GastroPlus在FDA、EMA等法规部门的应用文章列表（2016-2020）

Hens B, Corsetti M, Bermejo M, Löbenberg R, González PM, Mitra A, Desai D, Chilukuri DM, Aceituno A. AAPS J. Jun 6, 2019. IF= 3.737

12.   采用眼部机制性吸收建模与模拟，理解制剂处方性质对家兔眼部生物利用度的影响-以地塞米松悬浮液为例

Application of Mechanistic Ocular Absorption Modeling and Simulation to Understand the Impact of Formulation Properties on Ophthalmic Bioavailability in Rabbits: a Case Study Using Dexamethasone Suspension.

Le Merdy M, Fan J, Bolger MB, Lukacova V, Spires J, Tsakalozou E, Patel V, Xu L, Stewart S, Chockalingam A, Narayanasamy S, Rouse R, Matta M, Babiskin AH, Kozak D. AAPS J. May 20, 2019. IF=3.737

13.   采用计算机预测的方法开发仿制药-装置组合的口服吸入制剂

In silico methods for development of generic drug‐device combination orally inhaled drug products.

Walenga RL, Babiskin AH, Zhao L. CPT Pharmacometrics Syst Pharmacol.May 1, 2019. CiteScore=5.2

14.   建立体外-体内相关的溶出和转化建模策略-某研讨会总结汇总

Dissolution and Translational Modeling Strategies Toward Establishing an In Vitro-In Vivo Link-a Workshop Summary Report.

Heimbach T, Suarez-Sharp S, Kakhi M, Holmstock N, Olivares-Morales A, Pepin X, Sjögren E, Tsakalozou E, Seo P, Li M, Zhang X, Lin HP, Mitra A, Morris D, Patel N, Kesisoglou F. AAPS J. Feb 11, 2019. IF=3.737

15.   具有体内预测性的溶出方法和模拟研讨会汇总：促进口服药物制剂处方的开发和口服疗效的预测

In Vivo Predictive Dissolution and Simulation Workshop Report: Facilitating the Development of Oral Drug Formulation and the Prediction of Oral Bioperformance.

Tsume Y, Patel S, Fotaki N, Bergstrom CAS, Amidon GL, Brasseur JG, Mudie DM, Sun D, Bermejo M, Gao P, Zhu W, Sperry DC, Vertzoni M, Parrott N, Lionberger RA, Kambayashi A, Hermans A, Lu X, Amidon GE.AAPS J. 2018 Sep 6;20(6):100. IF=3.737

16.   膜转运蛋白体外-计算机预测数据在化学品风险评估和生物医学研究中的适用性

Capturing the applicability of in vitro-in silico membrane transporter data in chemical risk assessment and biomedical research.

Clerbaux LA, Coecke S, Lumen A, Kliment T, Worth AP, Paini A. Sci Total Environ. 2018 Dec 15;645:97-108. IF=6.551

17.   开发机制性吸收模型，以预测因溶酶体捕获而导致Tmax较长的速释弱碱性药物的PK

Developing a mechanistic absorption model to predict the pharmacokinetics of immediaterelease weak base drugs with a long Tmax by incorporating lysosomal trapping.

Jia Li, Zhongqi Dong, Fang Wu, Ping Zhao, Sue Chih Lee, Paul Seo, Lei Zhang. Drug Metabolism and Pharmacokinetics 33 (2018) S22-S97.IF=2.772

18.   渗透泵药品的生理药代动力学PBPK和吸收模型

Physiologically Based Pharmacokinetic and Absorption Modeling for Osmotic Pump Products.

Ni Z, Talattof A, Fan J, Tsakalozou E, Sharan S, Sun D, Wen H, Zhao L, Zhang X. AAPS J. 2017 Jul;19(4):1045-1053. IF=3.737

19.   生理药代动力学PBPK模型在食物对口服药物吸收影响的预测性能：现状

Predictive Performance of Physiologically Based Pharmacokinetic Models for the Effect of Food on Oral Drug Absorption: Current Status.

Li M, Zhao P, Pan Y, Wagner C. CPT Pharmacometrics Syst Pharmacol.2018 Feb;7(2):82-89. CiteScore=5.2

20.   生理药代动力学PBPK模型对代谢酶介导的药物相互作用DDI的预测性能

Predictive Performance of Physiologically-Based Pharmacokinetic Models in Predicting Drug-Drug Interactions Involving Enzyme Modulation.

Hsueh CH, Hsu V, Pan Y, Zhao P. Clin Pharmacokinet. 2018 Feb 17.IF=4.604

21.   采用生理药代动力学吸收模型预测质子泵抑制剂存在时，盐型-游离碱转化对普拉格雷HCl药品生物等效性的影响

Utility of Physiologically Based Pharmacokinetic Absorption Modeling to Predict the Impact of Salt-to-Base Conversion on Prasugrel HCl Product Bioequivalence in the Presence of Proton Pump Inhibitors.

Fan J, Zhang X, Zhao L. AAPS J. 2017: 1-8. IF=3.737

22.   通过整合体外、建模、体内三种方法探讨华法林的生物等效性

Integrating in vitro, modeling, and in vivo approaches to investigate warfarin bioequivalence.

Zhang X, Wen H, Fan J, et al. CPT: Pharmacometrics & Systems Pharmacology, 2017. CiteScore=5.2

23.   探索药品研发中狗和人的差异性II：采用建模与模拟的方法探索制剂因素对环丙沙星狗体内吸收与溶出的影响

Exploring Canine-Human Differences in Product Performance. Part II: Use of Modeling and Simulation to Explore the Impact of Formulation on Ciprofloxacin In Vivo Absorption and Dissolution in Dogs.

Martinez M N, Mistry B, Lukacova V, et al. AAPS J, 2017, 19(3): 712-726.IF=3.737

24.   通过生理药代动力学PBPK模型对药物纳米颗粒进行建模

Physiologically based pharmacokinetic (PBPK) modeling of pharmaceutical nanoparticles.

Li M, Zou P, Tyner K, et al. AAPS J, 2017: 1-17. IF=3.737

25.  在EMA研讨会上关于生理药代动力学PBPK建模和模拟的资质和结果报告的汇总

Report from the EMA workshop on qualification and reporting of physiologically based pharmacokinetic (PBPK) modeling and simulation.

Zhao P. CPT: pharmacometrics & systems pharmacology, 2017, 6(2): 71-72. CiteScore=5.2

26.  提高药品质量：美国FDA药品质量办公室的科学和研究概述

Advancing pharmaceutical quality: An overview of science and research in the US FDA’s Office of Pharmaceutical Quality.

Fisher A C, Lee S L, Harris D P, et al. International journal of pharmaceutics, 2016, 515(1): 390-402. IF= 4.845

27.   采用机制性吸收模型研究哌甲酯口服缓释制剂在成人体内的药动学曲线

Application of Physiologically Based Absorption Modeling to Characterize the Pharmacokinetic Profiles of Oral Extended Release Methylphenidate Products in Adults.

Yang X, Duan J, Fisher.J. PloS one, 2016, 11(10): e0164641. IF=2.74

28.   采用建模与模拟探究处方对低溶解度药物吸收的影响-环丙沙星

Use of Modeling and Simulation Tools for Understanding the Impact of Formulation on the Absorption of Low Solubility Compound: Ciprofloxacin.

Martinez M, Mistry B, Lukacova V, Polli J, Hoag S, Dowling T, Kona R, Fahmy R. AAPS J. Apr 26. IF=3.737

29.   开发和验证雌二醇经皮给药系统的体内外相关性IVIVC模型

Development and validation of in vitro-in vivo correlation (IVIVC) for estradiol transdermal drug delivery systems.

J Control Release. May 13;210:58-66. IF=7.727

30.   生理学吸收模型在安非他命盐型药品的仿制药评价中的应用

Application of Physiologically Based Absorption Modeling for Amphetamine Salts Drug Products in Generic Drug Evaluation.

Babiskin AH, Zhang X. (2015). J Pharm Sci. May 13. IF=2.997

31.   利培酮微球注射剂的体内外相关性IVIVC模型

In vitro-in vivo correlation of parenteral risperidone polymeric microspheres.

Shen J, Choi S, Qu W, Wang Y, Burgess DJ. (2015) J Control Release. Sep 28;218:2-12. IF=7.727

32.   通过建模与模拟研究质子泵抑制剂PPI对镁离子吸收的影响

Bai JP, Hausman E, Lionberger R, Zhang X. (2012) Mol. Pharmaceutics 2012, 9, 12, 3495–3505. IF=4.321

33.   使用体内外相关性IVIVC预测几种BCS 1类药物缓释骨架片的PK

Use of In Vitro-In Vivo Correlation to Predict the Pharmacokinetics of Several Products Containing a BCS Class 1 Drug in Extended Release Matrices.

Mirza T, Bykadi SA, Ellison CD, Yang Y, Davit BM, Khan MA. (2012)Pharm. Res. Aug. 22. IF=3.242

34.   具有预测性的生物药剂学建模和模拟方法在药物开发和法规监管评估中的作用

The role of predictive biopharmaceutical modeling and simulation in drug development and regulatory evaluation.

Jiang W, Kim S, Zhang X, Lionberger RA, Davit BM, Conner DP, Yu LX. (2011) Int J Pharm. 418(2):151-60. IF=4.845

35.   药物开发阶段，采用基于生理学的吸收模型实施质量源于设计QbD

Utility of Physiologically Based Absorption Modeling in Implementing Quality by Design in Drug Development.

Zhang X, Lionberger RA, Davit BM, Yu LX. (2011) AAPS J. 13(1):59-71.IF=3.737

36.   生理药代动力学PBPK建模与模拟在法规监管审评中的应用

Applications of Physiologically Based Pharmacokinetic (PBPK) Modeling and Simulation During Regulatory Review.

Zhao P, Zhang L, Grillo JA, Liu Q, Bullock JM, et al. (2011)Clin Pharmacol Ther. 89(2):259-67. IF=6.565

37.  整合生命阶段的生理药代动力学PBPK模型与不良结果通路（AOPs）和环境暴露模型，以筛选对环境的危害

Integration of Life-Stage Physiologically-Based Pharmacokinetic (PBPK) Models with Adverse Outcome Pathways (AOPs) and Environmental Exposure Models to Screen for Environmental Hazards.

El-Masri H, Kleinstreuer N, Hines RN, Adams L, Tal T, Isaacs K, Wetmore BA, Tan YM. (2016). Toxicol Sci. May 4. IF=3.703

38.   使用高通量的体外数据，高通量暴露模型，生理药代动力学/药效模型，估算甲状腺过氧化物酶抑制剂的体内暴露

Estimating Margin of Exposure to Thyroid Peroxidase Inhibitors Using High-throughput In Vitro Data, High-throughput Exposure Modeling, and Physiologically-Based Pharmacokinetic / Pharmacodynamic Modeling.