GastroPlus在FDA、EMA等法規部門的應用文章列表（2016-2020）

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

12.   采用眼部機制性吸收建模與模擬，理解制劑處方性質對家兔眼部生物利用度的影響-以地塞米松懸浮液為例

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.   采用計算機預測的方法開發仿制藥-裝置組合的口服吸入制劑

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.   建立體外-體內相關的溶出和轉化建模策略-某研討會總結匯總

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, Sj?gren 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.   具有體內預測性的溶出方法和模擬研討會匯總：促進口服藥物制劑處方的開發和口服療效的預測

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.   膜轉運蛋白體外-計算機預測數據在化學品風險評估和生物醫學研究中的適用性

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.   開發機制性吸收模型，以預測因溶酶體捕獲而導致Tmax較長的速釋弱堿性藥物的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.   滲透泵藥品的生理藥代動力學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.   生理藥代動力學PBPK模型在食物對口服藥物吸收影響的預測性能：現狀

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.   生理藥代動力學PBPK模型對代謝酶介導的藥物相互作用DDI的預測性能

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.   采用生理藥代動力學吸收模型預測質子泵抑制劑存在時，鹽型-游離堿轉化對普拉格雷HCl藥品生物等效性的影響

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.   通過整合體外、建模、體內三種方法探討華法林的生物等效性

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.   探索藥品研發中狗和人的差異性II：采用建模與模擬的方法探索制劑因素對環丙沙星狗體內吸收與溶出的影響

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.   通過生理藥代動力學PBPK模型對藥物納米顆粒進行建模

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研討會上關于生理藥代動力學PBPK建模和模擬的資質和結果報告的匯總

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.  提高藥品質量：美國FDA藥品質量辦公室的科學和研究概述

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.   采用機制性吸收模型研究哌甲酯口服緩釋制劑在成人體內的藥動學曲線

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.   采用建模與模擬探究處方對低溶解度藥物吸收的影響-環丙沙星

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.   開發和驗證雌二醇經皮給藥系統的體內外相關性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.   生理學吸收模型在安非他命鹽型藥品的仿制藥評價中的應用

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.   利培酮微球注射劑的體內外相關性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.   通過建模與模擬研究質子泵抑制劑PPI對鎂離子吸收的影響

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

33.   使用體內外相關性IVIVC預測幾種BCS 1類藥物緩釋骨架片的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.   具有預測性的生物藥劑學建模和模擬方法在藥物開發和法規監管評估中的作用

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.   藥物開發階段，采用基于生理學的吸收模型實施質量源于設計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.   生理藥代動力學PBPK建模與模擬在法規監管審評中的應用

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.  整合生命階段的生理藥代動力學PBPK模型與不良結果通路（AOPs）和環境暴露模型，以篩選對環境的危害

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.   使用高通量的體外數據，高通量暴露模型，生理藥代動力學/藥效模型，估算甲狀腺過氧化物酶抑制劑的體內暴露

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