Northern Science Consulting Inc.

ノーザンサイエンスコンサルティング株式会社

お問い合わせ


薬物動態解析・製剤設計支援ソフトウエア

開発元:

ヒトおよび各種動物への経口、静注、口腔内、眼、吸入、経皮、筋肉内、関節内投与における薬物の体内挙動をシミュレーションします。 吸収スクリーニング、薬物動態解析、製剤開発・設計、IVIVC評価、仮想母集団を用いた模擬臨床試験など、創薬の初期から開発まで広く利用可能なモデリング&シミュレーションソフトウェアです。

  GastroPlus® Core パンフレット

  GastroPlus® オプションモジュール パンフレット
Selected References

GastroPlus® が用いられている代表的な文献を以下にリストしています。


| 2017 | 2016 | 2015 | 2014 | 2013 | 2012 | 2011 | 2010 | 2009 | 2008 | 2007 | 2006 | 2005 | 2004 | 2003 | 2002 | 2001 |

2017

In vitro dissolution models for the prediction of in vivo performance of an oral mesoporous silica formulation.
McCarthy CA, Faisal W, O'Shea JP, Murphy C, Ahern RJ, Ryan KB, Griffin BT, Crean AM
J Control Release. 2017 Mar 28;250:86-95.
In Vitro Evaluation of Absorption Characteristics of Peramivir for Oral Delivery
Li Y, Wang Z, Li X, Gong W, Xie X, Yang Y, Zhong W, Zheng A
Eur J Drug Metab Pharmacokinet. 2017 Oct;42(5):757-765.
In vitro dissolution models for the prediction of in vivo performance of an oral mesoporous silica formulation.
McCarthy CA, Faisal W, O'Shea JP, Murphy C, Ahern RJ1, Ryan KB, Griffin BT, Crean AM
J Control Release. 2017 Mar 28;250:86-95
Biopharmaceutics data management system for anonymised data sharing and curation: First application with orbito IMI project.
Kristin Lacy-Jones, Philip Hayward, Steve Andrews, Ian Gledhill, Mark McAllister, Bertil Abrahamsson, Amin Rostami-Hodjegan, Xavier Pepin
Computer Methods and Programs in Biomedicine. Volume 140, March 2017, Pages 29-44
Physiologically Based Pharmacokinetic (PBPK) Modeling of Pharmaceutical Nanoparticles.
Min Li, Peng Zou, Katherine Tyner, Sau Lee
The AAPS Journal. January 2017, Volume 19, Issue 1, pp 26–42
Exploring and validating physicochemical properties of mangiferin through GastroPlus® software.
Rajneet Kaur Khurana, Ranjot Kaur, Manninder Kaur, Rajpreet Kaur, Jasleen Kaur, Harpreet Kaur, Bhupinder Singh
Future Science OA, 16 Jan 2017, Vol. 3, No. 1
In silico-in vitro-in vivo studies of experimentally designed carvedilol loaded silk fibroin-casein nanoparticles using physiological based pharmacokinetic model.
Sandeep Kumar, Sandeep Kumar Singh
International Journal of Biological Macromolecules. March 2017, Pages 403-420
Quantitative analysis of lab-to-lab variability in Caco-2 permeability assays.
Jong Bong Lee, Atheer Zgair, Dhiaa A. Taha, Xiaowei Zang, Leonid Kagan, Tae Hwan Kim, Min Gi Kim, Hwi-yeol Yun, Peter M. Fischer, Pavel Gershkovich
European Journal of Pharmaceutics and Biopharmaceutics. Volume 114, May 2017, Pages 38-42
Prediction of pharmacokinetics and drug-drug interaction potential using physiologically based pharmacokinetic (PBPK) modeling approach: A case study of caffeine and ciprofloxacin.
Min-Ho Park, Seok-Ho Shin, Jin-Ju Byeon, Gwan-Ho Lee, Byung-Yong Yu, Young G. Shin
Korean J Physiol Pharmacol. 2017 Jan;21(1):107-115.
Report from EMA Workshop on Qualification and Reporting of Physiologically‐based Pharmacokinetic (PBPK) Modelling and Simulation.
P Zhao
CPT: Pharmacometrics & Systems Pharmacology. Volume 6, Issue 2, 3 February 2017, Pages 71–72
Food effect: The combined effect of media pH and viscosity on the gastrointestinal absorption of ciprofloxacin tablet.
Radwan A, Zaid AN, Jaradat N, Odeh Y
Eur J Pharm Sci. 1 April 2017, Pages 100-106
Influence of different proton pump inhibitors on the pharmacokinetics of voriconazole.
Qi F, Zhu L, Li N, Ge T, Xu G, Liao S
Int J Antimicrob Agents. 2017 Apr;49(4):403-409.
Progress in Prediction and Interpretation of Clinically Relevant Metabolic Drug-Drug Interactions: a Minireview Illustrating Recent Developments and Current Opportunities.
Fowler S, Morcos PN, Cleary Y, Martin-Facklam M, Parrott N, Gertz M, Yu L (2017)
Curr Pharmacol Rep. February 2017, Volume 3, Issue 1, pp 36–49.
Extension of the dissolution-precipitation model for kinetic elucidation of solvent-mediated polymorphic transformations.
Jakubiak P, Schuler F, Alvarez-Sánchez R
Eur J Pharm Biopharm. Volume 109, December 2016, Pages 43-48.
In vitro dissolution models for the prediction of in vivo performance of an oral mesoporous silica formulation.
Carol A. McCarthy, Waleed Faisal, Joseph P. O'Shea, Colm Murphy, Robert J. Ahern, Katie B. Ryan, Brendan T. Griffin, Abina M. Crean
Journal of Controlled Release. Volume 250, 28 March 2017, Pages 86-95
In Vitro Evaluation of Absorption Characteristics of Peramivir for Oral Delivery.
Li Y, Wang Z, Li X, Gong W, Xie X, Yang Y, Zhong W, Zheng A
Eur J Drug Metab Pharmacokinet. 2017 October;42(5):757-765
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 MN, Mistry B, Lukacova V, Lentz KA, Polli JE, Hoag SW, Dowling T, Kona R, Fahmy RM
AAPS J. May 2017;19(3):712-726.
Mechanistic investigation of the negative food effect of modified release zolpidem.
Andreas CJ, Pepin X, Markopoulos C, Vertzoni M, Reppas C, Dressman JB
Eur J Pharm Sci. Volume 102, 1 May 2017, Pages 284-298.
The impact of reduced gastric acid secretion on dissolution of salts of weak bases in the fasted upper gastrointestinal lumen: Data in biorelevant media and in human aspirates.
Chara Litou, Maria Vertzoni, Wei Xu, Filippos Kesisoglou, Christos Reppas
European Journal of Pharmaceutics and Biopharmaceutics. Volume 115, June 2017, Pages 94-101
The impact of supersaturation level for oral absorption of BCS class IIb drugs, dipyridamole and ketoconazole, using in vivo predictive dissolution system: Gastrointestinal Simulator (GIS).
Yasuhiro Tsume, Kazuki Matsui, Amanda L. Searls, Susumu Takeuchi, Gregory E. Amidon, Duxin Sun, Gordon L. Amidon
European Journal of Pharmaceutical Sciences. Volume 102, 1 May 2017, Pages 126-139
Mechanistic prediction of food effects for Compound A tablet using PBPK model
Xueqing Li, Lei Shi, Xiuling Tang, Qinghui Wang, Lun Zhou, Wei Song, Zhijun Feng, Jie Ge, Jian Kang Li, Lin Yang, Aidong Wen, Yan Zhang
Saudi Journal of Biological Sciences. Volume 24, Issue 3, March 2017, Pages 603-609
Characterising Drug Release from Immediate-Release Formulations of a Poorly Soluble Compound, Basmisanil, Through Absorption Modelling and Dissolution Testing.
Cordula Stillhart, Neil J. Parrott, Marc Lindenberg, Pascal Chalus, Darren Bentley, Anikó Szepes
The AAPS Journal. May 2017, Volume 19, Issue 3, pp 827–836
Food Effect on Oral Bioavailability: Old and New Questions.
Yan JH
Clin Pharmacol Drug Dev. Jul 2017;6(4):323-330.
Identification and characterisation of a salt form of Danirixin with reduced pharmacokinetic variability in patient populations.
Bloomer JC, Ambery C, Miller BE, Connolly P, Garden H, Henley N, Hodnett N, Keel S, Kreindler JL, Lloyd RS, Matthews W, Yonchuk J, Lazaar AL
Eur J Pharm Biopharm. 2017 Aug;117:224-231.
Integrating in vitro, modeling, and in vivo approaches to investigate warfarin bioequivalence.
Zhang X, Wen H, Fan J, Vince B, Li T, Gao W, Kinjo M, Brown J, Sun W, Jiang W, Lionberger R
CPT Pharmacometrics Syst Pharmacol. 2017 Aug;6(8):523-531.
Comparison of oral absorption properties among different bisphosphonates by using a newly developed physiologically based pharmacokinetic model.
Nakai, K, Nakamura, M
Therapeutic Research Volume 38, Issue 3, 311 - 319 (2017)
A strategy for early risk predictions of clinical drug-drug interactions involving the GastroPlusTM DDI module for time-dependent CYP inhibitors.
Sohlenius-Sternbeck AK, Meyerson G, Hagbjörk AL, Juric S, Terelius Y
Xenobiotica. 15 May 2017:1-9.
Lipophilic salts of poorly soluble compounds to enable high-dose lipidic SEDDS formulations in drug discovery.
Morgen M, Saxena A, Chen XQ, Miller W, Nkansah R, Goodwin A, Cape J, Haskell R, Su C, Gudmundsson O, Hageman M, Kumar A, Chowan GS, Rao A, Holenarsipur VK
Eur J Pharm Biopharm. 2017 Aug;117:212-223.
Studies on Core-Shell Nanocapsules of Felodipine: In Vitro-In Vivo Evaluations.
Geroge JK, Verma PRP, Venkatesan J, Lee JY, Yoon DH, Kim SK, Singh SK
AAPS PharmSciTech. 2017 Nov;18(8):2871-2888.
In vitro and in vivo evaluation of gastro-retentive carvedilol loaded chitosan beads using GastroPlus™.
Praveen R, Prasad Verma PR, Venkatesan J, Yoon DH, Kim SK, Singh SK
International Journal of Biological Macromolecules. Volume 102, September 2017, Pages 642-650
Prediction of Losartan Active Carboxylic Acid Metabolite Exposure Following Losartan Administration Using Static and Physiologically-Based Pharmacokinetic Models.
Nguyen HQ, Lin J, Kimoto E, Callegari E, Tse S, Obach RS
Journal of Pharmaceutical Sciences. September 2017, Volume 106, Issue 9, Pages 2758–2770
Development and qualification of physiologically based pharmacokinetic models for drugs with atypical distribution behavior: A desipramine case study.
Samant TS, Lukacova V, Schmidt S
CPT Pharmacometrics Syst Pharmacol. 2017 May;6(5):315-321.
Development of long-circulating docetaxel loaded poly (3-hydroxybutyrate-co-3-hydroxyvalerate) nanoparticles: Optimization, pharmacokinetic, cytotoxicity and in vivo assessments.
Harsh Vardhan, Pooja Mittal, Sandeep K. Reddy Adena, Mansi Upadhyay, Brahmeshwar Mishra
International Journal of Biological Macromolecules. Volume 103, October 2017 , Pages 791-801
Food effects in paediatric medicines development for products co-administered with food.
Hannah Batchelor, Ann Marie Kaukonen, Sandra Klein, Barbara Davit, Rob Ju, Robert Ternik, Tycho Heimbach, Wen Lin, Jian Wang, David Storey
International Journal of Pharmaceutics. Available online 8 May 2017
A cross-species translational pharmacokinetic-pharmacodynamic evaluation of core bodytemperature reduction by the TRPM8 blocker PF-05105679.
James R. Gosset, Kevin Beaumont, Tomomi Matsuura, Wendy Winchester, Neil Attkins, Sophie Glatt, Ian Lightbown, Kristina Ulrich, Sonia Roberts, Jolie Harris, Emir Mesic, Tamara van Steeg, Diana Hijdra, Piet H. van der Graaf
European Journal of Pharmaceutical Sciences. Volume 109, Supplement, 15 November 2017, Pages S161-S167
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.
Jianghong Fan, Xinyuan Zhang, Liang Zhao
The AAPS Jpurnal. September 2017, Volume 19, Issue 5, pp 1479–1486
The Use of In Vitro and In Silico Technologies for Predicting Human Pharmacology and Toxicology of Carfentanil.
Feasel M G (2017)
ProQuest Dissertations Publishing
In vitro–in vivo and pharmacokinetic evaluation of solid lipid nanoparticles of furosemide using GastroPlus™.
Hasan Ali, Priya Ranjan Prasad Verma, Sunil Kumar Dubey, Jayachandran Venkatesan, Youngwan Seo, Se-Kwon Kim, Sandeep Kumar Singh
RSC Adv., 2017, 7, 33314-33326
Calcium Phosphate Particles as Pulmonary Delivery System for Interferon-α in Mice.
Tülin Morçöl Email author, Jessica M. Weidner, Anand Mehta, Stephen J.D. Bell, Timothy Block
AAPS PharmSciTech. January 2018, Volume 19, Issue 1, pp 395–412
Oral product input to the GI tract: GIS an oral product performance technology.
Gordon L. Amidon, Yasuhiro Tsume (2017)
Frontiers of Chemical Science and Engineering. pp 1–5
In Silico Absorption Analysis of Valacyclovir in Wildtype and Pept1 Knockout Mice Following Oral Dose Escalation.
Bei Yang, David E. Smith
Pharmaceutical Research. November 2017, Volume 34, Issue 11, pp 2349–2361
Effect of the pulmonary deposition and in vitro permeability on the prediction of plasma levels of inhaled budesonide formulation.
Sharareh Salar-Behzadi, Shengqian Wu, Annalisa Mercuri, 1, Claudia Meindl, Sandra Stranzinger, Eleonore Fröhlich
International Journal of Pharmaceutics. Volume 532, Issue 1, 30 October 2017, Pages 337-344
Biorelevant Dissolution Models for a Weak Base To Facilitate Formulation Development and Overcome Reduced Bioavailability Caused by Hypochlordyria or Achlorhydria.
Dawen Kou, Sudharsan Dwaraknath, Yannick Fischer, Daniel Nguyen, Myeonghui Kim, Hiuwing Yiu, Preeti Patel, Tania Ng, Chen Mao, Matthew Durk, Leslie Chinn, Helen Winter, Larry Wigman, Peter Yehl
Mol. Pharmaceutics, 2017, 14 (10), pp 3577–3587
Investigating the state of physiologically based kinetic modelling practices and challenges associated with gaining regulatory acceptance of model applications.
Alicia Paini, Jeremy A. Leonard, Tomas Kliment, Yu-Mei Tan, Andrew Worth
Regulatory Toxicology and Pharmacology. Volume 90, November 2017, Pages 104-115
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. Nov 2017;6(11):747-755.
Coupled in silico platform: Computational fluid dynamics (CFD) and physiologically-based pharmacokinetic (PBPK) modelling.
Aleksandra Vulović, Tijana Šušteršič, Sandra Cvijić, Svetlana Ibrić, Nenad Filipović
European Journal of Pharmaceutical Sciences. Available online 17 October 2017
The solubility-permeability trade-off of progesterone with cyclodextrins under physiological conditions: Experimental observations and computer simulations.
Le Sun, Bing Zhang, Jin Sun
Journal of Pharmaceutical Sciences. Volume 107, Issue 1, January 2018, Pages 488-494
Investigating Oral Absorption of Carbamazepine in Pediatric Populations.
Kohlmann P, Stillhart C, Kuentz M, Parrott N
AAPS J. 2017 Nov;19(6):1864-1877.
Predictive Biopharmaceutics and Pharmacokinetics: Modeling and Simulation.
Y. Yang, Y. Zhao, J.Z. Duan, P. Zhao, L. Zhao, X. Zhang
Developing Solid Oral Dosage Forms (Second Edition). Pharmaceutical Theory and Practice, 2017, Pages 399–413
Quantitative Systems Pharmacology Approach for Risk Assessment on Drug-Induced Proarrhythmic Effects with Physiologically Based Pharmacokinetic Model.
Mikiko Nakamura, Fumiya Yoneyama, Akira Hirata, Kazuyuki Fujishima, Ryuta Saito
Journal of Pharmacological and Toxicological Methods. Volume 88, Part 2, November–December 2017, Page 183
Ribociclib Bioavailability Is Not Affected by Gastric pH Changes or Food Intake: In Silico and Clinical Evaluations
Tanay S. Samant, Shyeilla Dhuria, Yasong Lu, Marc Laisney, Shu Yang, Arnaud Grandeury, Martin Mueller-Zsigmondy, Kenichi Umehara, Felix Huth, Michelle Miller, Caroline Germa, Mohamed Elmeliegy.
Clinical Pharmacology & Therapeutics. Volulme 103, Issue 1, January 2018
Software based approaches for drug designing and development: A systematic review on commonly used software and its applications.
Prasad G. Jamkhande, Mahavir H. Ghante a, Balaji R. Ajgunde
Bulletin of Faculty of Pharmacy, Cairo University. Volume 55, Issue 2, December 2017, Pages 203-210
Computer Simulation in Pharmacokinetic and Pharmacodynamic Studies.
Durgawati Patel, Puspendra Kumar
MABB, 2017, Volume 2 Issue 2
Process optimization and in vivo performance of docetaxel loaded PHBV-TPGS therapeutic vesicles: A synergistic approach.
Harsh Vardhan, Pooja Mittal, Sandeep Kumar Reddy Adena, Mansi Upadhyay, Sarita Kumari Yadav, Brahmeshwar Mishra
International Journal of Biological Macromolecules. Available online 27 October 2017
Advances in experimental and mechanistic computational models to understand pulmonary exposure to inhaled drugs.
Per Bäckman, Sumit Arora, William Couet, Ben Forbes, Wilbur de Kruijf, Amrit Paudel
European Journal of Pharmaceutical Sciences. Available online 25 October 2017
Industry's View on Using Quality Control, Biorelevant, and Clinically Relevant Dissolution Tests for Pharmaceutical Development, Registration, and Commercialization.
Haiyan Grady, David Elder, Gregory K. Webster, Yun Mao, Yiqing Lin, Talia Flanagan, James Mann, Andy Blanchard, Michael J. Cohen, Judy Lin, Filippos Kesisoglou, Andre Hermans, Andreas Abend, Limin Zhang, David Curran
Journal of Pharmaceutical Sciences. Volume 107, Issue 1, January 2018, Pages 34-41

2016

Physiologically Based Absorption Modeling for Amorphous Solid Dispersion Formulations.
Mitra A, Zhu W, Kesisoglou F. (2016)
Mol Pharm. Jul 21.
Exploring the Feasibility of Biowaiver Extension of BCS Class III Drugs with Site-Specific Absorption Using Gastrointestinal Simulation Technology.
Sun L, Sun J, He Z. (2016)
Eur J Drug Metab Pharmacokinet. Jul 22.
Justification of drug product dissolution rate and drug substance particle size specifications based on absorption PBPK modelling for lesinurad immediate release tablets.
Pepin XJ, Flanagan TR, Holt DJ, Eidelman A, Treacy D, Rowlings CE. (2016)
Mol Pharm. Jul 20.
Physiologically Based Absorption Modeling to Explore the Impact of Food and Gastric pH Changes on the Pharmacokinetics of Alectinib.
Parrott NJ, Yu LJ, Takano R, Nakamura M, Morcos PN. (2016)
AAPS J. Jul 22.
A Physiologically Based Pharmacokinetic Model for Ganciclovir and Its Prodrug Valganciclovir in Adults and Children.
Lukacova V, Goelzer P, Reddy M, Greig G, Reigner B, Parrott N. (2016)
AAPS J. Jul 22.
The Prediction of the Relative Importance of CYP3A/P-gp to the Non-linear Intestinal Absorption of Drugs by Advanced Compartmental Absorption and Transit (ACAT) Model.
Takano J, Maeda K, Bolger MB, Sugiyama Y. (2016)
Drug Metab Dispos. Aug 18.
Using Physiologically Based Pharmacokinetic (PBPK) Modeling to Evaluate the Impact of Pharmaceutical Excipients on Oral Drug Absorption: Sensitivity Analyses.
Chow EC, Talattof A, Tsakalozou E, Fan J, Zhao L, Zhang X. (2016)
AAPS J. Aug 12.
Characterization of Pharmacokinetics in the Göttingen Minipig with Reference Human Drugs: An In Vitro and In Vivo Approach.
Lignet F, Sherbetijan E, Kratochwil N, Jones R, Suenderhauf C, Otteneder MB, Singer T, Parrott N. (2016)
Pharm Res. Jul 28
Comparing Dog and Human Intestinal Fluids: Implications on Solubility and Biopharmaceutical Risk Assessment.
Walsh PL, Stellabott J, Nofsinger R, Xu W, Levorse D, Galipeau K, Kesisoglou F. (2016)
AAPS PharmSciTech. Sep 6.
Utilizing In Vitro Dissolution-Permeation Chamber for the Quantitative Prediction of pH-Dependent Drug-Drug Interactions with Acid-Reducing Agents: a Comparison with Physiologically Based Pharmacokinetic Modeling.
Zhu AZ, Ho MD, Gemski CK, Chuang BC, Liao M, Xia CQ. (2016)
AAPS J. Sep 6.
An in vitro and in silico study of the impact of engineered surface modifications on drug detachment from model carriers.
Wu S, Zellnitz S, Mercuri A, Salar-Behzadi S, Bresciani M, Fröhlich E. (2016)
Int J Pharm. Aug 31;513(1-2):109-117
In vitro and in silico investigation of electrospun terbinafine hydrochloride-loaded buccal nanofibrous sheets.
Szabó P, Daróczi TB, Tóth G, Zelkó R. (2016)
J Pharm Biomed Anal. Aug 26;131:156-159
IMI - oral biopharmaceutics tools project - evaluation of bottom-up PBPK prediction success part 1: Characterisation of the OrBiTo database of compounds.
Margolskee A, Darwich AS, Pepin X, Pathak SM, Bolger MB, Aarons L, Rostami-Hodjegan A, Angstenberger J, Graf F, Laplanche L, Müller T, Carlert S, Daga P, Murphy D, Tannergren C, Yasin M, Greschat-Schade S, Mück W, Muenster U, van der Mey D, Frank KJ, Lloyd R, Adriaenssen L, Bevernage J, De Zwart L, Swerts D, Tistaert C, Van Den Bergh A, Van Peer A, Beato S, Nguyen-Trung AT, Bennett J, McAllister M, Wong M, Zane P, Ollier C, Vicat P, Kolhmann M, Marker A, Brun P, Mazuir F, Beilles S, Venczel M, Boulenc X, Loos P, Lennernäs H, Abrahamsson B. (2016)
Eur J Pharm Sci. Sep 23.
In vitro–in vivo–in silico simulation studies of anti-tubercular drugs doped with a self nanoemulsifying drug delivery system.
Hussain A, Singh SK, Singh N, Verma PRP. (2016)
RSC Adv. 6:93147
IMI - Oral biopharmaceutics tools project - Evaluation of bottom-up PBPK prediction success part 3: Identifying gaps in system parameters by analysing In Silico performance across different compound classes.
Darwich AS, Margolskee A, Pepin X, Aarons L, Galetin A, Rostami-Hodjegan A, Carlert S, Hammarberg M, Hilgendorf C, Johansson P, Karlsson E, Murphy D, Tannergren C, Thörn H, Yasin M, Mazuir F, Nicolas O, Ramusovic S, Xu C, Pathak SM, Korjamo T, Laru J, Malkki J, Pappinen S, Tuunainen J, Dressman J, Hansmann S, Kostewicz E, He H, Heimbach T, Wu F, Hoft C, Pang Y, Bolger MB, Huehn E, Lukacova V, Mullin JM, Szeto KX, Costales C, Lin J, McAllister M, Modi S, Rotter C, Varma M, Wong M, Mitra A, Bevernage J, Biewenga J, Van Peer A, Lloyd R, Shardlow C, Langguth P, Mishenzon I, Nguyen MA, Brown J, Lennernäs H, Abrahamsson B5. (2016)
Eur J Pharm Sci. Sep 28
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. (2016)
PLoS One Oct 10;11(10)
In vitro and in silico characterisation of Tacrolimus released under biorelevant conditions.
Mercuri A, Wu S, Stranzinger S, Mohr S, Salar-Behzadi S, Bresciani M, Fröhlich E. (2016)
Int J Pharm. Oct 11;515(1-2):271-280
Predicting Exposure After Oral Inhalation of the Selective Glucocorticoid Receptor Modulator, AZD5423, Based on Dose, Deposition Pattern, and Mechanistic Modeling of Pulmonary Disposition.
Bäckman P, Tehler U, Olsson B. (2016)
J Aerosol Med Pulm Drug Deliv. Oct 14
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
Folate-targeted amphiphilic cyclodextrin.siRNA nanoparticles for prostate cancer therapy exhibit PSMA mediated uptake, therapeutic gene silencing in vitro and prolonged circulation in vivo.
Evans JC, Malhotra M, Guo J, O'Shea JP, Hanrahan K, O'Neill A, Landry W, Griffin BT, Darcy R, Watson RW, O'Driscoll CM. (2016)
Nanomedicine. Jul 4
Physiologically Based Absorption Modeling to Design Extended-Release Clinical Products for an Ester Prodrug.
Ding X, Day JS, Sperry DC. (2016)
AAPS J. Jul 12
Evaluation of the GastroPlus™ Advanced Compartmental and Transit (ACAT) Model in Early Discovery.
Gobeau N, Stringer R, De Buck S, Tuntland T, Faller B. (2016)
Pharm Res. Jun 8
Development of In Vitro In Vivo Correlation Models for Clopidogrel Tablets to Describe Administration Under Fasting and Fed Conditions.
Savu SN, Silvestro L, Mircioiu C, Anuta V. (2016)
Farmacia 64(2):302-312
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
Pore blocking: An innovative formulation strategy for the design of alcohol resistant multi-particulate dosage forms.
Schrank S, Jedinger N, Wu S, Piller M, Roblegg E. (2016)
Int J Pharm. 509(1-2):219-28
PBPK modeling and simulation in drug research and development.
Zhuang X, Lu C. (2016)
Acta Pharmaceutica Sinica B June 23
Toward Biopredictive Dissolution for Enteric Coated Dosage Forms.
Al-Gousous J, Amidon GL, Langguth P. (2016)
Mol Pharm. May 10
Comparative human in-vivo study of an immediate release tablet over-encapsulated by gelatin and hydroxypropyl methyl cellulose capsules – impact of dissolution rate on bioequivalence.
Stegemann S, Vishwanath S, Kumar R, Cade D, Lowery M, Hutchison K, Michael Morgen M, Goodwin A, Lee C. (2016)
Capsugel white paper
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
Use of Modeling and Simulation Tools for Understanding the Impact of Formulation on the Absorption of a Low Solubility Compound: Ciprofloxacin.
Martinez M, Mistry B, Lukacova V, Polli J, Hoag S, Dowling T, Kona R, Fahmy R.
AAPS J. Apr 26
The solubility-permeability interplay and oral drug formulation design: Two heads are better than one.
Dahan A, Beig A, Lindley D, Miller JM. (2016)
Adv Drug Deliv Rev. Apr 26
Using Physiologically Based Pharmacokinetic (PBPK) Modelling to Gain Insights into the Effect of Physiological Factors on Oral Absorption in Paediatric Populations.
Villiger A, Stillhart C, Parrott N, Kuentz M. (2016)
AAPS J. Apr 8
In vivo in silico pharmacokinetic simulation studies of carvedilol-loaded nanocapsules using GastroPlus™.
George JK, Singh SK, Verma P. (2016)
Ther Deliv. May;7(5):305-18.
Virtual population pharmacokinetic using physiologically based pharmacokinetic model for evaluating bioequivalence of oral lacidipine formulations in dogs.
Yang B, Wu C, Ji B, Wu M, He Z, Shang L, Sun J. (2016)
Asian J. Pharm. Sci. Mar 21
Simulated rat intestinal fluid improves oral exposure prediction for poorly soluble compounds over a wide dose range.
Berghausen J, Seiler FH, Gobeau N, Faller B. (2016)
4(1):35-53
Development of a Physiologically Based Pharmacokinetic/Pharmacodynamic Model to Predict the Impact of Genetic Polymorphisms on the Pharmacokinetics and Pharmacodynamics Represented by Receptor/Transporter Occupancy of Central Nervous System Drugs.
Alqahtani S, Kaddoumi A. (2016)
Clin Pharmacokinet. Feb 25
In silico modeling of gastrointestinal drug absorption: predictive performance of three physiologically based absorption models.
Sjögren E, Thörn H, Tannergren C. (2016)
Mol Pharm. Feb 29.
Physiologically-Based Pharmacokinetic Modeling in Pediatric Oncology Drug Development.
Rioux N, Waters NJ. (2016)
Drug Metab Dispos. Mar 2
Pharmacokinetic evaluation of cefdinir-loaded floating alginate beads in rabbits using LC–MS/MS.
Praveen R, Singh SK, Verma PRP. (2016)
J. Pharm. Investigation Mar 5
Clinical Micro-Dose Studies to Explore the Human Pharmacokinetics of Four Selective Inhibitors of Human Nav1.7 Voltage-Dependent Sodium Channels.
Jones HM, Butt RP, Webster RW, Gurrell I, Dzygiel P, Flanagan N, Fraier D, Hay T, Iavarone LE, Luckwell J, Pearce H, Phipps A, Segelbacher J, Speed B, Beaumont K. (2016)
Clin Pharmacokinet. Feb 19.
Application of in vitro transmucosal permeability, dose number, and maximum absorbable dose for biopharmaceutics assessment during early drug development for intraoral delivery.
Yang Z, Sotthivirat S, Wu Y, Lalloo A, Nissley B, Manser K, Li H. (2016)
Int J Pharm. Feb 20
LC-ESI-MS/MS estimation of loratadine-loaded Self-nanoemulsifying drug delivery systems in rat plasma: pharmacokinetic evaluation and computer simulations by GastroPlus™.
Verma S, Singh SK. (2016)
J Pharm Biomedical Anal Feb. 8
Estimating Margin of Exposure to Thyroid Peroxidase Inhibitors Using High-throughput In Vitro Data, High-throughput Exposure Modeling, and Physiologically-Based Pharmacokinetic/Pharmacodynamic Modeling.
Leonard JA, Tan YM, Gilbert M, Isaacs K, El-Masri H. (2016)
Toxicol Sci. Feb 10.
Physiologically Based Absorption Modeling to Impact Biopharmaceutics and Formulation Strategies in Drug Development—Industry Case Studies.
Kesisoglou F, Chung J, van Asperen J, Heimbach T. (2016)
J Pharm Sci Jan. 23
Disease specific modeling: simulation of the pharmacokinetics of meloxicam and ibuprofen in disease state vs. healthy conditions.
Almukainzi M, Jamali F, Aghazadeh-Habashi A, Löbenberg R. (2016)
Eur. J. Pharm. Biopharm. Jan. 2
Absorption, distribution, metabolism, excretion, and kinetics of 2,3,3,3-tetrafluoro-2-(heptafluoropropoxy)proprionic acid ammonium salt following a single dose in rat, mouse, and cynomolgus monkey.
Gannon SA, Fasano WJ, Mawn MP, Nabb DL, Buck RC, Buxton LW, Jepson GW, Frame SR. (2015)
Toxicology. Dec 29.
Solidified SNEDDS of loratadine: formulation using hydrophilic and hydrophobic grades of Aerosil®, pharmacokinetic evaluations and in vivo–in silico predictions using GastroPlus™.
Verma S, Singh SK, Verma PRP. (2016)
RSC Adv. 6:3099-3116
Development of a Unified Dissolution and Precipitation Model and Its Use for the Prediction of Oral Drug Absorption.
Jakubiak P, Wagner B, Grimm HP, Petrig-Schaffland J, Schuler F, Alvarez-Sánchez R. (2016)
Mol Pharm. Jan 5.
Methodology of oral formulation selection in the pharmaceutical industry.
Kuentz M, Holm R, Elder DP. (2015)
Eur J Pharm Sci. Dec 11
Establishment of physiologically based pharmacokinetic model of atorvastatin.
Liu J-B, Zhu L-Q, Zhang Y, Yang J-W. (2015)
Chinese J Hospital Pharmacy 35(16):1465-1469
Investigating the effect of autoinduction in cynomolgus monkeys of a novel anticancer MDM2 antagonist, idasanutlin, and relevance to humans.
Glenn KJ, Yu LJ, Reddy MB, Fretland AJ, Parrott N, Hussain S, Palacios M, Vazvaei F, Zhi J, Tuerck D. (2015)
Xenobiotica. Nov 19:1-10.
Preclinical pharmacokinetics of TPN729MA, a novel PDE5 inhibitor, and prediction of its human pharmacokinetics using a PBPK model.
Gao ZW Zhu YT, Yu MM, Zan B, Liu J, Zhang YF, Chen XY, Li XN, Zhong DF. (2015)
Acta Pharmacol Sin. Dec;36(12):1528-36.
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
In vitro anticancer properties and biological evaluation of novel natural alkaloid jerantinine B.
Qazzaz ME, Raja VJ, Lim KH, Kam TS, Lee JB, Gershkovich P, Bradshaw TD. (2015)
Cancer Lett. Oct 26.
Mathematical Model-Based Accelerated Development of Extended-release Metformin Hydrochloride Tablet Formulation.
Chen W, Desai D, Good D, Crison J, Timmins P, Paruchuri S, Wang J, Ha K. (2015)
AAPS PharmSciTech Oct. 19
Mitigation of Adverse Clinical Events of a Narrow Target Therapeutic Index Compound through Modified Release Formulation Design: An In Vitro, In Vivo, In Silico, and Clinical Pharmacokinetic Analysis.
Good DJ, Hartley R, Mathias N, Crison J, Tirucherai G, Timmins P, Hussain M, Haddadin R, Koo O, Nikfar F, Fung NK. (2015)
Mol Pharm. Nov 4

2015

Development of Physiologically Based Pharmacokinetic/Pharmacodynamic Model for Indomethacin Disposition in Pregnancy.
Alqahtani S, Kaddoumi A. (2015)
PLoS One. Oct 2;10(10)
Absorption, Metabolism, Excretion, and the Contribution of Intestinal Metabolism to the Oral Disposition of [14C]Cobimetinib, a MEK Inhibitor, in Humans.
Takahashi RH, Choo EF, Ma S, Wong S, Halladay J, Deng A, Rooney I, Gates M, Hop CE, Khojasteh SC, Dresser M, Musib L. (2015)
Drug Metab Dispos. Oct. 8
Utility of PBPK Absorption Modeling to Guide Modified Release Formulation Development of Gaboxadol, a Highly Soluble Compound with Region-Dependent Absorption.
Kesisoglou F, Balakrishnan A, Manser K. (2015)
J Pharm Sci. Oct 12.
Quantitative aspects of drug permeation across in vitro and in vivo barriers.
Krämer SD. (2015)
Eur J Pharm Sci. Oct 19.
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.
Physicochemical and Pharmacokinetic Characterization of Amorphous Solid Dispersion of Meloxicam with Enhanced Dissolution Property and Storage Stability.
Ochi M, Kimura K, Kanda A, Kawachi T, Matsuda A, Yuminoki K, Hashimoto N. (2015)
AAPS PharmSciTech Oct 5
A canine biorelevant dissolution method for predicting in vivo performance of orally administered sustained release matrix tablets.
Walsh PL, Bothe JR, Bhardwaj S, Hu M, Nofsinger R, Xia B, Persak S, Pennington J, Bak A. (2015)
Drug Dev Ind Pharm. Sep 4:1-9
Effects of Cytochrome P450 3A4 Inhibitors - Ketoconazole and Erythromycin - on Bitopertin Pharmacokinetics and Comparison with Physiologically Based Modelling Predictions.
Boetsch C, Parrott N, Fowler S, Poirier A, Hainzl D, Banken L, Martin-Facklam M, Hofmann C. (2015)
Clin Pharmacokinet. Sep 4.
Development of a Physiologically Based Pharmacokinetic/Pharmacodynamic Model to Identify Mechanisms Contributing to Entacapone Low Bioavailability.
Alqahtani S, Kaddoumi A. (2015)
Biopharm Drug Dispos. Aug 21
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.
PEGylated y-tocotrienol isomer of vitamin E: Synthesis, characterization, in vitro cytotoxicity, and oral bioavailability.
Abu-Fayyad A, Behery F, Sallam A, Alqahtani S, Ebrahim H, El Sayed KA, Kaddoumi A, Sylvester PW, Carroll JL, Cardelli JA, Nazzal S. (2015)
Eur J Pharm Biopharm. Jul 30. pii: S0939-6411(15)00325-2
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. (2015)
Eur J Pharm Biopharm. Jul 26. pii: S0939-6411(15)00303-3
pH-Dependent Solubility and Dissolution Behavior of Carvedilol-Case Example of a Weakly Basic BCS Class II Drug.
Hamed R, Awadallah A, Sunoqrot S, Tarawneh O, Nazzal S, AlBaraghthi T, Al Sayyad J, Abbas A. (2015)
AAPS PharmSciTech. Jul 23
A long-duration dihydroorotate dehydrogenase inhibitor (DSM265) for prevention and treatment of malaria.
Phillips MA, Lotharius J, Marsh K, White J, Dayan A, White KL, Njoroge JW, E Mazouni F, Lao Y, Kokkonda S, Tomchick DR, Deng X, Laird T, Bhatia SN, March S, Ng CL, Fidock DA, Wittlin S, Lafuente-Monasterio M, Benito FJ, Alonso LM, Martinez MS, Jimenez-Diaz MB, Bazaga SF, Angulo-Barturen I, Haselden JN, Louttit J, Cui Y, Sridhar A, Zeeman AM, Kocken C, Sauerwein R, Dechering K, Avery VM, Duffy S, Delves M, Sinden R, Ruecker A, Wickham KS, Rochford R, Gahagen J, Iyer L, Riccio E, Mirsalis J, Bathhurst I, Rueckle T, Ding X, Campo B, Leroy D, Rogers MJ, Rathod PK, Burrows JN, Charman SA. (2015)
Sci Transl Med. Jul 15;7(296):296ra111
Assessment of In Vivo Clinical Product Performance of a Weak Basic Drug by Integration of In Vitro Dissolution Tests and Physiologically Based Absorption Modeling.
Ding X, Gueorguieva I, Wesley JA, Burns LJ, Coutant CA. (2015)
AAPS J. Jul 1.
Acute toxicity prediction in multiple species by leveraging mechanistic ToxCast mitochondrial inhibition data and simulation of oral bioavailability.
Bhhatarai B, Wilson DM, Bartels MJ, Chaudhuri S, Price PS, Carney EW. (2015)
Toxicol Sci. Jul 2.
In vitro-in vivo correlations: general concepts, methodologies and regulatory applications.
González-García I, Mangas-Sanjuán V, Merino-Sanjuán M, Bermejo M. (2015)
Drug Dev Ind Pharm. Jul 2:1-13.
Pharmacometric Models for Characterizing the Pharmacokinetics of Orally Inhaled Drugs.
Borghardt JM, Weber B, Staab A, Kloft C. (2015)
AAPS J. Jul;17(4):853-70
Preclinical pharmacokinetic studies of 3-deazaneplanocin A, a potent epigenetic anticancer agent, and its human pharmacokinetic prediction using GastroPlus™.
Sun F, Lee L, Zhang Z, Wang X, Yu Q, Duan X, Chan E. (2015)
Eur J Pharm Sci. Jun 25.
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
Application of Absorption Modeling in Rational Design of Drug Product Under Quality-by-Design Paradigm.
Kesisoglou F, Mitra A. (2015)
AAPS J. May 22.
Development and validation of in vitro-in vivo correlation (IVIVC) for estradiol transdermal drug delivery systems.
Yang Y, Manda P, Pavurala N, Khan MA, Krishnaiah YS. (2015)
J Control Release. May 13;210:58-66.
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.
Predicting pharmacokinetics of anti-cancer drug, famitinib in human using physiologically based pharmacokinetic model.
Yu MM, Gao ZW, Chen XY, Zhong DF. (2014)
Yao Xue Xue Bao. Dec;49(12):1684-8.
Prediction of pH dependent absorption using in vitro, in silico, and in vivo rat models: Early liability assessment during lead optimization.
Saxena A, Shah D, Padmanabhan S, Gautam SS, Chowan GS, Mandlekar S, Desikan S. (2015)
Eur J Pharm Sci. May 8;76:173-180
In vitro dissolution methodology, mini-Gastrointestinal Simulator (mGIS), predicts better in vivo dissolution of a weak base drug, dasatinib.
Tsume Y, Takeuchi S, Matsui K, Amidon GE, Amidon GL. (2015)
Eur J Pharm Sci. May 12;76:203-212.
Prediction of the pharmacokinetics and tissue distribution of levofloxacin in humans based on an extrapolated PBPK model.
Zhu L, Zhang Y, Yang J, Wang Y, Zhang J, Zhao Y, Dong W. (2015)
Eur J Drug Metab Pharmacokinet. Mar 10.
Pharmacometric Models for Characterizing the Pharmacokinetics of Orally Inhaled Drugs.
Borghardt JM, Weber B, Staab A, Kloft C. (2015)
AAPS J. Apr 7
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
Prospective Predictions of Human Pharmacokinetics for Eighteen Compounds.
Zhang T, Heimbach T, Lin W, Zhang J, He H. (2015)
J Pharm Sci. Feb 17.
Role of Self-Association and Supersaturation in Oral Absorption of a Poorly Soluble Weakly Basic Drug.
Narang AS, Badawy S, Ye Q, Patel D, Vincent M, Raghavan K, Huang Y, Yamniuk A, Vig B, Crison J, Derbin G, Xu Y, Ramirez A, Galella M, Rinaldi FA. (2015)
Pharm Res. Feb 28.
Prediction of Pharmacokinetics and Penetration of Moxifloxacin in Human with Intra-Abdominal Infection Based on Extrapolated PBPK Model.
Zhu L, Yang J, Zhang Y, Wang Y, Zhang J, Zhao Y, Dong W. (2015)
Korean J Physiol Pharmacol. Mar;19(2):99-104.
Development of a Novel Oral Cavity Compartmental Absorption and Transit Model for Sublingual Administration: Illustration with Zolpidem.
Xia B, Yang Z, Zhou H, Lukacova V, Zhu W, Milewski M, Kesisoglou F. (2015)
AAPS J. Feb 26.
Comparison of biorelevant simulated media mimicking the intestinal environment to assess the solubility profiles of poorly soluble drugs.
Prasad D, Gu CH, Kuldipkumar A. (2015)
Pharm Dev Technol. Feb 23:1-7
Interspecies prediction of oral pharmacokinetics of different formulations from dogs to human: physiologically based pharmacokinetic modelling combined with biorelevant dissolution.
Wu C, Kou L, Ma P, Gao L, Li B, Li R, Luo C, Shentu J, Hea Z, Sun J. (2015)
RSC Adv. 5:19844
Utilizing Physiologically Based Pharmacokinetic Modeling to Inform Formulation and Clinical Development for a Compound with pH-Dependent Solubility.
Chung J, Alvarez-Nunez F, Chow V, Daurio D, Davis J, Dodds M, Emery M, Litwiler K, Paccaly A, Peng J, Rock B, Wienkers L, Yang C, Yu Z, Wahlstrom J. (2015)
J. Pharm. Sci. Jan. 15
The potency-insolubility conundrum in pharmaceuticals: Mechanism and solution for hepatitis C protease inhibitors.
Connelly PR, Snyder PW, Zhang Y, McClain B, Quinn BP, Johnston S, Medek A, Tanoury J, Griffith J, Walters WP, Dokou E, Knezic D, Bransford P. (2015)
Biophysical Chem. 196:100-108

2014

Physiologically based pharmacokinetic modelling in drug discovery and development: A pharmaceutical industry perspective.
Jones HM, Chen Y, Gibson C, Heimbach T, Parrott N, Peters SA, Snoeys J, Upreti VV, Zheng M, Hall SD. (2014)
Clin. Pharmacol.
Predicting drug-drug interactions involving multiple mechanisms using physiologically based pharmacokinetic modeling: A case study with ruxolitinib.
Shi JG, Fraczkiewicz G, Williams W, Yeleswaram S. (2014)
Clin. Pharmacol.
Novel Orally Swallowable IntelliCap(®) Device to Quantify Regional Drug Absorption in Human GI Tract Using Diltiazem as Model Drug.
Becker D, Zhang J, Heimbach T, Penland RC, Wanke C, Shimizu J, Kulmatycki K. (2014)
AAPS PharmSciTech. Dec;15(6):1490-7.
Dissolution testing combined with computer simulation technology to evaluate the bioequivalence of domestic amoxicillin capsule.
Pan RX, Gao Y, Chen WL, Li YL, Hu CQ. (2014) Yao Xue Xue Bao.
Aug;49(8):1155-61.
Model-Based Bioequivalence assessment of a commercial Azithromycin Capsule against Pfizer Zithromax® Tablet marketed in Jamaica
Adebayo AS, McFarlane N (2014)
J. Appl. PharmSci. 4(10) 62-68
Biopharmaceutical profiling of new antitumor pyrazole derivatives.
Anuta V, Nitulescu GM, Dinu-Pîrvu CE, Olaru OT. (2014)
Molecules. Oct 13;19(10):16381-401
The potency-insolubility conundrum in pharmaceuticals: Mechanism and solution for hepatitis C protease inhibitors.
Connelly PR, Snyder PW, Zhang Y, McClain B, Quinn BP, Johnston S, Medek A, Tanoury J, Griffith J, Walters WP, Dokou E, Knezic D, Bransford P. (2014)
Biophysical Chem. Sept. 18
Evaluation of a Three Compartment In Vitro Gastrointestinal Simulator Dissolution Apparatus to Predict In Vivo Dissolution.
Takeuchi S, Tsume Y, Amidon GE, Amidon GL. (2014)
J Pharm Sci. 2014 Nov;103(11):3416-22
Elucidation of Arctigenin Pharmacokinetics After Intravenous and Oral Administrations in Rats: Integration of In Vitro and In Vivo Findings via Semi-mechanistic Pharmacokinetic Modeling.
Gao Q, Zhang Y, Wo S, Zuo Z. (2014)
AAPS J. 2014 Nov;16(6):1321-33
Preparation and Evaluation of High Dispersion Stable Nanocrystal Formulation of Poorly Water-Soluble Compounds by Using Povacoat.
Yuminoki K, Seko F, Horii S, Takeuchi H, Teramoto K, Nakada Y, Hashimoto N. (2014)
J Pharm Sci. 2014 Nov;103(11):3772-81
Application of Absorption Modeling to Predict Bioequivalence Outcome of Two Batches of Etoricoxib Tablets.
Mitra A, Kesisoglou F, Dogterom P. (2014)
AAPS PharmSciTech. Sep 3.
Development of nanocrystal formulation of meloxicam with improved dissolution and pharmacokinetic behaviors.
Ochi M, Kawachi T, Toita E, Hashimoto I, Yuminoki K, Onoue S, Hashimoto N. (2014)
Int J Pharm. Aug 17;474(1-2):151-156.
Intestinal transport of TRH analogs through PepT1: the role of in silico and in vitro modeling.
Bagul P, Khomane KS, Kesharwani SS, Pragyan P, Nandekar PP, Meena CL, Bansal AK, Jain R, Tikoo K, Sangamwar AT. (2014)
J Mol. Recognit. 27:609-617
Improvement of trospium-specific absorption models for fasted and fed states in humans.
Cvijic S, Langguth P. (2014)
Biopharm Drug Dispos. 2014 Dec;35(9):553-8
PEGylated cyclodextrins as novel siRNA nanosystems: Correlations between polyethylene glycol length and nanoparticle stability.
Godinho BM, Ogier JR, Quinlan A, Darcy R, Griffin BT, Cryan JF, Caitriona MO. (2014)
Int J Pharm. 473(1-2):105-112
Physiologically Based Absorption Modelling to Predict the Impact of Drug Properties on Pharmacokinetics of Bitopertin.
Parrott N1, Hainzl D, Scheubel E, Krimmer S, Boetsch C, Guerini E, Martin-Facklam M.
AAPS J. 2014 Jun 27
Enhanced Solubility and Oral Bioavailability of γ-Tocotrienol Using a Self-Emulsifying Drug Delivery System (SEDDS).
Alqahtani S1, Alayoubi A, Nazzal S, Sylvester PW, Kaddoumi A.
Lipids. 2014 Jun 17.
Simulation of the In Vivo Exposure to Ibuprofen Based on In Vitro Dissolution Profiles from Solid Dosage Forms.
Popa DE, Lupuliasa D, Stanescu AA, Barca M, Burcea Dragomiroiu GTA, Miron DS, Radulescu FS.
Farmacia 2014 62(3):483
Translational PK/PD modeling for cardiovascular safety assessment of drug candidates: Methods and examples in drug development.
Caruso A, Frances N, Meille C, Greiter-Wilke A, Hillebrecht A, Lavé T.
J Pharmacol Toxicol Methods. 2014 May 28;70(1):73-85.
Pharmacokinetics of Paracetamol in Göttingen Minipigs: In Vivo Studies and Modeling to Elucidate Physiological Determinants of Absorption.
Suenderhauf C, Tuffin G, Lorentsen H, Grimm HP, Flament C, Parrott N.
Pharm Res. 2014 May 3.
Testicular distribution and toxicity of a novel LTA4H inhibitor in rats.
Ward PD, La D
Toxicol Appl Pharmacol. 2014 Jul 1;278(1):26-30.
Modelling the Absorption of Metformin with Patients Post Gastric Bypass Surgery.
Almukainzi M, Lukacova V, Löbenberg R
J Diabetes Metab 2014 5:353
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.
AAPS PharmSciTech. 2014 Apr;15(2):407-16.
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
AAPS PharmSciTech. 2014 Apr;15(2):400-6.
The Biopharmaceutics Classification System: Subclasses for in vivo predictive dissolution (IPD) methodology and IVIVC.
Tsume Y, Mudie DM, Langguth P, Amidon GE, Amidon GL.
Eur J Pharm Sci. 2014 Jan 28. pii: S0928-0987(14)00028-1.
Physiologically based pharmacokinetic modeling of CYP3A4 induction by rifampicin in human: Influence of time between substrate and inducer administration.
Baneyx G, Parrott N, Meille C, Iliadis A, Lave T.
Eur J Pharm Sci. 2014 Feb 12;56C:1-15.
Neuroprotective Potential of Peroxisome Proliferator Activated Receptor-α Agonist in Cognitive Impairment in Parkinson’s Disease: Behavioral, Biochemical, and PBPK Profile
Dedeepya Uppalapati, Nihar R. Das, Rahul P. Gangwal, Mangesh V. Damre, Abhay T. Sangamwar, and Shyam S. Sharma
PPAR Research. Volume 2014 (2014)
Extemporaneously prepared controlled release formulations for accelerating the early phase development of drug candidates.
Thombre AG, Berchielli A, Rogers JF.
Drug Discov Today. 2014 May;19(5):694-700.
Implementing Toxicity Testing in the 21st Century (TT21C): Making safety decisions using toxicity pathways, and progress in a prototype risk assessment.
Adeleye Y, Andersen M, Clewell R, Davies M, Dent M, Edwards S, Fowler P, Malcomber S, Nicol B, Scott A, Scott S, Sun B, Westmoreland C, White A, Zhang Q, Carmichael PL.
Toxicology. 2014 Feb 25. pii: S0300-483X(14)00032-8.
A PPAR-β/δ agonist is neuroprotective and decreases cognitive impairment in a rodent model of Parkinson's disease.
Das NR, Gangwal RP, Damre MV, Sangamwar AT, Sharma SS
Curr Neurovasc Res. 2014 May;11(2):114-24.
Characterization of preclinical in vitro and in vivo ADME properties and prediction of human PK using a physiologically based pharmacokinetic model for YQA-14, a new dopamine D3 receptor antagonist candidate for treatment of drug addiction.
Liu F, Zhuang X, Yang C, Li Z, Xiong S, Zhang Z, Li J, Lu C, Zhang Z.
Biopharm Drug Dispos. 2014 Mar 19.
Physiologically based pharmacokinetic modeling framework for quantitative prediction of an herb-drug interaction.
Brantley SJ, Gufford BT, Dua R1, Fediuk DJ, Graf TN, Scarlett YV, Frederick KS, Fisher MB, Oberlies NH, Paine MF
CPT Pharmacometrics Syst Pharmacol. 2014 Mar 26;3:e107.
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.
Cvijić S, Parojčić J, Langguth P
Eur J Pharm Sci. 2014 Sep 30;61:40-53.
A case study of in silico modelling of ciprofloxacin hydrochloride/metallic compound interactions.
Stojkovic A1, Parojcic J, Djuric Z, Corrigan OI
AAPS PharmSciTech. 2014 Apr;15(2):270-8.

2013

Clinical Pharmacokinetics of Buffered Propranolol Sublingual Tablet (Promptol™)—Application of a New “Physiologically Based” Model to Assess Absorption and Disposition
Yanfeng Wang, Zhijun Wang, Zhong Zuo, Brian Tomlinson, Benjamin T. K. Lee, Michael B. Bolger, Moses S. S. Chow
The AAPS Journal July 2013, Volume 15, Issue 3, pp 787-796
Physiologically Based Pharmacokinetic Modelling to Predict Single- and Multiple-Dose Human Pharmacokinetics of Bitopertin
Neil Parrott, Dominik Hainzl, Daniela Alberati, Carsten Hofmann, Richard Robson, Bruno Boutouyrie, Meret Martin-Facklam
Clinical Pharmacokinetics August 2013, Volume 52, Issue 8, pp 673-683
In vitro characterization of axitinib interactions with human efflux and hepatic uptake transporters: implications for disposition and drug interactions.
Reyner EL, Sevidal S, West MA, Clouser-Roche A, Freiwald S, Fenner K, Ullah M, Lee CA, Smith BJ
Drug Metab Dispos. 2013 Aug;41(8):1575-83.
Compartmental absorption modeling and site of absorption studies to determine feasibility of an extended-release formulation of an HIV-1 attachment inhibitor phosphate ester prodrug.
Brown J, Chien C, Timmins P, Dennis A, Doll W, Sandefer E, Page R, Nettles RE, Zhu L, Grasela D.
J Pharm Sci. 2013 Jun;102(6):1742-51.
Amorphous solid dispersions and nano-crystal technologies for poorly water-soluble drug delivery
Brough C, Williams RO 3rd
Int J Pharm. 2013 Aug 30;453(1):157-66.
Profiling biopharmaceutical deciding properties of absorption of lansoprazole enteric-coated tablets using gastrointestinal simulation technology
Wu C, Sun L, Sun J, Yang Y, Ren C, Ai X, Lian H, He Z
Int J Pharm. 2013 Sep 10;453(2):300-6.
Physiologically based pharmacokinetic and pharmacodynamic modeling of an antagonist (SM-406/AT-406) of multiple inhibitor of apoptosis proteins (IAPs) in a mouse xenograft model of human breast cancer
Tao Zhang, Yanyan Li, Peng Zou, Jing-yu Yu, Donna McEachern, Shaomeng Wang, Duxin Sun
Biopharmaceutics & Drug Disposition Volume 34, Issue 6, pages 348–359, September 2013
A simplified PBPK modeling approach for prediction of pharmacokinetics of four primarily renally excreted and CYP3A metabolized compounds during pregnancy
Xia B, Heimbach T, Gollen R, Nanavati C, He H
AAPS J. 2013 Oct;15(4):1012-24
In vitro-in vivo correlation of efavirenz tablets using GastroPlusR
Honorio Tda S1, Pinto EC, Rocha HV, Esteves VS, dos Santos TC, Castro HC, Rodrigues CR, de Sousa VP, Cabral LM
AAPS PharmSciTech. 2013 Sep;14(3):1244-54.
Incorporation of physiologically based pharmacokinetic modeling in the evaluation of solubility requirements for the salt selection process: a case study using phenytoin
Chiang PC, Wong H
AAPS J. 2013 Oct;15(4):1109-18
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
AAPS PharmSciTech. 2013 Sep;14(3):1255-66
Use of preclinical dog studies and absorption modeling to facilitate late stage formulation bridging for a BCS II drug candidate.
Kesisoglou F
AAPS PharmSciTech. 2014 Feb;15(1):20-28.
Assessing the Risk of pH-Dependent Absorption for New Molecular Entities: A Novel in Vitro Dissolution Test, Physicochemical Analysis, and Risk Assessment Strategy
Mathias NR, Xu Y, Patel D, Grass M, Caldwell B, Jager C, Mullin J, Hansen L, Crison J, Saari A, Gesenberg C, Morrison J, Vig B, Raghavan K
Mol Pharm. 2013 Nov 4;10(11):4063-73.
Investigation of clinical pharmacokinetic variability of an opioid antagonist through physiologically based absorption modeling
Ding X, He M, Kulkarni R, Patel N, Zhang X
J Pharm Sci. 2013 Aug;102(8):2859-74.
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-Hodjegan A, Sjogren E, Tannergren C, Turner DB, Wagner C, Weitschies W, Dressman J
Eur J Pharm Sci. 2013 Sep 21.
Effects of novel cathepsin K inhibitor ONO-5334 on bone resorption markers: a study of four sustained release formulations with different pharmacokinetic patterns
Tanaka M, Hashimoto Y, Sekiya N, Honda N, Deacon S, Yamamoto M
J Bone Miner Metab. 2013 Oct 11.
Single-dose safety, tolerability, and pharmacokinetics of the antibiotic GSK1322322, a novel peptide deformylase inhibitor.
Naderer OJ1, Dumont E, Zhu J, Kurtinecz M, Jones LS
Antimicrob Agents Chemother. 2013 May;57(5):2005-9.
Predicting pharmacokinetic profiles using in silico derived parameters.
Hosea NA1, Jones HM
Mol Pharm. 2013 Apr 1;10(4):1207-15.
In vitro to in vivo extrapolation and physiologically based modeling of cytochrome P450 mediated metabolism in beagle dog gut wall and liver.
Heikkinen AT1, Fowler S, Gray L, Li J, Peng Y, Yadava P, Railkar A, Parrott N
Mol Pharm. 2013 Apr 1;10(4):1388-99
Application of target-mediated drug disposition model to small molecule heat shock protein 90 inhibitors.
Yamazaki S, Shen Z, Jiang Y, Smith BJ, Vicini P.
Drug Metab Dispos. 2013 Jun;41(6):1285-94.

2012

Biowaiver approach for biopharmaceutics classification system class 3 compound metformin hydrochloride using in silico modeling.
Crison JR, Timmins P, Keung A, Upreti VV, Boulton DW, Scheer BJ.
J. Pharm. Sci., 2012, Feb. 14
In Silico Modeling for the Nonlinear Absorption Kinetics of UK-343,664: A P-gp and CYP3A4 Substrate.
Abuasal BS, Bolger MB, Walker DK, Kaddoumi A.
Mol. Pharm., 2012, Feb. 2
Novel physiologically based pharmacokinetic modeling of patupilone for human pharmacokinetic predictions.
Xia B, Heimbach T, Lin T, He H, Wang Y, Tan E.
Cancer Chemotherapy and Pharmacology, 2012, 69(4)
The Use of Modeling Tools to Drive Efficient Oral Product Design.
Mathias NR, Crison J.
AAPS J., 2012, May 30
Developability assessment of clinical drug products with maximum absorbable doses.
Ding X, Rose JP, Van Gelder J.
Int. J. Pharm., 2012, 427(2):260-9
Parameters for pyrethroid insecticide QSAR and PBPK/PD models for human risk assessment.
Knaak JB, Dary CC, Zhang X, Gerlach RW, Tornero-Velez R, Chang DT, Goldsmith R, Blancato JN.
Rev. Environ. Contam. Toxicol., 2012, 219:1-114
Preclinical Assessment of the Absorption and Disposition of the Phosphatidylinositol 3-Kinase/Mammalian Target of Rapamycin Inhibitor GDC-0980 and Prediction of Its Pharmacokinetics and Efficacy in Human.
Salphati L, Pang J, Plise EG, Lee LB, Olivero AG, Prior WW, Sampath D, Wong S, Zhang X.
Drug Metab. Dispos., 2012, 40(9):1785-96
Application of PBPK modeling to predict human intestinal metabolism of CYP3A substrates? An evaluation and case study using GastroPlus?
Heikkinen AT, Baneyx G, Caruso A, Parrott N.
Eur. J. Pharm. Sci., 2012, 47(2):375-86
Developing In Vitro/In Vivo Correlation of Risperidone Immediate Release Tablet.
Saibi Y, Sato H, and Tachiki H.
AAPS PharmSciTech., 2012, June 14
Comparison of in vitro/in vivo release of RisperdalR ConstaR microspheres
Rawata A, Bhardwajb U, Burgess DJ.
Int. J. Pharm., 2012, 434(1):115-21
Selection of oral bioavailability enhancing formulations during drug discovery.
Zheng W, Jain A, Papoutsakis D, Dannenfelser RM, Panicucci R, Garad S.
Drug Devel. Indus. Pharm., 2012, 38(2):235-47
In silico prediction of drug dissolution and absorption with variation in intestinal pH for BCS class II weak acid drugs: ibuprofen and ketoprofen.
Tsume Y, Langguth P, Garcia-Arieta A, Amidon GL.
Biopharm. Drug Dispos., 2012
Circadian Variations in Exsorptive Transport: In Situ Intestinal Perfusion Data and In Vivo Relevance.
Okyar A, Dressler C, Hanafy A, Baktir G, Lemmer B, Spahn-Langguth H.
Chronobiology International, 2012, 29(4):443-453
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.
Pharm. Res., 2012, Aug. 22
Predicting feasibility and characterizing performance of extended-release formulations using physiologically based pharmacokinetic modeling.
Brown J, Crison J, Timmins P.
Therapeutic Del., 2012, 3(9):1047-59
Pharmacokinetics and Pharmacodynamics of Phase II Drug Metabolizing/Antioxidant Enzymes Gene Response by Anti-cancer Agent Sulforaphane in Rat Lymphocytes
Wang H, Khor TO, Yang Q, Huang Y, Wu TY, Saw CL, Lin W, Androulakis IP, Kong AN.
Mol. Pharm., 2012, Aug. 29
Modeling and simulation of the effect of proton pump inhibitors on magnesium homeostasis: part I. oral absorption of magnesium.
Bai JP, Hausman E, Lionberger R, Zhang X.
Mol. Pharm., 2012, Oct. 11
Simulation of the pharmacokinetics of bisoprolol in healthy adults and patients with impaired renal function using whole-body physiologically based pharmacokinetic modeling.
Li GF, Wang K, Chen R, Zhao HR, Yang J, Zheng QS.
Acta Pharmacol Sin., 2012, Oct. 22
Nilotinib preclinical pharmacokinetics and practical application toward clinical projections of oral absorption and systemic availability.
Xia B, Heimbach T, He H, Lin TH.
Biopharm Drug Dispos., 2012, Oct. 24
Case Studies for Practical Food Effect Assessments across BCS/BDDCS Class Compounds using In Silico, In Vitro, and Preclinical In Vivo Data.
Heimbach T, Xia B, Lin TH, He H.
AAPS J., 2012, Nov 10

2011

Utility of Physiologically Based Absorption Modeling in Implementing Quality by Design in Drug Development.
Zhang X, Lionberger RA, Davit BM, Yu LX.
AAPS J., 2011, 13(1):59-71
The Application of Physiologically Based Pharmacokinetic Modelling to Understanding the Clinical Pharmacokinetics of UK-369,003.
Watson KJ, Davis J, Jones HM.
Drug Metab Dispos., 2011, Mar 30
Simulation of human intravenous and oral pharmacokinetics of 21 diverse compounds using physiologically based pharmacokinetic modelling.
Jones HM, Gardner IB, Collard WT, Stanley PJ, Oxley P, Hosea NA, Plowchalk D, Gernhardt S, Lin J, Dickins M, Rahavendran SR, Jones BC, Watson KJ, Pertinez H, Kumar V, Cole S.
Clin Pharmacokinet., 2011, 1;50(5):331-47
Effect of gastric pH on the pharmacokinetics of a BCS Class II compound in dogs: Utilization of an artificial stomach and duodenum dissolution model and GastroPlus? simulations to predict absorption.
Bhattachar SN, Perkins EJ, Tan JS, Burns LJ.
J Pharm Sci., 2011, Jun 16.
Physiological modeling and assessments of regional drug bioavailability of danoprevir to determine whether a controlled release formulation is feasible.
Reddy MB, Connor A, Brennan BJ, Morcos PN, Zhou A, McLawhon P, Fretland A, Evans P, Smith P, Tran JQ.
Biopharm Drug Dispos., 2011, June 9.
Pre-clinical and clinical pharmacokinetics of PF-02413873, a non-steroidal progesterone receptor antagonist.
Bungay PJ, Tweedy S, Howe DC, Gibson KR, Jones HM, Mount NM.
Drug Metab Dispos., 2011, May 4
Application of PBPK modelling in drug discovery and development at Pfizer.
Jones HM, Dickins M, Youdim K, Gosset JR, Attkins NJ, Hay TL, Gurrell IK, Logan YR, Bungay PJ, Jones BC, Gardner IB.
Xenobiotica, 2011, 0(0):1-13
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.
Int J Pharm., 2011, 418(2):151-60
Pharmacokinetics of dietary cancer chemopreventive compound dibenzoylmethane in rats and the impact of nanoemulsion and genetic knockout of Nrf2 on its disposition
Lin, W, Hong JL, Shen G, Wu RT, Wang Y, Huang MT, Newmark HL, Huang Q, Khor TO, Heimbach T, Kong AN.
Biopharm. Drug Dispos., 2011, 32:65-75
Development of a physiologically based model for oseltamivir and simulation of pharmacokinetics in neonates and infants.
Parrott N, Davies B, Hoffmann G, Koerner A, Lave T, Prinssen E, Theogaraj E, Singer T.
Clin. Pharmacokinet., 2011, 50(9):613-23

2010

The biowaivers extension for BCS Class III drugs: the effect of dissolution rate on on the bioequivalence of BCS Class III IR drugs predicted by computer simulation.
Tsume Y, Amidon GL.
Mol Pharm., 2010, 7(4):1235-43
Dissolution modeling of bead formulations and predictions of bioequivalence for a highly soluble, highly permeable drug.
Sperry DC, Thomas SJ, Lobo E.
Mol Pharm., 2010, Aug 12.
A pH-Dilution Method for Estimation of Biorelevant Drug Solubility along the Gastrointestinal Tract: Application to Physiologically Based Pharmacokinetic Modeling.
Gao Y, Carr RA, Spence JK, Wang WW, Turner TM, Lipari JM, Miller JM.
Mol Pharm., 2010, 7(5):1516-26
In Vitro-In Vivo Correlation for Gliclazide Immediate-Release Tablets Based on Mechanistic Absorption Simulation.
Grbic S, Parojcic J, Ibric S, Djuric Z.
AAPS PharmSciTech., 2010, Dec 23
Black tea improves attention and self-reported alertness.
De Bruin EA, Rowson MJ, Van Buren L, Rycroft JA, Owen GN.
Appetite., 2010, Dec 21.
Prediction of Oral Pharmacokinetics of cMet Kinase Inhibitors in Humans: Physiologically Based Pharmacokinetic Model versus Traditional One Compartment Model.
Yamazaki S, Skaptason J, Romero D, Vekich S, Jones HM, Tan W, Wilner KD, Koudriakova T.
Drug Metab. Dispos., 2010, Nov 23

2009

Practical Anticipation of Human Efficacious Doses and Pharmacokinetics Using In Vitro and Preclinical In Vivo Data.
Heimbach T, Lakshminarayana SB, Hu W, He H.
AAPS J., 2009, 11(3):602-14
The use of gastrointestinal intubation studies for controlled release development.
Sutton SC.
Br J Clin Pharmacol., 2009, 68(3):342-54
Simulations of the nonlinear dose dependence for substrates of influx and efflux transporters in the human intestine.
Bolger MB, Lukacova V, Woltosz WS.
AAPS J., 2009, 11(2):353-63
An investigation into the importance of "Very Rapid Dissolution" criteria for drug bioequivalence demonstration using gastrointestinal simulation technology.
Kovacevic I, Parojcic J, Tubic-Grozdanis M, Langguth P.
AAPS J., 2009, 11(2):381-84
Prediction of modified release pharmacokinetics and pharmacodynamics from in vitro, immediate release, and intravenous data.
Lukacova V, Woltosz WS, Bolger MB.
AAPS J., 2009, 11(2):323-34
Role of physiological intestinal water in oral absorption.
Sutton SC.
AAPS J., 2009, 11(2):277-85
Modelling and PBPK simulation in drug discovery.
Jones HM, Gardner IB, Watson KJ.
AAPS J., 2009, 11(1):155-66
Computer simulations using GastroPlus to justify a biowaiver for etoricoxib solid oral drug products.
Okumu A, Dimaso M, Lobenberg R.
Eur J Pharm Biopharm., 2009, 72(1):91-8
Justification of biowaiver for carbamazepine, a low soluble high permeable compound, in solid dosage forms based on IVIVC and gastrointestinal simulation.
Kovacevic I, Parojcic J, Homsek I, Tubic-Grozdanis M, Langguth P.
Mol Pharm., 2009, 6(1):40-7
Predicting pharmacokinetics of drugs using physiologically based modeling - application to food effects.
Parrott N, Lukacova V, Fraczkiewicz G, Bolger MB.
AAPS J., 2009, 11(1):45-53

2008

Understanding the effect of API properties on bioavailability through absorption modeling.
Kesisoglou F, Wu Y.
AAPS J., 2008, (4):516-25
Dynamic dissolution testing to establish In Vitro / In Vivo Correlations for montelukast sodium, a poorly soluble drug.
Okumu A, DiMaso M, Lobenberg R.
Pharm. Res., 2008, 25(12): 2778-85
Physicochemical properties of the nucleoside prodrug R1626 leading to high oral bioavailability.
Brandl M, Wu X, Holper J, Hong L, Jia Z, Birudaraj R, Reddy M, Alfredson T, Tran T, Larrabee S, Hadig X, Sarma K, Washington C, Hill G, Smith DB.
Drug Dev. Ind. Pharm., 2008, 34(7):683-91
Applications of physiologically based absorption models in drug discovery and development.
Parrott N, Lave T.
Mol Pharm., 2008, 5(5):760-75
Physicochemical characterization of five glyburide powders: a BCS based approach to predict oral absorption.
Wei H, Dalton C, Di Maso M, Kanfer I, Lobenberg R.
Eur J Pharm Biopharm., 2008, 69(3):1046-56
Pre-clinical pharmacokinetics of UK-453,061, a novel non-nucleoside reverse transcriptase inhibitor (NNRTI), and use of in silico physiologically based prediction tools to predict the oral pharmacokinetics of UK-453,061 in man.
Allan G, Davis J, Dickins M, Gardner I, Jenkins T, Jones H, Webster R, Westgate H.
Xenobiotica, 2008, 38(6):620-40

Application of gastrointestinal simulation for extensions for biowaivers of highly permeable compounds.
Tubic-Grozdanis M, Bolger MB, and Langguth P.
AAPS J., 2008, 10(1):213-26
A critical evaluation of fasted state simulating gastric fluid (FaSSGF) that contains sodium lauryl sulfate and proposal of a modified recipe.
Aburub A, Risley DS, Mishra D.
Int J Pharm., 2008, 347(1-2):16-22

2007

Prediction of human pharmacokinetics using physiologically based modeling: a retrospective analysis of 26 clinically tested drugs.
De Buck SS, Sinha VK, Fenu LA, Nijsen MJ, Mackie CE, Gilissen RA.
Drug Metab Dispos., 2007, 35(10):1766-80
The prediction of drug metabolism, tissue distribution, and bioavailability of 50 structurally diverse compounds in rat using mechanism-based absorption, distribution, and metabolism prediction tools.
De Buck SS, Sinha VK, Fenu LA, Gilissen RA, Mackie CE, Nijsen MJ.
Drug Metab Dispos., 2007, 35(4):649-59

2006

In silico modeling of nonlinear drug absorption for the P-gp substrate talinolol and of consequences for the resulting pharmacodynamic effect.
Tubic M, Wagner D, Spahn-Langguth H, Bolger MB, Langguth P.
Pharm. Res., 2006, 23(8):1712
Biorelevant dissolution media as a predictive tool for glyburide a class II drug.
Wei H, Loebenberg R.
Eur. J. Pharm. Sci., 2006, 29:45
A strategy for preclinical formulation development using GastroPlus? as pharmacokinetic simulation tool and a statistical screening design applied to a dog study.
Kuentz M, Nick S, Parrott N, Rothlisberger D.
Eur. J. Pharm. Sci., 2006, 27(1):91
Use of a gastro-intestinal model and GastroPlus for the prediction of in vivo performance.
Naylor TA, Connolly PC, Martini LG, Elder DP, Minekus M, Havenaar R, Zeijdner E.
Industrial Pharmacy, 2006, 12:9-12

2005

Application of full physiological models for pharmaceutical drug candidate selection and extrapolation of pharmacokinetics to man.
Parrott N, Jones H, Paquereau N, Lave T.
Basic Clin Pharmacol Toxicol., 2005, 96(3): 193-9
An evaluation of the utility of physiologically based models of pharmacokinetics in early drug discovery.
Parrott N, Paquereau N, Coassolo P, Lave T.
J Pharm Sci., 2005, 94(10): 2327-43

2004

Regional intestinal absorption and biliary excretion of fluvastatin in the rat: possible involvement of mrp2.
Lindahl A, Sjoberg A, Bredberg U, Toreson H, Ungell AL, Lennernas H.
Mol. Pharm., 2004, 1(5):347-56
Development of clinical dosage forms for a poorly water soluble drug I: application of polyethylene glycol-polysorbate 80 solid dispersion carrier system.
Dannenfelser RM, He H, Joshi Y, Bateman S, Serajuddin AT.
J Pharm Sci., 2004, 93(5): 1165-75
Simulation of absorption, metabolism, and bioavailability.
Bolger MB, Agoram B, Fraczkiewicz R, Steere B.
Drug Bioavailability. Estimation of Solubility, Permeability and Bioavailability. In "Drug Bioavailability. Estimation of Solubility, Permeability and Bioavailability, for the Series Methods and Principles in Medicinal Chemistry", ed. Han van de Waterbeemd , published by Wiley Publishers 2002

2003

Composite solubility versus pH profile and its role in intestinal absorption prediction.
Hendriksen BA, Felix MV, Bolger MB.
AAPS PharmSci., 2003, 5(1):E4

2002

Prediction of intestinal absorption: comparative assessment of GastroPlus and IDEA.
Parrott N, Lave T.
Eur J Pharm Sci., 2002, 17(1-2): 51-61
Predicting drug absorption by computational methods.
Bolger MB, Gilman TM, Fraczkiewicz R, Steere B, Woltosz WS.
Predicting drug absorption by computational methods. Cell Culture Models of Biological Barriers: In-vitro test systems for Drug Absorption and Delivery. C. M. Lehr. Saarbrucken, Taylor & Francis, 2002

2001

Predicting the impact of physiological and biochemical processes on oral drug bioavailability.
Agoram B, Woltosz WS, Bolger MB.
Adv Drug Deliv Rev 50 Suppl., 2001, 1: S41-67
SSL

©2004-2024 Northern Science Consulting Inc. All Rights Reserved.