GastroPlus 在PBPK、ACAT、PBBM 模型應用的綜述文章（2011-2020）
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凡默谷技術部精取了2011-2020年10月GastroPlus在PBPK、ACAT、PBBM模型應用的綜述文章55篇。
其中序號1-20的文章是2019年8月-2020年10月新增文章。
希望對您的業務或專業學習有所幫助。內容如下：
Riedmaier AE, DeMent K, Huckle J, Bransford P, Stillhart C, Lloyd R, Alluri R, Basu S, Chen Y, Dhamankar V, Dodd S, Kulkarni P, Olivares-Morales A, Peng CC, Pepin X, Ren X, Tran T, Tistaert C, Heimbach T, Kesisoglou F, Wagner C, Parrott N. AAPS J. Article number: 123(2020). IF= 3.737
2.具有生物預測性的體外方法：研討會總結報告
Pepin XJ, Dressman J, Parrott N, Delvadia P, Mitra A, Zhang X, Kolhatkar V, Seo P, Taylor LS, Sj?gren E, Butler JM, Kostewicz ES, Tannergren C, Koziolek M, Kesisoglou F, Dallmann A, Zhao Y, Suarez-Sharp S. J Pharm Sci. September 2020.IF= 2.997
3. 使用基于生理的生物藥劑學模型（PBBM）預測速釋制劑空腹和餐后的生物等效性
4. 藥物開發過程中，當前食物效應預測方法的綜述
A Review of Current Methods for Food Effect Prediction During Drug Development
5. 生理藥代動力學PBPK 模型在兒科領域：開始走向成熟？
Physiologically-based pharmacokinetic models for children: Starting to reach maturation?
6. 食物對藥物口服吸收的影響：生理藥代動力學PBPK 模型作為預測工具的應用
Food Effects on Oral Drug Absorption: Application of Physiologically-Based Pharmacokinetic Modeling as a Predictive Tool.
7. 通過體外溶出曲線相似性支持藥品的質量評估：內容，如何應用，何時應用—研討會總結報告
In Vitro Dissolution Profiles Similarity Assessment in Support of Drug Product Quality: What, How, When—Workshop Summary Report.
8．結構和PK 功能的類似物在開發和評估生理藥代動力學PBPK 模型中的應用
Application of structural and functional pharmacokinetic analogs for physiologically based pharmacokinetic model development and evaluation.
9． 用于支持藥品開發，生產變更與控制的轉化建模策略的現狀和未來期望：研討會總結報告
Current State and Future Expectations of Translational Modeling Strategies to Support Drug Product Development, Manufacturing Changes and Controls: A Workshop Summary Report.
10．提高人體內PK 預測的準確性：從阿斯利康20 年藥物研發管線里學到的經驗
Improving the Accuracy of Predicted Human Pharmacokinetics: Lessons Learned from theAstraZeneca Drug Pipeline Over Two Decades.
11．針對口服給藥的建模轉化策略：學術，工業和監管的觀點
Translational Modeling Strategies for Orally Administered Drug Products: Academic,Industrial and Regulatory Perspectives
Sandra Suarez-Sharp, Anders Lindahl, Tycho Heimbach, Amin Rostami-Hodjegan, Michael B. Bolger, Siladitya Ray Chaudhuri, Bart Hens. Pharm Res. 2020 May 13;37(6):95. IF=3.242
12．體內外相關性IVIVC在藥物口服制劑開發中的應用：最近二十年縮影
Marcelo Gomes Davan?o, Daniel Rossi Campos, Patrícia de Oliveira Carvalho.International Journal of Pharmaceutics. Volume 580, 30 April 2020, 119210.IF=4.845
13．采用生理藥代動力學模型，考察腸道CYP3A 弱調節劑對藥物相互作用風險的關鍵影響
Yamada M, Inoue SI, Sugiyama D, Nishiya Y, Ishizuka T, Watanabe A, Watanabe K, Yamashita S, Watanabe N. Drug Metab Dispos. 48:288–296, April 2020. IF=3.231
14．用于首次人體臨床研究的固體制劑的工業開發方法：預測科學和精益原理的應用
An industrial approach towards solid dosage development for first-in-human studies: Application of predictive science and lean principles.
Kalaria DR, Parker K, Reynolds GK, Laru J. Drug Discovery Today. Volume 25, Issue 3, March 2020, Pages 505-518. IF=7.321
15．開發具有臨床相關性的口服藥品溶出標準-制藥企業和法規監管的觀點
Developing Clinically Relevant Dissolution Specifications for Oral Drug Products-Industrial and Regulatory Perspectives.
McAllister M, Flanagan T, Boon K, Pepin X, Tistaert C, Jamei M, Abend A, Kotzagiorgis E, Mackie CE. Pharmaceutics. 2019 Dec 23;12(1):19. IF=4.421
16．用結構多樣且溶解度低的藥物評估口服吸收模擬軟件的預測特征
Prediction characteristics of oral absorption simulation software evaluated using structurallydiverse low solubility drugs.
T, Sugano K. J Pharm Sci. Volume 109, Issue 3, March 2020, Pages 1403-1416.IF=2.997
17．使用基于生理的生物藥劑學PBBM 模型預測具有pH 依賴的堿性藥物的藥物相互作用DDI
Prediction of pH-Dependent Drug-Drug Interactions for Basic Drugs Using Physiologically Based Biopharmaceutics Modeling: Industry Case Studies.
Mitra A, Parrott N, Miller N, Lloyd R, Tistaert C, Heimbach T, Ji Y, Kesisoglou F. J Pharm Sci. Volume 109, Issue 3, March 2020, Pages 1380-1394. IF=2.997
18．考察無定型納米顆粒對難溶性藥物口服吸收影響的建模實用方法
Practical approach to modeling the impact of amorphous drug nanoparticles on the oral absorption of poorly soluble drugs.
Stewart AM, Grass M. Mol. Pharmaceutics. 2020, 17, 180?189. IF=4.321
19．采用具有生物預測性的體外測試方法，評估過飽和劑型在腸道中的吸收
Biopredictive in vitro testing methods to assess intestinal drug absorption from supersaturating dosage forms.
Hens B, Kataoka M, Ueda K, Gao P, Tsume Y, Augustijns P, Kawakami K, Yamashita S. J Drug Deliv Sci Technol. Volume 56, Part B, April 2020, 101275. IF=2.734
20．食品成分的安全性評估：毒性動力學方法的實用性和相關性
Food ingredient safety evaluation: Utility and relevance of toxicokinetic methods.
Volume 382, 1 November 2019, 114759. IF=3.347
21. 使用藥物代謝酶和轉運體的蛋白豐度數據庫，進行生理藥代動力學PBPK 的建模和模擬
A repository of protein abundance data of drug metabolizing enzymes and transporters for applications in physiologically based pharmacokinetic (PBPK) modelling and simulation.
Ladumor MK, Thakur A, Sharma SS, Rachapally A, Mishra S, Bobe P, Rao VK, Pammi P, Levi D, Balhara A, Ghandikota S, Joshi A, Nautiyal V, Prasad B, Singh S.Scientific Reports. 2019 July. IF=3.998
22. 建立可信度高的生理藥代動力學PBPK 模型的要求及克服相應的一些挑戰
Requirements to Establishing Confidence in Physiologically Based Pharmacokinetic (PBPK) Models and Overcoming Some of the Challenges to Meeting Them.
Peters SA, Dolgos H. Clin Pharmacokinet. 25 June 2019. IF=4.604
23. “固定劑量復方藥品的開發”研討會報告：考慮胃腸生理學的影響和整體發展戰略
“Development of Fixed Dose Combination Products” Workshop Report: Considerations of Gastrointestinal Physiology and Overall Development Strategy.
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
24. 生物藥劑學分類系統BCS 和基于藥物體內處置的生物藥劑學分類系統BDDCS：超出指導原則的情況
The Biopharmaceutics Classification System (BCS) and the Biopharmaceutics Drug Disposition Classification System (BDDCS): Beyond guidelines.
Charalabidis A, Sfouni M, Bergstrom CAS, Macheras P. Int J Pharm. May 17, 2019.IF=4.845
25. 基于生理藥代動力學PBPK 模型預測首次人體PK 的新策略及幾個有挑戰性的工業界案例
Physiologically Based Pharmacokinetic Modelling for First-In-Human Predictions: An Updated Model Building Strategy Illustrated with Challenging Industry Case Studies.
Miller NA, Reddy MB, Heikkinen AT, Lukacova V, Parrott N. Clin Pharmacokinet.Feb 7, 2019. IF=4.604
26. 化妝品安全評估中毒理學關注內部閾值（iTTC）面臨的挑戰：化妝品歐洲iTTC 研討會的相關討論要點
Ellison CA, Blackburn KL, Carmichael PL, Clewell HJ 3rd, Cronin MTD, Desprez B, Escher SE, Ferguson SS, Gregoire SL, Hewitt NJ, Hollnagel HM, Klaric M, Patel A, Salhi S, Schepk A, Schmitt BG, Wambaugh JF, Worth A. Regul Toxicol Pharmacol.Jan 28, 2019.IF=2.652
27. 生理化合物動力學模型在解決環境化學混合物中的作用：綜述
Role of Physiologically Based Kinetic modelling in addressing environmental chemical mixtures – a review.
Desalegn A, Bopp S, Asturiol D, Lamon L, Worth A, Paini A. Computational Toxicology. Oct 1, 2018. CiteScore=2.5
28. 使用生物相關溶出方法和PBPK 建模來預測口服藥物吸收
Use of Biorelevant Dissolution and PBPK Modeling to Predict Oral Drug Absorption.
Kaur N, Narang AS, Kumar Bansal A. Eur J Pharm Biopharm. 2018 Aug; 129:222-246. IF=4.604
29. 生理藥代動力學PBPK 模型在固體藥物納米顆粒轉化中的新興作用
The emerging role of physiologically based pharmacokinetic modelling in solid drug nanoparticle translation.
Siccardi M, Rannard S, Owen A. Adv Drug Deliv Rev. 2018 Jun;131:116-121.IF=13.3
30. 生理藥代動力學PBPK 模型在腫瘤藥物開發中的應用及其準確性：系統性的綜述
Utility of physiologically based pharmacokinetic (PBPK) modeling in oncology drug development and its accuracy: a systematic review.
Saeheng T, Na-Bangchang K, Karbwang J. Eur J Clin Pharmacol. 2018 Nov;74(11):1365-1376. IF=2.641
31. 在評估兒科口服藥品中生物藥劑學的考慮因素-PEARRL 綜述
Biopharmaceutical considerations in paediatrics with a view to the evaluation of orally administered drug products – a PEARRL review.
Guimar?es M, Statelova M, Holm R, Reppas C, Symilllides M, Vertzoni M, Fotaki N.J Pharm Pharmacol. 2018 Jul 3. IF=2.571
32. 在兒科藥物開發中使用生理藥代動力學PBPK 模型的最新研究進展
State-of-the-Art Review on Physiologically Based Pharmacokinetic Modeling in Pediatric Drug Development.
Yellepeddi V, Rower J, Liu X, Kumar S, Rashid J, Sherwin CMT. Clinical Pharmacokinetics. 2018 May 18; pp 1–13. IF=4.604
33. 用于高通量篩選中優先順序和決策的體外到體內轉化IVIVE
In vitro to in vivo extrapolation for high throughput prioritization and decision making.
Bell SM, Chang X, Wambaugh JF, Allen DG, Bartels M,et,al. Toxicol In Vitro. 2018 Mar; 47:213-227. IF=2.959
34. 在提交給法規的申請資料中，采用生理藥代動力學PBPK 模型的資質和結果報告的流程：來自聯盟的觀點
Physiologically Based Pharmacokinetic Model Qualification and Reporting Procedures for Regulatory Submissions: A Consortium Perspective.
Mohamad Shebley, Punam Sandhu, Arian Emami Riedmaier, Masoud Jamei, Rangaraj Narayanan, Aarti Patel, et al. Clin Pharmacol Ther. 2018 Jul; 104(1): 88–110. IF=6.565
35. 使用PBPK 模型預測口服藥物的吸收：微綜述
Predicting Oral Drug Absorption: Mini Review on Physiologically-Based Pharmacokinetic Models.
Louis Lin, Harvey Wong. Pharmaceutics. 2017 Dec; 9(4): 41. IF=4.421
36. 通過生理藥代動力學PBPK 模型對藥物納米顆粒進行建模
Li M, Zou P, Tyner K, et al. AAPS J. 2017: 1-17. IF= 3.737
37. IMI-口服藥物生物藥劑學方法項目-評價自下而上的PBPK 方法預測的成功率的第1 部分：對歐盟口服生物藥劑學工具OrBiTo 化合物數據庫的表征（測試）
IMI–oral biopharmaceutics tools project– evaluation of bottom-up PBPK prediction success part 1: Characterisation of the OrBiTo database of compounds.
Margolskee A, Darwich A S, Pepin X, et al. EUR J Pharm Sci, 2017, 96: 598-609.IF=3.616
38. IMI-口服藥物生物藥劑學方法項目-評價自下而上的PBPK 方法預測的成功率的第2 部分：模擬訓練的介紹和結果的概述
Margolskee A, Darwich A S, Pepin X, et al. EUR J Pharm Sci, 2017, 96: 610-625.IF=3.616
39. IMI-口服藥物生物藥劑學方法項目-評價自下而上的PBPK 方法預測的成功率的第3 部分：通過對不同類別化合物的計算機預測In Silico 性能分析，鑒定系統參數中與目標的差距
Darwich A S, Margolskee A, Pepin X, et al. EUR J Pharm Sci, 2017, 96: 626-642.IF=3.616
40. 藥物在胃腸道的行為和ADME 現象：II-計算機模擬
Gastrointestinal behavior and ADME phenomena: II. In silico simulation.
Lamberti G, Cascone S, Marra F, Titomanlio G, d’Amore M, Barba AA. (2016). J Drug Del. Sci. and Tech. 35:165, IF=2.734
41. 在制藥行業和監管科學中使用生理相關的生物藥劑學工具：當下的狀況及存在的差距？
Use of physiologically relevant biopharmaceutics tools within the pharmaceutical industry and in regulatory sciences: Where are we now and what are the gaps?
Flanagan T, Van Peer A, Lindahl A. (2016) Eur J Pharm Sci. 91:84-90. IF=3.616
42. PBPK 建模與模擬在藥物研究與開發中的應用
Zhuang X, Lu C. (2016). Acta Pharmaceutica Sinica B. June 23. IF=7.097
43. 生理藥代動力學PBPK 建模和模擬的方法：對已公開的模型，應用和模型驗證的系統性綜述
Physiologically Based Pharmacokinetic (PBPK) Modeling and Simulation Approaches: A systematic review of published models, applications and model verification.
Sager JE, Yu J, Raguenau-Majlessi I, Isoherranen N. (2015). Drug Metab Dispos.Aug 21. IF=3.231
44. 藥物在穿越體外和體內屏障時，滲透的定量方法
Quantitative aspects of drug permeation across in vitro and in vivo barriers.
Kr?mer SD. (2015) Eur J Pharm Sci. Oct 19. IF=3.616
45. 采用生理藥代動力學PBPK 模型預測雙環醇控釋制劑在人體的PK
Application of physiologically based pharmacokinetic modeling in the prediction of pharmacokinetics of bicyclol controlled-release formulation in human.
Wang B, Liu Z, Li D, Yang S, Hu J, Chen H, Sheng L, Li Y. (2015). Eur J Pharm Sci.Jun 24. IF=3.616
46. 制藥工業界關于口服制劑處方篩選的方法學
Methodology of oral formulation selection in the pharmaceutical industry.
Kuentz M, Holm R, Elder DP. (2015) Eur J Pharm Sci. Dec 11. IF=3.616
47. 在質量源于涉及范式下，使用吸收模型進行合理的藥物設計
Kesisoglou F, Mitra A. (2015) AAPS J. May 22. IF= 3.737
48. 采用PBPK 模型預測口服劑型的體內性能
PBPK models for the prediction of in vivo performance of oral dosage forms.
Kostewicz ES, Aarons L, Bergstrand M, Bolger MB, Galetin A, Hatley O, Jamei M, Lloyd R,Pepin X, Rostami A, Sj?gren E, Tannergren C, Turner DB, Wagner C, Weitschies W, Dressman J. (2013) Eur J Pharm Sci. Sep 21. IF=3.616
49. 使用計算機預測的參數預測藥物的PK 曲線
Predicting Pharmacokinetic Profiles Using In Silico Derived Parameters.
Hosea NA, Jones HM. (2013). Mol Pharmaceut. Feb 21. IF=4.321
50. 采用建模的方法驅動口服藥物的高效設計
The Use of Modeling Tools to Drive Efficient Oral Product Design.
Mathias NR, Crison J. (2012). AAPS J. May 30. IF= 3.737
51. 生理藥代動力學PBPK 模型：方法論，應用和局限性，重點關注其在兒科藥物開發中的作用
Khalil F, L?er S.(2011) J Biomed Biotechnol. 2011: 907461. IF=2.44
52. 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
Zhang X, Lionberger RA, Davit BM, Yu LX. (2011) AAPS J. 13(1):59-71. IF= 3.737
53. 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
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
54. 生理藥代動力學PBPK 建模與模擬在法規監管審評中的應用
Clin Pharmacol Ther. 89(2):259-67. IF=6.565
55. 輝瑞在藥物發現和開發階段使用PBPK 建模的簡介
Application of PBPK modelling in drug discovery and development at Pfizer.
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