GastroPlus在考察食物效應的應用文章 （2013—2020）

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凡默谷技術部精取了2013-2020年10月GastroPlus在考察食物效應的應用文章33篇。

其中編號1-7 的文章是2019年8月-2020年10月新增的文章。

希望對您的業務或專業學習有所幫助。內容如下：

1.   生理藥代動力學PBPK模型在預測藥物-食物相互作用中的應用：行業觀點

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藥劑學模型（PBBM）預測速釋制劑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.  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

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

4.  預測進食狀態和粒度對ODM-204吸收的影響

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.

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，探討食物和胃液pH值變化對恩曲替尼Entrectinib藥代動力學的影響

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.   用于評價食物對15mg泰勒地平Tylerdipine片劑在健康男性受試者中單次給藥的藥代動力學影響的隨機，開放，交叉設計I期臨床研究

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.   建立標準化的臨床前豬模型以預測食物效應-以非諾貝特和對乙酰氨基酚為案例

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.   采用生理模型評價食物對克拉霉素速釋片口服吸收的影響

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.  在仿制藥開發中，通過PBPK吸收模型評估BCS 2類藥物晶型和無定形兩種制劑處方的食物效應和生物等效性

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, Bo?tjan P, Aleksander B, Albin K. AAPS PharmSciTech.Jan 8, 2019. IF=2.401

11.  用于評估膳食對緩釋制劑釋放的影響的生理學考慮和體外策略

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.  通過生理藥代動力學PBPK模型預測食物效應：用于前瞻性項目研究

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.  在長期服用厄洛替尼erlotinib的期間，監測在胰腺癌患者中的行為，并與生理藥代動力學PBPK模型的預測結果進行比較

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.  對于食物的思考：如何利用制劑處方中避免食物效應-PEARRL綜述

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.  探討小型豬的胃排空速率：食物類型和預先給藥（甲氧氯普胺）對胃排空的影響

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抑制劑sapanisertib（TAK-228）口服研磨制劑的I期研究：在晚期實體瘤患者中的耐受性和食物效應

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.  聯用“自下而上”和“自上而下”的方法評估食物和胃液pH對Pictilisib （GDC-0941）PK的影響

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.   食物效應在藥物與膳食同服的兒科藥品開發中的影響

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.   食物對藥物口服生物利用度的影響：舊和新的問題

Food Effect on Oral Bioavailability: Old and New Questions. 

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

20.  使用PBPK模型預測化合物A片劑的食物效應的機理

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.  引起唑吡坦調釋制劑負向的食物效應的機理考察

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.  食物效應：綜合考察介質pH和粘度對環丙沙星片在胃腸道吸收的影響

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.  開發用于描述在空腹和餐后條件下氯吡格雷片劑給藥的體外體內相關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.  采用基于生理學的吸收模型，探討食物和胃液pH值變化對艾樂替尼Alectinib PK的影響

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.  解密硝苯地平調釋制劑在體內的遞送：食物效應的鑒定

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.  通過體外溶出和體內PK模型預測食物效應在人體內的風險

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.  通過脂質分散體降低非諾貝特口服生物利用度的食物依賴性：采用體外、體內和計算機模擬三種方法進行評估

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.  從實驗室到人體用藥：降低難溶性藥物食物效應的制劑處方開發

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.  改善曲司氯銨Trospium在人空腹和餐后狀態下的特異性吸收模型

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.  粘性導致低滲透性口服藥物產生負向食物效應并在近端腸段產生吸收窗：通過體驗試驗進行模擬和計算機方法進行驗證

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.  基于生理學的吸收模型在低溶解度，低滲透性弱堿藥物制劑處方開發中的應用：食物效應的機理研究

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.  采用基于生理學的模型和臨床前的體外/體內數據，來降低BCS 2類化合物的正向食物效應

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.  導致BCS III類化合物固體直接負向食物效應的機理研究

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 

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