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Part 1- FDAEPA有关GastroPlus应用文献

001  Use of Modeling and Simulation Tools for Understanding the Impact of Formulation on the Absorption of a Low Solubility Compound: Ciprofloxacin. IF=3.819

Martinez M, Mistry B, Lukacova V, Polli J, Hoag S, Dowling T, Kona R, Fahmy R. AAPS J. Apr 26 

002  Estimating Margin of Exposure to Thyroid Peroxidase Inhibitors Using High-throughput In Vitro Data, High-throughput Exposure Modeling, and Physiologically-Based Pharmacokinetic/Pharmacodynamic Modeling.IF=3.854
Leonard JA, Tan YM, Gilbert M, Isaacs K, El-Masri H. (2016) Toxicol Sci. Feb 10.

003  In vitro-in vivo correlation of parenteral risperidone polymeric microspheres. IF=7.71
Shen J, Choi S, Qu W, Wang Y, Burgess DJ. (2015) J Control Release. Sep 28;218:2-12. 

004  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

Part 2-PBPK及吸收模型综述

005  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

006  Use of physiologically relevant biopharmaceutics tools within the pharmaceutical industry and in regulatory sciences: Where are we now and what are the gaps? IF=3.773
Flanagan T, Van Peer A, Lindahl A. (2016) Eur J Pharm Sci. 91:84-90

007  PBPK modeling and simulation in drug research and development.
Zhuang X, Lu C. (2016) Acta Pharmaceutica Sinica B June 23

Estimating Margin of Exposure to Thyroid Peroxidase Inhibitors Using High-throughput In Vitro Data, High-throughput Exposure Modeling, and Physiologically-Based Pharmacokinetic/Pharmacodynamic Modeling. IF=3.854
Leonard JA, Tan YM, Gilbert M, Isaacs K, El-Masri H. (2016) Toxicol Sci. Feb 10.

009  Methodology of oral formulation selection in the pharmaceutical industry.
Kuentz M, Holm R, Elder DP. (2015) Eur J Pharm Sci. Dec 11

010  Physiologically Based Pharmacokinetic (PBPK) Modeling and Simulation Approaches: A systematic review of published models, applications and model verification.  IF=3.25
Sager JE, Yu J, Raguenau-Majlessi I, Isoherranen N. (2015) Drug Metab Dispos. Aug 21.

Part 3-PBPK模型应用于PK曲线预测

011Clinical 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.

012  LC-ESI-MS/MS estimation of loratadine-loaded Self-nanoemulsifying drug delivery systems in rat plasma: pharmacokinetic evaluation and computer simulations by GastroPlus™.  IF=2.979
Verma S, Singh SK. (2016) J Pharm Biomedical Anal Feb. 8

013  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.  IF=3.621
Gannon SA, Fasano WJ, Mawn MP, Nabb DL, Buck RC, Buxton LW, Jepson GW, Frame SR. (2015) Toxicology. Dec 29.

014  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

015  Investigating the effect of autoinduction in cynomolgus monkeys of a novel anticancer MDM2 antagonist, idasanutlin, and relevance to humans.  IF=2.199
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.

016  Preclinical pharmacokinetics of TPN729MA, a novel PDE5 inhibitor, and prediction of its human pharmacokinetics using a PBPK model.  IF=2.912
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.

017  Investigating the effect of autoinduction in cynomolgus monkeys of a novel anticancer MDM2 antagonist, idasanutlin, and relevance to humans.  IF=2.20

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.

018 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.

019  Absorption, Metabolism, Excretion, and the Contribution of Intestinal Metabolism to the Oral Disposition of [14C]Cobimetinib, a MEK Inhibitor, in Humans.  IF=3.25
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

020  Quantitative aspects of drug permeation across in vitro and in vivo barriers.  IF=3.35
Krämer SD. (2015) Eur J Pharm Sci. Oct 19.

Part 4-口服吸收,制剂处方设计及优化方面应用

021  Pore blocking: An innovative formulation strategy for the design of alcohol resistant multi-particulate dosage forms. IF=3.994
Schrank S, Jedinger N, Wu S, Piller M, Roblegg E. (2016) Int J Pharm. 509(1-2):219-28

022  Toward Biopredictive Dissolution for Enteric Coated Dosage Forms. IF=4.342
Al-Gousous J, Amidon GL, Langguth P. (2016) Mol Pharm. May 10

023  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

024  In silico modeling of gastrointestinal drug absorption: predictive performance of three physiologically based absorption models.  IF=4.342
Sjögren E, Thörn H, Tannergren C. (2016) Mol Pharm. Feb 29.

025  Application of in vitro transmucosal permeability, dose number, and maximum absorbable dose for biopharmaceutics assessment during early drug development for intraoral delivery.  IF=3.994
Yang Z, Sotthivirat S, Wu Y, Lalloo A, Nissley B, Manser K, Li H. (2016) Int J Pharm. Feb 20

026  Physiologically Based Absorption Modeling to Impact Biopharmaceutics and Formulation Strategies in Drug Development—Industry Case Studies.  IF=2.59
Kesisoglou F, Chung J, van Asperen J, Heimbach T. (2016) J Pharm Sci Jan. 23

027  Solidified SNEDDS of loratadine: formulation using hydrophilic and hydrophobic grades of Aerosil®, pharmacokinetic evaluations and in vivo–in silico predictions using GastroPlus™.  IF=3.84
Verma S, Singh SK, Verma PRP. (2016) RSC Adv. 6:3099-3116

028  Development of a Unified Dissolution and Precipitation Model and Its Use for the Prediction of Oral Drug Absorption.  IF=4.384
Jakubiak P, Wagner B, Grimm HP, Petrig-Schaffland J, Schuler F, Alvarez-Sánchez R. (2016) Mol Pharm. Jan 5.

029  Mathematical Model-Based Accelerated Development of Extended-release Metformin Hydrochloride Tablet Formulation.  IF=1.64
Chen W, Desai D, Good D, Crison J, Timmins P, Paruchuri S, Wang J, Ha K. (2015) AAPS PharmSciTech Oct. 19

030  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.  IF=4.38

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

031  Utility of PBPK Absorption Modeling to Guide Modified Release Formulation Development of Gaboxadol, a Highly Soluble Compound with Region-Dependent Absorption.  IF=3.35
Kesisoglou F, Balakrishnan A, Manser K. (2015) J Pharm Sci. Oct 12.

032  Physicochemical and Pharmacokinetic Characterization of Amorphous Solid Dispersion of Meloxicam with Enhanced Dissolution Property and Storage Stability.   IF=1.64
Ochi M, Kimura K, Kanda A, Kawachi T, Matsuda A, Yuminoki K, Hashimoto N. (2015) AAPS PharmSciTech Oct 5

033  A canine biorelevant dissolution method for predicting in vivo performance of orally administered sustained release matrix tablets.   IF=2.10
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

Part 5-制剂体内外相关性及生物等效性考察

034  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

035  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

036  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.

037  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

038  Comparison of Deconvolution-Based and Absorption Modeling IVIVC for Extended Release Formulations of a BCS III Drug Development Candidate.   IF=3.80
Kesisoglou F, Xia B, Agrawal NG. (2015) AAPS J. Aug 20.

Part 6-PK-PD结合模型

039  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

040  Development of Physiologically Based Pharmacokinetic/Pharmacodynamic Model for Indomethacin Disposition in Pregnancy.   IF=3.23

Alqahtani S, Kaddoumi A. (2015) PLoS One. Oct 2;10(10)

041  Development of a Physiologically Based Pharmacokinetic/Pharmacodynamic Model to Identify Mechanisms Contributing to Entacapone Low Bioavailability.   IF=2.34
Alqahtani S, Kaddoumi A. (2015) Biopharm Drug Dispos. Aug 21

Part 7-特殊人群的PK预测

042  Using Physiologically Based Pharmacokinetic (PBPK) Modelling to Gain Insights into the Effect of Physiological Factors on Oral Absorption in Paediatric Populations.   IF=3.819
Villiger A, Stillhart C, Parrott N, Kuentz M. (2016) AAPS J. Apr 8

043  Physiologically-Based Pharmacokinetic Modeling in Pediatric Oncology Drug Development.
Rioux N, Waters NJ. (2016) Drug Metab Dispos. Mar 2

044  Disease specific modeling: simulation of the pharmacokinetics of meloxicam and ibuprofen in disease state vs. healthy conditions.   IF=3.383
Almukainzi M, Jamali F, Aghazadeh-Habashi A, Löbenberg R. (2016) Eur. J. Pharm. Biopharm. Jan. 2

Part 8-其他方面的应用-食物效应,DDI,肝肠循环等

045  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

046  Deciphering nifedipine in vivo delivery from modified release dosage forms: Identification of food effect.   IF=.912
Ilic M, Kovacevic I, Parojcic J. (2015) Acta Pharm. 65:427 

047  Effects of Cytochrome P450 3A4 Inhibitors - Ketoconazole and Erythromycin - on Bitopertin Pharmacokinetics and Comparison with Physiologically Based Modelling Predictions.    IF=5.05
Boetsch C, Parrott N, Fowler S, Poirier A, Hainzl D, Banken L, Martin-Facklam M, Hofmann C. (2015) Clin Pharmacokinet. Sep 4.