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Simulations Plus Publication Section
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Dissolution modeling of bead formulations and predictions of bioequivalence for a highly soluble, highly permeable drug.
Sperry DC, Thomas SJ, Lobo E. (2010) Mol Pharm, 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. (2010) Mol Pharm, July 26
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. (2010) Mol Pharm., Jun 17
Practical Anticipation of Human Efficacious Doses and Pharmacokinetics Using In Vitro and Preclinical In Vivo Data.
Heimbach T, Lakshminarayana SB, Hu W, He H. (2009) AAPS J., Aug 26.
The use of gastrointestinal intubation studies for controlled release development.
Sutton SC. (2009) Br J Clin Pharmacol. 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. (2009) AAPS J., May 12
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. (2009) AAPS J., May 20
Prediction of modified release pharmacokinetics and pharmacodynamics from in vitro, immediate release, and intravenous data.
Lukacova V, Woltosz WS, Bolger MB. (2009) AAPS J., May 9
Role of physiological intestinal water in oral absorption.
Sutton SC. (2009) AAPS J., May 2
Modelling and PBPK simulation in drug discovery.
Jones HM, Gardner IB, Watson KJ. (2009) AAPS J., Mar 12
Computer simulations using GastroPlus to justify a biowaiver for etoricoxib solid oral drug products.
Okumu A, Dimaso M, Löbenberg R. (2009) Eur J Pharm Biopharm. 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. (2009) Mol Pharm. 6(1):40-7
Predicting pharmacokinetics of drugs using physiologically based modeling - application to food effects.
Parrott N, Lukacova V, Fraczkiewicz G, Bolger MB. (2009) AAPS J., Jan 29
Understanding the effect of API properties on bioavailability through absorption modeling.
Kesisoglou F, Wu Y. (2008) AAPS J. (4):516-25
Dynamic dissolution testing to establish In Vitro / In Vivo Correlations for montelukast sodium, a poorly soluble drug.
Okumu A, DiMaso M, Löbenberg R. (2008) Pharm. Res. 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. (2008) Drug Dev. Ind. Pharm. 34(7):683-91
Applications of physiologically based absorption models in drug discovery and development.
Parrott N, Lave T. (2008) Mol Pharm. 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, Löbenberg R. (2008) Eur J Pharm Biopharm. 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. (2008) Xenobiotica 38(6):620-40
Application of gastrointestinal simulation for extensions for biowaivers of highly permeable compounds.
Tubic-Grozdanis M, Bolger MB, and Langguth P. (2008) AAPS J. 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. (2008) Int J Pharm. 347(1-2):16-22
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. (2007) Drug Metab Dispos. 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. (2007) Drug Metab Dispos. 35(4):649-59
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. (2006) Pharm. Res. 23(8):1712
Biorelevant dissolution media as a predictive tool for glyburide a class II drug.
Wei H, Loebenberg R. (2006) Eur. J. Pharm. Sci. 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. (2006) Eur. J. Pharm. Sci. 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. (2006) Industrial Pharmacy 12:9-12
Application of full physiological models for pharmaceutical drug candidate selection and extrapolation of pharmacokinetics to man.
Parrott N, Jones H, Paquereau N, Lave T. (2005) Basic Clin Pharmacol Toxicol 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. (2005) J Pharm Sci 94(10): 2327-43
Regional intestinal absorption and biliary excretion of fluvastatin in the rat: possible involvement of mrp2.
Lindahl A, Sjöberg A, Bredberg U, Toreson H, Ungell AL, Lennernäs H. (2004) Mol. Pharm. 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. (2004) J Pharm Sci 93(5): 1165-75
Simulation of absorption, metabolism, and bioavailability.
Bolger MB, Agoram B, Fraczkiewicz R, Steere B. (2003) 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
Composite solubility versus pH profile and its role in intestinal absorption prediction.
Hendriksen BA, Felix MV, Bolger MB. (2003) AAPS PharmSci 5(1):E4
Prediction of intestinal absorption: comparative assessment of GastroPlus and IDEA.
Parrott N, Lave T. (2002) Eur J Pharm Sci 17(1-2): 51-61
Predicting drug absorption by computational methods.
Bolger MB, Gilman TM, Fraczkiewicz R, Steere B, Woltosz WS. (2002) 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
Predicting the impact of physiological and biochemical processes on oral drug bioavailability.
Agoram B, Woltosz WS, Bolger MB. (2001) Adv Drug Deliv Rev 50 Suppl 1: S41-67
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