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凡默谷技術(shù)部選取和匯總了2015-2020年制劑體外崩解與溶出模擬軟件DDDPlus發(fā)表的應(yīng)用文章，并將標(biāo)題翻譯成中文。

希望對(duì)您的業(yè)務(wù)或?qū)I(yè)學(xué)習(xí)有所幫助，內(nèi)容如下：

1.   采用基于生理的吸收模型，探討食物和胃液pH值變化對(duì)恩曲替尼Entrectinib藥代動(dòng)力學(xué)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

2.  使用基于生理的生物藥劑學(xué)模型（PBBM）預(yù)測(cè)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.  制劑處方開(kāi)發(fā)早期的無(wú)定型固體分散劑：使用DDDPlus預(yù)測(cè)輔料對(duì)溶出曲線的影響

Amorphous Solid Dispersions in Early Stage of Formulation Development: Predicting Excipient Influence on Dissolution Profiles Using DDDPlus.

Njoku JO, Mukherjee D, Webster GK, L?benberg R. Dissolut Technol.MAY 2020. IF= 0.674

4.   藥物制劑早期開(kāi)發(fā)的計(jì)算機(jī)預(yù)測(cè)工具：所需的數(shù)據(jù)和軟件的功能

In silico Tools at Early Stage of Pharmaceutical Development: Data Needs and Software Capabilities.

Njoku JO, Amaral Silva D, Mukherjee D, Webster GK, L?benberg R.AAPS PharmSciTech. (2019) 20: 243. IF=2.401

5.   采用生理藥代動(dòng)力學(xué)PBPK模型，評(píng)估影響美托洛爾緩釋藥品生物等效性的制劑因素

Physiologically Based Pharmacokinetic Modeling to Evaluate Formulation Factors Influencing Bioequivalence of Metoprolol Extended-Release Products.

Sumit Basu, Haitao Yang, Lanyan Fang, Mario Gonzalez‐Sales, Liang Zhao, Mirjam N. Trame, Lawrence Lesko, Stephan Schmid. J Clin Pharmacol. Volume59, Issue9. September 2019 Pages 1252-1263. IF=2.425

6.  評(píng)估制劑處方變異對(duì)臨床的影響：以美托洛爾緩釋制劑作為研究案例

Evaluating the Clinical Impact of Formulation Variability: A Metoprolol Extended‐Release Case Study. 

Kim S, Sharma VD, Lingineni K, Farhan N, Fang L, Zhao L, Brown J, Cristofoletti R, Vozmediano V, Ait-Oudhia S, Lesko LJ, Trame MN, Schmidt S. J Clin Pharmacol. May 14, 2019. IF=2.425

7.   建立體外-體內(nèi)相關(guān)的溶出和轉(zhuǎn)化建模策略-某研討會(huì)總結(jié)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

8.   用于體外-體內(nèi)外推轉(zhuǎn)化IVIVE的生理藥代動(dòng)力學(xué)PBPK建模：強(qiáng)調(diào)溶出數(shù)據(jù)的使用

Physiologically Based Pharmacokinetic (PBPK) Modelling for In Vitro-In Vivo Extrapolation: Emphasis on the Use of Dissolution Data

Vivek M. Ghate, Pinal Chaudhari, and Shaila A. Lewis. Dissolut Technol. August 2019. IF= 0.674

9.   藥品開(kāi)發(fā)中的溶出測(cè)試：研討會(huì)總結(jié)報(bào)告

Dissolution Testing in Drug Product Development: Workshop Summary Report

Andreas Abend, David Curran, Jesse Kuiper, Xujin Lu, Hanlin Li, Andre Hermans, Pramod Kotwal, Dorys A Diaz, Michael J Cohen, Limin Zhang, Erika Stippler, German Drazer, Yiqing Lin, Kimberly Raines, Lawrence Yu, Carrie A Coutant, Haiyan Grady, Johannes Kr?mer, Sarah Pope-Miksinski, Sandra Suarez-Sharp. AAPS J. 2019 Jan 28;21(2):21. IF=3.737

10.   通過(guò)計(jì)算機(jī)模擬溶出曲線，開(kāi)發(fā)多沙唑嗪緩釋片

In Silico Simulation of Dissolution Profiles for Development of Extended-Release Doxazosin Tablets.

Duque MD, Issa MG, Silva DA, Barbosa EJ, L?benberg R, Ferraz HG.Dissolut Technol. NOVEMBER 2018. IF= 0.674

11.  用于評(píng)估膳食對(duì)緩釋制劑釋放的影響的生理學(xué)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.   采用體外方法評(píng)估空腹?fàn)顟B(tài)下，藥物在小腸中的沉淀-PEARRL綜述

In vitro methods to assess drug precipitation in the fasted small intestine – a PEARRL review. 

O’Dwyer PJ, Litou C, Box KJ, Dressman JB, Kostewicz ES, Kuentz M, Reppas C. J Pharm Pharmacol. 2018 Jun 28. IF=2.571

13.   溶出過(guò)程中，十二烷基硫酸鈉載藥不完全和分散顆粒劑的擴(kuò)散層內(nèi)的空腹?fàn)顟B(tài)下的模擬腸液膠束

Incomplete Loading of Sodium Lauryl Sulfate and Fasted State Simulated Intestinal Fluid Micelles Within the Diffusion Layers of Dispersed Drug Particles During Dissolution

Kendra Galipeau, Michael Socki, Adam Socia, Paul A. Harmon.Journal of Pharmaceutical Sciences. 107 (2018) 156-169. IF=2.997

14.  針對(duì)BCS溶解度分類(lèi)的高溶解度和難溶性藥物的固有溶出度模擬

Intrinsic dissolution simulation of highly and poorly soluble drugs for BCS solubility classification.  

Duque MD, Issa MG, Silva DA, Kakuda BAS, Rodrigues LNC, L?benberg R, Ferraz HG. Dissolution Technologies. 2017 Nov.IF=0.674

15.  使用體外和計(jì)算機(jī)模擬模型證明超出FDA標(biāo)準(zhǔn)范圍的崩解測(cè)試方法的可行性

Justification of disintegration testing beyond current FDA criteria using in vitro and in silico models

Lukas Uebbing, Lukas Klumpp, Gregory K Webster, Raimar L?benberg. Drug Design, Development and Therapy. April 2017.IF=3.216

16.   采用DDDPlus?模擬藥物的體外溶出行為

Simulation of In Vitro Dissolution Behavior Using DDDPlus?

Almukainzi M, Okumu A, Wei H, L?benberg R. AAPS PharmSciTech.Feb, 2015. IF=2.401

17.  體外-體內(nèi)相關(guān)性IVIVC：通用概念，方法，在法規(guī)監(jiān)管中的應(yīng)用

In vitro–in vivo correlations: general concepts, methodologies and regulatory applications [J]. 

González-García I, Mangas-Sanjuán V, Merino-Sanjuán M, et al. Drug development and industrial pharmacy, 2015, 41(12): 1935-1947. IF=2.365

18. 生物相關(guān)性溶出度方法研究進(jìn)展

繆慧，阮昊，陳悅，洪利婭. 《中國(guó)現(xiàn)代應(yīng)用藥學(xué)》. 2018,35(01). 綜合影響因子：1.2