherapy 18 June 2018.

22. Kovanda LL, Walsh TJ, Benjamin DK Jr., Arrieta A, Kaufman DA, Smith PB, Manzoni P, Desai AV, Kaibara A, Bonate PL, and Hope WW. Exposure-response analysis of micafungin in neonatal candidiasis: pooled analysis of two clinical trials. Pediatric Infectious Disease 37; 580-585, 2018.

23. Kummel A, Bonate PL, Dingemanse J, and Krause A. Confidence and prediction intervals for pharmacometric models. CPT Pharmacometrics and Systems Pharmacology, 1 Feb 2018. One of the top 10% of downloaded papers between Jan 2018 and Dec 2020.

24. Bonate PL. Estimation of QT interval prolongation through model averaging. Journal of Pharmacokinetics and Pharmacodynamics, 43; 335-349, 2017.

25. Garnett C, Bonate PL, Dang Q, Ferber G, Huang D, Liu J, Mehrotra D, Riley S, Sager P, Tornoe C, and Wand Y. Scientific white paper on concentration-QT modeling. Journal of Pharmacokinetics and Pharmacodynamics 45; 383-397, 2018. Correction: 45; 399, 2018.

26. Desai A, Kovanda LL, Hope WW, Andes D, Mouton JW, Kowalski DL, Townsend RW, Mujais S, and Bonate PL. Exposure-response relationships for isavuconazole in patients with invasive Aspergillosis and filamentous fungi. Antimicrobial Agents and Chemotherapy 61; e01034-17, 2017.

27. Bonate PL. Estimation of QT interval prolongation through model averaging. Journal of Pharmacokinetics and Pharmacodynamics 44; 335-349, 2017.

28. Bonate PL. Effect of correlation on covariate selection in linear and nonlinear mixed effect models. Pharmaceutical Statistics 16: 45-54, 2017.

29. Kovanda L, Desai AV, Lu Q, Townsend RW, Akhtar S, Bonate PL, Hope WW. Isavuconazole Population Pharmacokinetic Analysis Using Non-Parametric Estimation in Patients with Invasive Fungal Disease: Results from the VITAL Study. Antimicrobial Agents and Chemotherapy 60; 4568-4576, 2016.

30. Desai A, Kovanda L, Kowalski D, Lu Q, Townsend R, and Bonate PL. Population pharmacokinetics of Isavuconazole from Phase 1 and Phase 3 (SECURE) trials in adults and target attainment in patients with infections due to aspergillus and other filamentous fungi. Antimicrobial Agents and Chemotherapy 22: 5483-5491, 2016.

31. Bonate PL, Ahamadi M, Budha N, de la Pena A, Earp JC, Hong Y, Karlsson MO, Ravva P, Ruiz-Garcia A, Strumper H, and Wade J. Methods and strategies for assessing uncontrolled drug–drug interactions in population pharmacokinetic analyses: results from the International Society of Pharmacometrics (ISOP) Working Group. Journal of Pharmacokinetics and Pharmacodynamics 43: 123-135, 2016.

32. Bonate PL. Simulation studies on the estimation of total area under the curve in the presence of right-tailed censoring. Journal of Pharmacokinetics and Pharmacodynamics 42: 19-32, 2015.

33. Bonate PL. What happened to the modeling and simulation revolution? Clinical Pharmacology & Therapeutics 96: 416-417, 2014.

34. Bonate PL and Suttle B. Modeling tumor growth kinetics after treatment with pazopanib or placebo in patients with renal cell carcinoma. Cancer Chemotherapy Pharmacology 72: 231-240, 2013.

35. Bonate PL and Suttle B. Effect of censoring due to disease progression on tumor size kinetic parameters. AAPS Journal, 15: 832-839, 2013.

36. Bonate PL. Effect of assay measurement error on parameter estimates in concentration-QTc modeling. Pharmaceutical Statistics, 12: 156-164, 2013.

37. Shah M, Wainberg ZA, Catenacci DVT, Hochster H,Ford J, Kunz P, Lee F-C, Kallender H, Checchi F, Rabe DC, Keer H, Martin A-M, Liu Y, Gagnon R, Bonate P, Liu T, and Bottaro DP. Phase II study evaluating 2 dosing schedules of oral foretinib (GSK1363089), cMET/VEGFR2 inhibitor, in patients with metastatic gastric cancer. PLOS One 8(3), e54015, 2013.

38. Bonate PL. The effect of active metabolites on parameter estimation in linear mixed effects models of concentration-QT analyses. Journal of Pharmacokinetics and Pharmacodynamics 40: 101-115, 2013.

39. Bonate PL, Strougo A, Desai A, Roy M, Yassen A, van der Walt JS, Kaibara A, and Tannenbaum S. Guidelines for the quality control of population pharmacokinetic-pharmacodynamic analyses: an industrial perspective. The AAPS Journal, July 2012.

40. Naing A, Kurzrock R, Adams LM, Kleha JF, Laubscher KH, Bonate PL, Weller S, Fitzgerald C, Xu Y, Lorusso PM. A comparison of the pharmacokinetics of the anticancer MET inhibitor foretinib free base tablet formulation to bisphosphate salt capsule formulation in patients with solid tumors. Investigational New Drugs 51: 695-705, 2012.

41. Bonate PL. Pharmacokinetics. Wiley Interdisciplinary Reviews: Computational Statistics 3; 332-342, 2011.

42. Peterschmitt MJ, Burke A, Blankstein L, Smith S, Puga A, Kramer W, Harris J, Mathews D, and Bonate PL. Safety, tolerability, and pharmacokinetics of Genz-112638 after single doses, multiple doses, and food in healthy volunteers. Journal of Clinical Pharmacology 51; 695-705, 2011.

43. Bonate PL, Cunningham CC, Gaynon P, Jeha S, Kadota R, Lam GL, Razzouk B, Rytting M, Steinherz P, and Weitman S. Population pharmacokinetics of clofarabine and its metabolite 6-ketoclofarabine in adult and pediatric patients with cancer. Cancer Chemotherapy and Pharmacology 67; 875-890, 2011.

44. Lukina E, Watman N, Arreguin EA, Banikazemi M, Dragosky M, Iastrebner M, Rosenbaum H, Phillips M, Pastores GM, Rosenthal DI, Kaper M, Singh T, Puga AC, Bonate PL, and Peterschmitt MJ. A Phase 2 study of eliglustat tartrate (Genz-112638), an oral substrate reduction therapy for Gaucher disease type 1. Blood 116; 893-899, 2010.

45. Ajavon AD, Bonate PL, and Taft DR. Renal excretion of clofarabine: assessment of dose-linearity and the role of renal transport systems on drug excretion. European Journal of Pharmaceutical Sciences 40; 209-216, 2010.

46. Bonate PL, Sung C, Welch K, and Richards S. Conditional modeling of antibody titers using a zero-inflated Poisson random effects model: application to Fabrazyme®. Journal of Pharmacokinetics and Pharmacodynamics 36; 443-460, 2009.

47. Kilburn LB, Bonate PL, Blaney SM, McGuffey L, Nuchtern JG, Dauser R, Thompson P, Gibson BW, and Berg SL. Plasma and cerebrospinal fluid pharmacokinetics of tasidotin (ILX-651) and its metabolites in non-human primates. Cancer Chemotherapy and Pharmacology 64; 335-340, 2009.

48. Bai R, Edler MC, Bonate PL, Copeland TD, Pettit GR, Luduena R, and Hamel E. Intracellular activation and deactivation of tasidotin, an analogue of dolastatin 15: correlation with cytotoxicity. Molecular Pharmacology 75; 218-226, 2009.

49. Bonate PL, Beyerlein D, Crawford J, Roth S, Krumholz R, and Schmid S. Pharmacokinetics in mice implanted with xenografted tumors after intravenous administration of tasidotin (ILX651) or its carboxylate metabolite. AAPS Journal, 9; E378-E387, 2007.

50. Mould DR, Baumann A, Kuhlmann J, Keating MJ, Weitman S, Hillmen P, Brettman LR, Reif S, and Bonate PL. Population pharmacokinetics of alemtuzumab (Campath®) in patients with chronic lymphocytic leukemia and its link to treatment response. British Journal of Clinical Pharmacology, 64; 278-291, 2007.

51. Bonate PL, Arthaud L, Cantrell WJ, JR., Stephenson K, Secrist JA III, Weitman S. Discovery and development of clofarabine, a nucleoside analogue for treating cancer. Nature Reviews Drug Discovery 5; 855-863, 2006.

52. Mita AC, Hammond LA, Bonate PL, Weiss G, McCreery H, Syed S, Garrison M, Chu QSC, DeBono JS, Jones CB, Weitman S, Rowinsky E. Phase I and pharmacokinetic study of tasidotin hydrochloride (ILX651), a third-generation dolastatin-15 analogue, administered weekly for three weeks every 28 days in patients with advanced solid tumors. Clinical Cancer Research 12; 5207-5215, 2006.

53. Gandhi V, Plunkett W, Bonate PL, Du M, Nowak B, Lerner S, and Keating S. Clinical and pharmacokinetic study of clofarabine in chronic lymphocytic leukemia: strategy for treatment. Clinical Cancer Research 12, 4011-4017, 2006.

54. Bonate PL. Recommended reading in population pharmacokinetics. AAPS Journal 7, E363-E373, 2005.

55. Ebbinhaus S, Rubin E, Hersch E, Cranmer LD, Bonate PL, Fram RJ, Jejuken A, Weitman S, Hammond LA. A Phase I Study of the Dolastatin-15 Analogue Tasidotin (ILX651) Administered Intravenously Daily for 5 Consecutive Days Every 3 Weeks in Patients with Advanced Solid Tumors. Clinical Cancer Research 11, 7807-7816, 2005.

56. Cunningham C, Appleman LJ, Kirvan-Visovatti M, Ryan DP, Regan E, Vukelja S, Bonate PL, Ruvuna F, Fram RJ, Jekunen A, Weitman S, Hammond LA, Eder JP Jr. Phase I and Pharmacokinetic Study of the Dolastatin-15 Analogue Tasidotin (ILX651) Administered Intravenously on Days 1, 3, and 5 Every 3 Weeks in Patients with Advanced Solid Tumors. Clinical Cancer Research 11, 7825-7833, 2005.

57. Berg S, Bonate PL, Nuchtern JG, Dauser R, McGuffey L, Bernacky B, and Blaney SM. Plasma and cerebrospinal fluid pharmacokinetics of clofarabine in nonhuman primates. Clinical Cancer Research 11, 5981-5983, 2005.

58. Bonate PL, Arthaud L, Stuhler J, Yerino P, Press RJ, and Rose JQ. The distribution, metabolism, and elimination of clofarabine in rats. Drug Metabolism and Disposition, 33, 739-749, 2005.

59. Bonate PL. Covariate detection in population pharmacokinetics using partially linear mixed effects models. Pharmaceutical Research, 22, 541-549, 2005.

60. Bonate PL, Craig A, Gaynon P, Gandhi V, Jeha S, Kadota R, Lam GN, Plunkett W, Razzouk B, Rytting M, Steinherz P, and Weitman S. Population pharmacokinetics of clofarabine, a second-generation nucleoside analog, in pediatric patients with acute leukemia. Journal of Clinical Pharmacology 44, 1309-1322, 2004.

61. Faderl S, Gandhi V, O'Brien S, Bonate P, Cortes J, Estey E, Beran M, Wierda W, Garcia-Manero G, Ferrajoli A, Estrov Z, Giles FJ, Du M, Kwari M, Keating M, Plunkett W, and Kantarjian H. Results of a phase I-II study of clofarabine in combination with cytarabine (Ara-C) in relapsed and refractory acute leukemias. Blood 105; 940-947; 2005.

62. Bonate PL, Floret S, and Bentzen C: Population pharmacokinetics of apomine: a meta-analysis in healthy males and cancer patients. British Journal of Clinical Pharmacology 58; 142-155, 2004.

63. Aquino VM, Weitman SD, Winick NJ, Blaney S, Furman WL, Kepner JL, Bonate PL, Krailo M, Qu W, and Bernstein M. Phase I trial of tirapazamine and cyclophosphamide in children with refractory solid tumors: a pediatric oncology group study. Journal of Clinical Oncology 22; 1413-1419, 2004.

64. Gandhi V, Kantarjian H, Faderl S, Bonate PL, Du M, Ayres M, Rios MB, Keating MJ, and Plunkett W: Pharmacokinetics and pharmacodynamics of plasma clofarabine and cellular clofarabine triphosphate in patients with acute leukemias. Clinical Cancer Research 9, 6335-6342, 2003.

65. Wieder R, Novick SC, Hollis B, Bryan M, Chanel S, Owusu K, Camastra D, Saunders T, Pliner L, Harrison J, Bonate PL, Williams T, and Soignet S: Pharmacokinetics and safety of ILX23-7553, a noncalcemic-vitamin D3 analogue, in a phase I study of patients with advanced malignancies. Investigational New Drugs 21, 435-443, 2003.

66. Agrawal AM, Neau SH, and Bonate PL: Wet granulation fine particle ethylcellulose tablets: effect of production variables and mathematical modeling of drug release. AAPS PharmSci 5(2), Article 13, 2003.

67. Bonate PL: A brief introduction to Monte Carlo simulation. Clinical Pharmacokinetics 40, 15-22, 2001.

68. Bonate PL: Clinical trial simulation in drug development. Pharmaceutical Research 17, 252-256, 2000.

69. Bonate PL: Rank power of metrics used to assess QTc interval prolongation by clinical trial simulation. The Journal of Clinical Pharmacology 40, 468-474, 2000.

70. Bonate PL and D. Howard: Prospective allometric scaling: Does the emperor have clothes? and Rejoinder. Journal of Clinical Pharmacology 40, 335-340 and 345-346, 2000.

71. Holford NHG, Hale M, Ko HC, Steimer J-L, Sheiner LB, and Peck CC. Contributors: Bonate PL, Gillespie WR, Ludden T, Rubin DB, Stanski D. Simulation in Drug Development: Best Practices. Center for Drug Development Science, Georgetown University, 2000.

72. Bonate PL: The effect of collinearity on nonlinear mixed effect models. Pharmaceutical Research 16, 709-717, 1999.

73. Bonate PL, Kroboth PD, Smith RB, Suarez E, and Oo C: Clonazepam and sertraline: absence of drug interaction in a multiple dose study. Journal of Clinical Psychopharmacology 20, 19-27, 2000.

74. Bonate PL and Russell T: Assessment of QTc prolongation for non-cardiac drugs from a drug development perspective. Journal of Clinical Pharmacology 39, 349-358, 1999.

75. Bonate PL, Reith K, and Weir S: Drug interactions at the renal level: implications for drug development. Clinical Pharmacokinetics 34, 375-404, 1998.

76. Bonate PL: Coverage and precision of parametric and non-parametric confidence intervals for area under the curve in a toxicokinetic experimental design. Pharmaceutical Research 15, 405-410, 1998.

77. Bonate PL: Interspecies scaling of the pharmacokinetic parameters of cocaine and application to the pharmacokinetics in man. Pharmaceutical Sciences 3, 507-511, 1997.

78. Bonate PL, Swann A, and Silverman PB: Behavioral sensitization to cocaine in the absence of altered brain cocaine levels. Pharmacology Biochemistry and Behavior 57, 665-669, 1997.

79. Bonate PL, Swann A, and Silverman PB: Context-dependent cross-sensitization between cocaine and amphetamine. Life Sciences 60, PL1-7, 1996.

80. Bonate PL, Swann A, and Silverman PB: A preliminary physiological based pharmacokinetic model for cocaine in the rat: model development and scale-up to humans. Journal of Pharmaceutical Sciences 85, 878-883, 1996.

81. Bonate PL, Davis CM, Silverman PB, and Swann A: Analysis of cocaine in biological matrices: application to plasma and brain tissue. Journal of Liquid Chromatography 18, 3473-3494, 1995.

82. Kasper SC, Bonate PL, and DeLong AF: High performance liquid chromatographic assay for xanomeline, a specific M-1 agonist, and metabolite in human plasma. Journal of Chromatography B 669, 397-403, 1995.

83. Templin MV, Stevens DK, Stenner RD, Bonate PL, Tuman D, and Bull RJ: Factors affecting species differences in the kinetics of metabolites of trichloroethylene. Journal of Toxicology and Environmental Health 44, 435-447, 1995.

84. Bonate PL and Peyton A: Studies on the uptake and biodisposition of LY217896 by red blood cells. Biopharmaceutics and Drug Disposition 16, 151-167, 1995.

85. Bonate PL: Animal models for studying transport across the blood-brain barrier. Journal of Neuroscience Methods 56, 1-15, 1995.

86. Murphy AT, Bonate PL, Kasper SC, Gillespie TA, and DeLong AF: Determination of xanomeline in human plasma by ion-spray tandem mass spectrometry. Biological Mass Spectrometry 23, 621-625, 1994.

87. Bonate PL: Approximate confidence intervals in calibration using the bootstrap. Analytical Chemistry 65, 1367-1372, 1993.

88. Bonate PL: Gender-related differences in drug metabolism. Journal of Clinical Pharmacology 31, 684-690, 1991.

89. Bonate PL: Serotonin receptor subtypes: physiological, functional, and clinical correlates. Clinical Neuropharmacology 14, 1-16, 1991.

90. Bonate PL: Chromatographic calibration revisited. Journal of Chromatographic Science 28, 559-562, 1990.

91. Bonate PL: Pathophysiology and pharmacokinetics following burn injury. Clinical Pharmacokinetics 18, 117-129, 1990.

92. Bonate PL: Quantification of albumin in cerebrospinal fluid. Analytical Biochemistry 175, 300-304, 1988.

Book Chapters

1. Bonate PL and Silverman PB: The role of conditioned stimuli in drug addiction. In: Drug Addiction and Its Treatment: Nexus of Neuroscience and Behavior (Eds: Johnson BA and Roache J). Raven Press, New York, 1997.

2. DeLong AF, Bonate PL, Gillespie T, Henry DP, Satterwhite JH: Absorption, distribution, metabolism, and elimination of radiolabeled xanomeline in healthy male subjects. In: Alzheimer's Disease: Recent Developments, Third International Conference (Ed: Hanin I, Yoshida M, and Fisher A), 1994.

3. Bonate PL: Assessment of QTc interval prolongation in a Phase 1 study using Monte Carlo simulation. In: Simulation for Designing Clinical Trials: A Pharmacokinetic-Pharmacodynamic Modeling Perspective (Ed: Kimko H and Duffull S). Marcel Dekker, New York, 2003, pp. 353-366.

4. Vicini P and Bonate PL. Preclinical pharmacokinetic-pharmacodynamic modeling and simulation in drug development. In: Preclinical Drug Development (Ed: Taft D and Rogge M). Marcel Dekker, New York, 2005, pp. 199-220.

5. Bonate PL, Arthaud L, and Stephenson K. Preclinical and clinical drug development of tasidotin, a depsi-pentapeptide oncolytic. Pharmacokinetics and Pharmacodynamic of Biotech Drugs: Principles and Case Studies in Drug Development (Ed: Meibohm B), John Wiley and Sons, New York, 2007, pp. 331-351.

6. Bonate PL. Clinical trial simulation: theory. Pharmacometrics: The Science of Quantitative Pharmacology (Ed: Ette E). John Wiley and Sons, New York, 2007, pp. 851-871.

7. Bonate PL and Vicini P. Preclinical pharmacokinetic-pharmacodynamic modeling and simulation in drug development (updated). In: Preclinical Drug Development (Ed: Taft D and Rogge M), second edition. Informa Healthcare USA, New York, 2010, pp. 142-160.

8. Bonate PL. Covariate distribution models in simulation. Clinical Trial Simulations: Applications and Trends (Eds: Kimko H and Peck C). Springer, New York, 2011.

9. Bonate PL, Desai A, Rizwan A, Lu Z, and Tannenbaum S. Nonlinear mixed effects models in systems pharmacology. Systems Pharmacology and Pharmacodynamics. Springer, New York, 2016.

10. Bonate PL. Controversies in oncology: size-based vs. fixed dosing. Pharmacokinetics in Drug Development, Vol. 4: Problems and Challenges in Oncology. Springer, New York, 2016.

11. Bonate PL and ECM de Lange. Modeling and simulation in the translational pharmacology of CNS drugs. In: Translational Medicine in CNS Drug Development (Eds: Nomikos GG and Feltner DE). Handbook of Behavioral Neuroscience, Vol. 29, pp. 25-37, 2019.

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