GastroPlus在考察食物效应的应用文章 （2013—2020）

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凡默谷技术部精取了2013-2020年10月GastroPlus在考察食物效应的应用文章33篇。

其中编号1-7 的文章是2019年8月-2020年10月新增的文章。

希望对您的业务或专业学习有所帮助。内容如下：

1.   生理药代动力学PBPK模型在预测药物-食物相互作用中的应用：行业观点

Use of Physiologically Based Pharmacokinetic (PBPK) Modeling for Predicting Drug-Food Interactions: an Industry Perspective.

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.   使用基于生理的生物药剂学模型（PBBM）预测速释制剂空腹和餐后的生物等效性

Prediction of fasted and fed bioequivalence for immediate release drug products using physiologically based biopharmaceutics modeling (PBBM).

Jereb R, Kristl A, Mitra A. Eur J Pharm Sci. Volume 155, 1 December 2020, 105554.IF= 3.616

3.  药物开发过程中，当前食物效应预测方法的综述

A Review of Current Methods for Food Effect Prediction During Drug Development

Zhang T, Wells E. Curr Pharmacol Rep. 6, pages267–279(2020).

4.  预测进食状态和粒度对ODM-204吸收的影响

Predicting the effect of prandial stage and particle size on absorption of ODM-204.

Ojala K, Schilderink R, Nykanen P, van Veen B, Malmstrom C, Juppo A, Korjamo T.Eur J Pharm Biopharm. Volume 156, November 2020, Pages 75-83. IF= 4.604

5.   食物对药物口服吸收的影响：生理药代动力学PBPK模型作为预测工具的应用

Food Effects on Oral Drug Absorption: Application of Physiologically-Based Pharmacokinetic Modeling as a Predictive Tool.

Cheng L, Wong H. Pharmaceutics. 2020, 12(7), 672;17 July 2020. IF=4.421

6.   采用基于生理的吸收模型，探讨食物和胃液pH值变化对恩曲替尼Entrectinib药代动力学的影响

Physiologically Based Absorption Modelling to Explore the Impact of Food and Gastric pH Changes on the Pharmacokinetics of Entrectinib.

Parrott N, Stillhart C, Lindenberg M, Wagner B, Kowalski K, Guerini E, Djebli N, Meneses-Lorente G. AAPS J (2020) 22:78. IF= 3.737

7.   用于评价食物对15mg泰勒地平Tylerdipine片剂在健康男性受试者中单次给药的药代动力学影响的随机，开放，交叉设计I期临床研究

A Randomized, Open‐Label, Crossover Phase 1 Study to Evaluate the Effects of Food on the Pharmacokinetics of a Single Oral Dose of a 15‐mg Tylerdipine Tablet in Healthy Chinese Male Volunteers.

Lu Wang, Lijun Xie, Sufeng Zhou, Yuanyuan Wang, Juan Chen, Yanli Zhou, Yun Liu, Hongwen Zhang, Mingxue Tao, Ning Ou, Feng Shao. Clin Pharmacol Drug Dev.2019 Jan;8(1):126-132. IF=1.903

8.   建立标准化的临床前猪模型以预测食物效应-以非诺贝特和对乙酰氨基酚为案例

Toward the establishment of a standardized pre-clinical porcine model to predict food effects – Case studies on fenofibrate and paracetamol. 

Henze LJ, Koehl NJ, O’Shea JP, Holm R, Vertzoni M, Griffin BT. Int J Pharm. May 28, 2019. IF=4.845

9.   采用生理模型评价食物对克拉霉素速释片口服吸收的影响

Evaluation of Food Effect on the Oral Absorption of Clarithromycin from Immediate Release Tablet using Physiological Modelling. 

Radwan A, Jayyousi R, Shraim N, Naser Zaid A. Biopharm Drug Dispos. Mar 19, 2019. IF=1.663

10.  在仿制药开发中，通过PBPK吸收模型评估BCS 2类药物晶型和无定形两种制剂处方的食物效应和生物等效性

PBPK Absorption Modeling of Food Effect and Bioequivalence in Fed State for Two Formulations with Crystalline and Amorphous Forms of BCS 2 Class Drug in Generic Drug Development. 

Rebeka J, Jerneja O, Igor L, Boštjan P, Aleksander B, Albin K. AAPS PharmSciTech.Jan 8, 2019. IF=2.401

11.  用于评估膳食对缓释制剂释放的影响的生理学考虑和体外策略

Physiological Considerations and In Vitro Strategies for Evaluating the Influence of Food on Drug Release from Extended-Release Formulations. 

Koziolek M, Kostewicz ES, Vertzoni M. AAPS PharmSciTech. Aug 28, 2018.IF=2.401

12.  通过生理药代动力学PBPK模型预测食物效应：用于前瞻性项目研究

Food Effect Projections via Physiologically Based Pharmacokinetic Modeling: Predictive Case Studies. 

Tistaert C, Heimbach T, Xia B, Parrott N, Samant TS, Kesisoglou F. J Pharm Sci. Jun 12, 2018. IF=3.616

13.  在长期服用厄洛替尼erlotinib的期间，监测在胰腺癌患者中的行为，并与生理药代动力学PBPK模型的预测结果进行比较

Monitoring of erlotinib in pancreatic cancer patients during long-time administration and comparison to a physiologically based pharmacokinetic model.

Gruber A, Czejka M, Buchner P, Kitzmueller M, Kirchbaumer Baroian N, Dittrich C, Sahmanovic Hrgovcic A. Cancer Chemother Pharmacol. 2018 Apr; 81(4):763-771.IF=3.008

14.  对于食物的思考：如何利用制剂处方中避免食物效应-PEARRL综述

Food for thought: formulating away the food effect – a PEARRL review. 

O’Shea JP, Holm R, O’Driscoll CM, Griffin BT. J Pharm Pharmacol. 2018 Jun 28.IF=2.39

15.  探讨小型猪的胃排空速率：食物类型和预先给药（甲氧氯普胺）对胃排空的影响

Exploring gastric emptying rate in minipigs: Effect of food type and pre-dosing of metoclopramide. 

Henze LJ, Griffin BT, Christiansen M, Bundgaard C, Langguth P, Holm R. Eur J Pharm Sci. 2018 Jun 15;118:183-190. IF=3.616

16.   mTORC1 / 2抑制剂sapanisertib（TAK-228）口服研磨制剂的I期研究：在晚期实体瘤患者中的耐受性和食物效应

Phase I study of the investigational oral mTORC1/2 inhibitor sapanisertib (TAK-228): tolerability and food effects of a milled formulation in patients with advanced solid tumours.

Moore KN, Bauer TM, Falchook GS, Chowdhury S, Patel C, Neuwirth R, Enke A, Zohren F, Patel MR. ESMO Open. 2018 Feb 1;3(2): e000291.

17.  联用“自下而上”和“自上而下”的方法评估食物和胃液pH对Pictilisib （GDC-0941）PK的影响

Combining “Bottom-up” and “Top-down” Approaches to Assess the Impact of Food and Gastric pH on Pictilisib (GDC-0941) Pharmacokinetics.

Lu T, Fraczkiewicz G, Salphati L, Budha N, Dalziel G, Smelick GS, Morrissey KM, Davis JD, Jin JY, Ware JA. CPT Pharmacometrics Syst Pharmacol. 2017 Nov;6(11):747-755. CiteScore=5.2

18.   食物效应在药物与膳食同服的儿科药品开发中的影响

Food effects in paediatric medicines development for products Co-administered with food. 

Batchelor H, Kaukonen A M, Klein S, et al. Int J Pharm. Feb 5, 2018. IF=4.845

19.   食物对药物口服生物利用度的影响：旧和新的问题

Food Effect on Oral Bioavailability: Old and New Questions. 

Yan J H. Clin Pharmacol Drug Dev, 2017. IF=1.903

20.  使用PBPK模型预测化合物A片剂的食物效应的机理

Mechanistic prediction of food effects for Compound A tablet using PBPK model.

Li X, Shi L, Tang X, et al. Saudi journal of biological sciences, 2017, 24(3): 603-609. IF=2.802

21.  引起唑吡坦调释制剂负向的食物效应的机理考察

Mechanistic investigation of the negative food effect of modified release zolpidem [J]. 

Andreas C J, Pepin X, Markopoulos C, et al. European Journal of Pharmaceutical Sciences, 2017, 102: 284-298. IF=3.616

22.  食物效应：综合考察介质pH和粘度对环丙沙星片在胃肠道吸收的影响

Food effect: The combined effect of media pH and viscosity on the gastrointestinal absorption of ciprofloxacin tablet [J]. 

Radwan A, Zaid A N, Jaradat N, et al. European Journal of Pharmaceutical Sciences, 2017, 101: 100-106. IF=3.616

23.  开发用于描述在空腹和餐后条件下氯吡格雷片剂给药的体外体内相关IVIVC模型

Development of in vitro in vivo correlation models for clopidogrel tablets to describe administration under fasting and fed conditions. 

Savu S N, Silvestro L, Mircioiu C, et al. Farmacia, 2016, 11(16): 18. IF=1.5607  

24.  采用基于生理学的吸收模型，探讨食物和胃液pH值变化对艾乐替尼Alectinib PK的影响

Physiologically Based Absorption Modeling to Explore the Impact of Food and Gastric pH Changes on the Pharmacokinetics of Alectinib [J]. 

Parrott N J, Li J Y, Takano R, et al. The AAPS journal, 2016, 18(6): 1464-1474. IF=3.737 

25.  解密硝苯地平调释制剂在体内的递送：食物效应的鉴定

Deciphering nifedipine in vivo delivery from modified release dosage forms: Identification of food effect. Ilic M, Kovacevic I, Parojcic J. (2015). Acta Pharm.65:427. IF=1.375

26.  通过体外溶出和体内PK模型预测食物效应在人体内的风险

Food Effect in Humans: Predicting the Risk Through In Vitro Dissolution and In Vivo Pharmacokinetic Models. 

Mathias N, Xu Y, Vig B, Kestur U, Saari A, Crison J, Desai D, Vanarase A, Hussain M. (2015). AAPS J. May 2. IF=3.737  

27.  通过脂质分散体降低非诺贝特口服生物利用度的食物依赖性：采用体外、体内和计算机模拟三种方法进行评估

Lipidic dispersion to reduce food dependent oral bioavailability of fenofibrate: in vitro, in vivo and in silico assessments.

O’Shea JP, Faisal W, Ruane-O’Hora T, Devine KJ, Kostewicz ES, O’Driscoll CM, Griffin BT. Eur J Pharm Biopharm. Oct 1, 2015. IF=4.604

28.  从实验室到人体用药：降低难溶性药物食物效应的制剂处方开发

From Bench to Humans: Formulation Development of a Poorly Water Soluble Drug to Mitigate Food Effect.

Pandey P, Hamey R, Bindra DS, Huang Z, Mathias N, Eley T, Crison J, Yan B, Perrone R, Vemavarapu C. (2014). AAPS PharmSciTech. Jan 18. IF=2.401

29.  改善曲司氯铵Trospium在人空腹和餐后状态下的特异性吸收模型

Improvement of trospium-specific absorption models for fasted and fed states in humans. 

Cvijic S, Langguth P. (2014). Biopharm Drug Dispos. Jul 17. IF=1.663

30.  粘性导致低渗透性口服药物产生负向食物效应并在近端肠段产生吸收窗：通过体验试验进行模拟和计算机方法进行验证

Viscosity-mediated negative food effect on oral absorption of poorly-permeable drugs with an absorption window in the proximal intestine: In vitro experimental simulation and computational verification. 

Cvijic S, Parojcic J, Langguth P. (2014). Eur J Pharm Sci. Apr 18. IF=3.616

31.  基于生理学的吸收模型在低溶解度，低渗透性弱碱药物制剂处方开发中的应用：食物效应的机理研究

Application of Physiologically Based Absorption Modeling to Formulation Development of a Low Solubility, Low Permeability Weak Base: Mechanistic Investigation of Food Effect. 

Zhang H, Xia B, Sheng J, Heimbach T, Lin TH, He H, Wang Y, Novick S, Comfort A. (2014). AAPS PharmSciTech. Jan 17. IF=2.401 

32.  采用基于生理学的模型和临床前的体外/体内数据，来降低BCS 2类化合物的正向食物效应

Utility of Physiologically Based Modeling and Preclinical In Vitro/In Vivo Data to Mitigate Positive Food Effect in a BCS Class 2 Compound. 

Xia B, Heimbach T, Lin TH, Li S, Zhang H, Sheng J, He H. (2013). AAPS PharmSciTech. Aug. 17. IF=2.401 

33.  导致BCS III类化合物固体直接负向食物效应的机理研究

Mechanistic Investigation of Negative Food Effect for BCS Class III Compounds in Solid Dosage Forms.

Radwan A. Mol Pharm. Apr 1, 2013. IF=4.321