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Mass Transport Analysis of Bicarbonate Buffer: Effect of the CO2-H2CO3 Hydration-Dehydration Kinetics in the Fluid Boundary Layer and the Apparent Effective p Ka Controlling Dissolution of Acids and Bases.

Al-Gousous J, Salehi N, Amidon GE, Ziff RM, Langguth P, Amidon GL.

Mol Pharm. 2019 Jun 3;16(6):2626-2635. doi: 10.1021/acs.molpharmaceut.9b00187. Epub 2019 May 13.


Exploring Bioequivalence of Dexketoprofen Trometamol Drug Products with the Gastrointestinal Simulator (GIS) and Precipitation Pathways Analyses.

Bermejo M, Kuminek G, Al-Gousous J, Ruiz-Picazo A, Tsume Y, Garcia-Arieta A, González-Alvarez I, Hens B, Amidon GE, Rodriguez-Hornedo N, Amidon GL, Mudie D.

Pharmaceutics. 2019 Mar 15;11(3). pii: E122. doi: 10.3390/pharmaceutics11030122.


Mechanistic analysis and experimental verification of bicarbonate-controlled enteric coat dissolution: Potential in vivo implications.

Al-Gousous J, Ruan H, Blechar JA, Sun KX, Salehi N, Langguth P, Job NM, Lipka E, Loebenberg R, Bermejo M, Amidon GE, Amidon GL.

Eur J Pharm Biopharm. 2019 Jun;139:47-58. doi: 10.1016/j.ejpb.2019.03.012. Epub 2019 Mar 11.


Propagation Characteristics of Fasting Duodeno-Jejunal Contractions in Healthy Controls Measured by Clustered Closely-spaced Manometric Sensors.

Baker JR, Dickens JR, Koenigsknecht M, Frances A, Lee AA, Shedden KA, Brasseur JG, Amidon GL, Sun D, Hasler WL.

J Neurogastroenterol Motil. 2019 Jan 31;25(1):100-112. doi: 10.5056/jnm18112.


Linking the Gastrointestinal Behavior of Ibuprofen with the Systemic Exposure between and within Humans-Part 2: Fed State.

Paixão P, Bermejo M, Hens B, Tsume Y, Dickens J, Shedden K, Salehi N, Koenigsknecht MJ, Baker JR, Hasler WL, Lionberger R, Fan J, Wysocki J, Wen B, Lee A, Frances A, Amidon GE, Yu A, Benninghoff G, Löbenberg R, Talattof A, Sun D, Amidon GL.

Mol Pharm. 2018 Dec 3;15(12):5468-5478. doi: 10.1021/acs.molpharmaceut.8b00736. Epub 2018 Nov 12.


Linking the Gastrointestinal Behavior of Ibuprofen with the Systemic Exposure between and within Humans-Part 1: Fasted State Conditions.

Bermejo M, Paixão P, Hens B, Tsume Y, Koenigsknecht MJ, Baker JR, Hasler WL, Lionberger R, Fan J, Dickens J, Shedden K, Wen B, Wysocki J, Löbenberg R, Lee A, Frances A, Amidon GE, Yu A, Salehi N, Talattof A, Benninghoff G, Sun D, Kuminek G, Cavanagh KL, Rodríguez-Hornedo N, Amidon GL.

Mol Pharm. 2018 Dec 3;15(12):5454-5467. doi: 10.1021/acs.molpharmaceut.8b00515. Epub 2018 Nov 12.


Mass Transport Analysis of the Enhanced Buffer Capacity of the Bicarbonate-CO2 Buffer in a Phase-Heterogenous System: Physiological and Pharmaceutical Significance.

Al-Gousous J, Sun KX, McNamara DP, Hens B, Salehi N, Langguth P, Bermejo M, Amidon GE, Amidon GL.

Mol Pharm. 2018 Nov 5;15(11):5291-5301. doi: 10.1021/acs.molpharmaceut.8b00783. Epub 2018 Oct 26.


In Vivo Predictive Dissolution and Simulation Workshop Report: Facilitating the Development of Oral Drug Formulation and the Prediction of Oral Bioperformance.

Tsume Y, Patel S, Fotaki N, Bergstrӧm C, Amidon GL, Brasseur JG, Mudie DM, Sun D, Bermejo M, Gao P, Zhu W, Sperry DC, Vertzoni M, Parrott N, Lionberger R, Kambayashi A, Hermans A, Lu X, Amidon GE.

AAPS J. 2018 Sep 6;20(6):100. doi: 10.1208/s12248-018-0260-3. No abstract available.


Effect of biphenyl hydrolase-like (BPHL) gene disruption on the intestinal stability, permeability and absorption of valacyclovir in wildtype and Bphl knockout mice.

Hu Y, Epling D, Shi J, Song F, Tsume Y, Zhu HJ, Amidon GL, Smith DE.

Biochem Pharmacol. 2018 Oct;156:147-156. doi: 10.1016/j.bcp.2018.08.018. Epub 2018 Aug 17.


Formulation predictive dissolution (fPD) testing to advance oral drug product development: An introduction to the US FDA funded '21st Century BA/BE' project.

Hens B, Sinko PD, Job N, Dean M, Al-Gousous J, Salehi N, Ziff RM, Tsume Y, Bermejo M, Paixão P, Brasseur JG, Yu A, Talattof A, Benninghoff G, Langguth P, Lennernäs H, Hasler WL, Marciani L, Dickens J, Shedden K, Sun D, Amidon GE, Amidon GL.

Int J Pharm. 2018 Sep 5;548(1):120-127. doi: 10.1016/j.ijpharm.2018.06.050. Epub 2018 Jun 23. Review.


Gastric emptying and intestinal appearance of nonabsorbable drugs phenol red and paromomycin in human subjects: A multi-compartment stomach approach.

Paixão P, Bermejo M, Hens B, Tsume Y, Dickens J, Shedden K, Salehi N, Koenigsknecht MJ, Baker JR, Hasler WL, Lionberger R, Fan J, Wysocki J, Wen B, Lee A, Frances A, Amidon GE, Yu A, Benninghoff G, Löbenberg R, Talattof A, Sun D, Amidon GL.

Eur J Pharm Biopharm. 2018 Aug;129:162-174. doi: 10.1016/j.ejpb.2018.05.033. Epub 2018 May 29.


Biopharmaceutical optimization in neglected diseases for paediatric patients by applying the provisional paediatric biopharmaceutical classification system.

Del Moral Sanchez JM, Gonzalez-Alvarez I, Cerda-Revert A, Gonzalez-Alvarez M, Navarro-Ruiz A, Amidon GL, Bermejo M.

Br J Clin Pharmacol. 2018 Oct;84(10):2231-2241. doi: 10.1111/bcp.13650. Epub 2018 Jul 17.


Measuring the Impact of Gastrointestinal Variables on the Systemic Outcome of Two Suspensions of Posaconazole by a PBPK Model.

Hens B, Talattof A, Paixão P, Bermejo M, Tsume Y, Löbenberg R, Amidon GL.

AAPS J. 2018 Mar 29;20(3):57. doi: 10.1208/s12248-018-0217-6.


Pulse Packet Stochastic Model for Gastric Emptying in the Fasted State: A Physiological Approach.

Talattof A, Amidon GL.

Mol Pharm. 2018 Jun 4;15(6):2107-2115. doi: 10.1021/acs.molpharmaceut.7b01077. Epub 2018 May 1.


Evaluation and optimized selection of supersaturating drug delivery systems of posaconazole (BCS class 2b) in the gastrointestinal simulator (GIS): An in vitro-in silico-in vivo approach.

Hens B, Bermejo M, Tsume Y, Gonzalez-Alvarez I, Ruan H, Matsui K, Amidon GE, Cavanagh KL, Kuminek G, Benninghoff G, Fan J, Rodríguez-Hornedo N, Amidon GL.

Eur J Pharm Sci. 2018 Mar 30;115:258-269. doi: 10.1016/j.ejps.2018.01.039.


Improved Protease-Targeting and Biopharmaceutical Properties of Novel Prodrugs of Ganciclovir.

Sun K, Xu H, Hilfinger JL, Lee KD, Provoda CJ, Sabit H, Amidon GL.

Mol Pharm. 2018 Feb 5;15(2):410-419. doi: 10.1021/acs.molpharmaceut.7b00792. Epub 2018 Jan 5.


In Vitro Characterization of the Biomimetic Properties of Poly(dimethylsiloxane) To Simulate Oral Drug Absorption.

Sinko PD, Gidley D, Vallery R, Lamoureux A, Amidon GL, Amidon GE.

Mol Pharm. 2017 Dec 4;14(12):4661-4674. doi: 10.1021/acs.molpharmaceut.7b00798. Epub 2017 Nov 20.


Mechanistic Basis of Cocrystal Dissolution Advantage.

Cao F, Amidon GL, Rodríguez-Hornedo N, Amidon GE.

J Pharm Sci. 2018 Jan;107(1):380-389. doi: 10.1016/j.xphs.2017.09.014. Epub 2017 Oct 6.


Mechanistic Fluid Transport Model to Estimate Gastrointestinal Fluid Volume and Its Dynamic Change Over Time.

Yu A, Jackson T, Tsume Y, Koenigsknecht M, Wysocki J, Marciani L, Amidon GL, Frances A, Baker JR, Hasler W, Wen B, Pai A, Sun D.

AAPS J. 2017 Nov;19(6):1682-1690. doi: 10.1208/s12248-017-0145-x. Epub 2017 Oct 4.


In Vivo Dissolution and Systemic Absorption of Immediate Release Ibuprofen in Human Gastrointestinal Tract under Fed and Fasted Conditions.

Koenigsknecht MJ, Baker JR, Wen B, Frances A, Zhang H, Yu A, Zhao T, Tsume Y, Pai MP, Bleske BE, Zhang X, Lionberger R, Lee A, Amidon GL, Hasler WL, Sun D.

Mol Pharm. 2017 Dec 4;14(12):4295-4304. doi: 10.1021/acs.molpharmaceut.7b00425. Epub 2017 Oct 5.


The Combination of GIS and Biphasic to Better Predict In Vivo Dissolution of BCS Class IIb Drugs, Ketoconazole and Raloxifene.

Tsume Y, Igawa N, Drelich AJ, Amidon GE, Amidon GL.

J Pharm Sci. 2018 Jan;107(1):307-316. doi: 10.1016/j.xphs.2017.09.002. Epub 2017 Sep 15.


Potential Development of Tumor-Targeted Oral Anti-Cancer Prodrugs: Amino Acid and Dipeptide Monoester Prodrugs of Gemcitabine.

Tsume Y, Drelich AJ, Smith DE, Amidon GL.

Molecules. 2017 Aug 10;22(8). pii: E1322. doi: 10.3390/molecules22081322.


Low Buffer Capacity and Alternating Motility along the Human Gastrointestinal Tract: Implications for in Vivo Dissolution and Absorption of Ionizable Drugs.

Hens B, Tsume Y, Bermejo M, Paixao P, Koenigsknecht MJ, Baker JR, Hasler WL, Lionberger R, Fan J, Dickens J, Shedden K, Wen B, Wysocki J, Loebenberg R, Lee A, Frances A, Amidon G, Yu A, Benninghoff G, Salehi N, Talattof A, Sun D, Amidon GL.

Mol Pharm. 2017 Dec 4;14(12):4281-4294. doi: 10.1021/acs.molpharmaceut.7b00426. Epub 2017 Aug 4.


Magnetic Resonance Imaging Quantification of Fasted State Colonic Liquid Pockets in Healthy Humans.

Murray K, Hoad CL, Mudie DM, Wright J, Heissam K, Abrehart N, Pritchard SE, Al Atwah S, Gowland PA, Garnett MC, Amidon GE, Spiller RC, Amidon GL, Marciani L.

Mol Pharm. 2017 Aug 7;14(8):2629-2638. doi: 10.1021/acs.molpharmaceut.7b00095. Epub 2017 Jul 6.


Mechanistic Oral Absorption Modeling and Simulation for Formulation Development and Bioequivalence Evaluation: Report of an FDA Public Workshop.

Zhang X, Duan J, Kesisoglou F, Novakovic J, Amidon GL, Jamei M, Lukacova V, Eissing T, Tsakalozou E, Zhao L, Lionberger R.

CPT Pharmacometrics Syst Pharmacol. 2017 Aug;6(8):492-495. doi: 10.1002/psp4.12204. Epub 2017 Jul 11.


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).

Tsume Y, Matsui K, Searls AL, Takeuchi S, Amidon GE, Sun D, Amidon GL.

Eur J Pharm Sci. 2017 May 1;102:126-139. doi: 10.1016/j.ejps.2017.02.042. Epub 2017 Mar 3.


Utilization of Gastrointestinal Simulator, an in Vivo Predictive Dissolution Methodology, Coupled with Computational Approach To Forecast Oral Absorption of Dipyridamole.

Matsui K, Tsume Y, Takeuchi S, Searls A, Amidon GL.

Mol Pharm. 2017 Apr 3;14(4):1181-1189. doi: 10.1021/acs.molpharmaceut.6b01063. Epub 2017 Mar 3.


In Vivo Predictive Dissolution (IPD) and Biopharmaceutical Modeling and Simulation: Future Use of Modern Approaches and Methodologies in a Regulatory Context.

Lennernäs H, Lindahl A, Van Peer A, Ollier C, Flanagan T, Lionberger R, Nordmark A, Yamashita S, Yu L, Amidon GL, Fischer V, Sjögren E, Zane P, McAllister M, Abrahamsson B.

Mol Pharm. 2017 Apr 3;14(4):1307-1314. doi: 10.1021/acs.molpharmaceut.6b00824. Epub 2017 Mar 1.


Measurement of in vivo Gastrointestinal Release and Dissolution of Three Locally Acting Mesalamine Formulations in Regions of the Human Gastrointestinal Tract.

Yu A, Baker JR, Fioritto AF, Wang Y, Luo R, Li S, Wen B, Bly M, Tsume Y, Koenigsknecht MJ, Zhang X, Lionberger R, Amidon GL, Hasler WL, Sun D.

Mol Pharm. 2017 Feb 6;14(2):345-358. doi: 10.1021/acs.molpharmaceut.6b00641. Epub 2016 Dec 23.


Exploring gastrointestinal variables affecting drug and formulation behavior: Methodologies, challenges and opportunities.

Hens B, Corsetti M, Spiller R, Marciani L, Vanuytsel T, Tack J, Talattof A, Amidon GL, Koziolek M, Weitschies W, Wilson CG, Bennink RJ, Brouwers J, Augustijns P.

Int J Pharm. 2017 Mar 15;519(1-2):79-97. doi: 10.1016/j.ijpharm.2016.11.063. Epub 2016 Nov 30. Review.


Toward Biopredictive Dissolution for Enteric Coated Dosage Forms.

Al-Gousous J, Amidon GL, Langguth P.

Mol Pharm. 2016 Jun 6;13(6):1927-36. doi: 10.1021/acs.molpharmaceut.6b00077. Epub 2016 May 10.


The Evaluation of In Vitro Drug Dissolution of Commercially Available Oral Dosage Forms for Itraconazole in Gastrointestinal Simulator With Biorelevant Media.

Matsui K, Tsume Y, Amidon GE, Amidon GL.

J Pharm Sci. 2016 Sep;105(9):2804-2814. doi: 10.1016/j.xphs.2016.02.020. Epub 2016 Mar 25.


Mechanistic Analysis of Cocrystal Dissolution as a Function of pH and Micellar Solubilization.

Cao F, Amidon GL, Rodriguez-Hornedo N, Amidon GE.

Mol Pharm. 2016 Mar 7;13(3):1030-46. doi: 10.1021/acs.molpharmaceut.5b00862. Epub 2016 Feb 15.


Carrier-Mediated Prodrug Uptake to Improve the Oral Bioavailability of Polar Drugs: An Application to an Oseltamivir Analogue.

Incecayir T, Sun J, Tsume Y, Xu H, Gose T, Nakanishi T, Tamai I, Hilfinger J, Lipka E, Amidon GL.

J Pharm Sci. 2016 Feb;105(2):925-934. doi: 10.1016/j.xphs.2015.11.036.


Gastrointestinal Motility Variation and Implications for Plasma Level Variation: Oral Drug Products.

Talattof A, Price JC, Amidon GL.

Mol Pharm. 2016 Feb 1;13(2):557-67. doi: 10.1021/acs.molpharmaceut.5b00774. Epub 2016 Jan 7.


Substrate-Competitive Activity-Based Profiling of Ester Prodrug Activating Enzymes.

Xu H, Majmudar JD, Davda D, Ghanakota P, Kim KH, Carlson HA, Showalter HD, Martin BR, Amidon GL.

Mol Pharm. 2015 Sep 8;12(9):3399-407. doi: 10.1021/acs.molpharmaceut.5b00414. Epub 2015 Aug 17.


In Vitro Dissolution of Fluconazole and Dipyridamole in Gastrointestinal Simulator (GIS), Predicting in Vivo Dissolution and Drug-Drug Interaction Caused by Acid-Reducing Agents.

Matsui K, Tsume Y, Amidon GE, Amidon GL.

Mol Pharm. 2015 Jul 6;12(7):2418-28. doi: 10.1021/acs.molpharmaceut.5b00135. Epub 2015 May 27.


In Vivo Predictive Dissolution: Comparing the Effect of Bicarbonate and Phosphate Buffer on the Dissolution of Weak Acids and Weak Bases.

Krieg BJ, Taghavi SM, Amidon GL, Amidon GE.

J Pharm Sci. 2015 Sep;104(9):2894-904. doi: 10.1002/jps.24460. Epub 2015 May 15.


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.

Eur J Pharm Sci. 2015 Aug 30;76:203-12. doi: 10.1016/j.ejps.2015.05.013. Epub 2015 May 12.


Intestinal permeability study of minoxidil: assessment of minoxidil as a high permeability reference drug for biopharmaceutics classification.

Ozawa M, Tsume Y, Zur M, Dahan A, Amidon GL.

Mol Pharm. 2015 Jan 5;12(1):204-11. doi: 10.1021/mp500553b. Epub 2014 Dec 9.


Dipeptidyl peptidase IV as a potential target for selective prodrug activation and chemotherapeutic action in cancers.

Dahan A, Wolk O, Yang P, Mittal S, Wu Z, Landowski CP, Amidon GL.

Mol Pharm. 2014 Dec 1;11(12):4385-94. doi: 10.1021/mp500483v. Epub 2014 Nov 13.


Evaluation of a three compartment in vitro gastrointestinal simulator dissolution apparatus to predict in vivo dissolution.

Takeuchi S, Tsume Y, Amidon GE, Amidon GL.

J Pharm Sci. 2014 Nov;103(11):3416-3422. doi: 10.1002/jps.24112. Epub 2014 Sep 22.


Synthesis and characterization of valyloxy methoxy luciferin for the detection of valacyclovirase and peptide transporter.

Walls ZF, Gupta SV, Amidon GL, Lee KD.

Bioorg Med Chem Lett. 2014 Oct 15;24(20):4781-4783. doi: 10.1016/j.bmcl.2014.09.011. Epub 2014 Sep 16.


In vivo predictive dissolution: transport analysis of the CO2 , bicarbonate in vivo buffer system.

Krieg BJ, Taghavi SM, Amidon GL, Amidon GE.

J Pharm Sci. 2014 Nov;103(11):3473-3490. doi: 10.1002/jps.24108. Epub 2014 Sep 11.


Quantification of gastrointestinal liquid volumes and distribution following a 240 mL dose of water in the fasted state.

Mudie DM, Murray K, Hoad CL, Pritchard SE, Garnett MC, Amidon GL, Gowland PA, Spiller RC, Amidon GE, Marciani L.

Mol Pharm. 2014 Sep 2;11(9):3039-47. doi: 10.1021/mp500210c. Epub 2014 Aug 19.


Biowaiver monographs for immediate-release solid oral dosage forms: codeine phosphate.

Dahan A, Wolk O, Zur M, Amidon GL, Abrahamsson B, Cristofoletti R, Groot DW, Kopp S, Langguth P, Polli JE, Shah VP, Dressman JB.

J Pharm Sci. 2014 Jun;103(6):1592-600. doi: 10.1002/jps.23977. Epub 2014 May 1.


The low/high BCS permeability class boundary: physicochemical comparison of metoprolol and labetalol.

Zur M, Gasparini M, Wolk O, Amidon GL, Dahan A.

Mol Pharm. 2014 May 5;11(5):1707-14. doi: 10.1021/mp500152y. Epub 2014 Apr 15.


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 Jun 16;57:152-63. doi: 10.1016/j.ejps.2014.01.009. Epub 2014 Jan 28.


The dipeptide monoester prodrugs of floxuridine and gemcitabine-feasibility of orally administrable nucleoside analogs.

Tsume Y, Borras Bermejo B, Amidon GL.

Pharmaceuticals (Basel). 2014 Jan 27;7(2):169-91. doi: 10.3390/ph7020169.

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