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1

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, Adam S., Margolskee, Alison, Pepin, Xavier, Aarons, Leon, Galetin, Aleksandra, Rostami-Hodjegan, Amin, Carlert, Sara, Hammarberg, Maria, Hilgendorf, Constanze, Johansson, Pernilla, Karlsson,

Journal:

European Journal of Pharmaceutical Sciences

Year:

2016

Language:

english

File:

PDF, 1.38 MB

english, 2016

2

IMI – Oral Biopharmaceutics Tools project – Evaluation of Bottom-up PBPK Prediction Success Part 2: An Introduction to the Simulation Exercise and Overview of Results

Margolskee, Alison, Darwich, Adam S., Pepin, Xavier, Aarons, Leon, Galetin, Aleksandra, Rostami-Hodjegan, Amin, Carlert, Sara, Hammarberg, Maria, Hilgendorf, Constanze, Johansson, Pernilla, Karlsson,

Journal:

European Journal of Pharmaceutical Sciences

Year:

2016

Language:

english

File:

PDF, 1.55 MB

english, 2016

3

Comparison of in-vivo and in-silico methods used for prediction of tissue: plasma partition coefficients in rat

Helen Graham, Mike Walker, Owen Jones, James Yates, Aleksandra Galetin, Leon Aarons

Journal:

Journal of Pharmacy and Pharmacology

Year:

2012

Language:

english

File:

PDF, 644 KB

english, 2012

4

Evaluation of Various Static In Vitro–In Vivo Extrapolation Models for Risk Assessment of the CYP3A Inhibition Potential of an Investigational Drug

Vieira, Md L T, Kirby, B, Ragueneau-Majlessi, I, Galetin, A, Chien, J Y L, Einolf, H J, Fahmi, O A, Fischer, V, Fretland, A, Grime, K, Hall, S D, Higgs, R, Plowchalk, D, Riley, R, Seibert, E, Skordos,

Journal:

Clinical Pharmacology & Therapeutics

Year:

2014

Language:

english

File:

PDF, 891 KB

english, 2014

5

Understanding the Transport Properties of Metabolites: Case Studies and Considerations for Drug Development

Zamek-Gliszczynski, M. J., Chu, X., Polli, J. W., Paine, M. F., Galetin, A.

Journal:

Drug Metabolism and Disposition

Year:

2014

Language:

english

File:

PDF, 806 KB

english, 2014

6

Application of a Physiologically Based Pharmacokinetic Model to Assess Propofol Hepatic and Renal Glucuronidation in Isolation: Utility of In Vitro and In Vivo Data

Gill, K. L., Gertz, M., Houston, J. B., Galetin, A.

Journal:

Drug Metabolism and Disposition

Year:

2013

Language:

english

File:

PDF, 627 KB

english, 2013

7

Hepatocellular Binding of Drugs: Correction for Unbound Fraction in Hepatocyte Incubations Using Microsomal Binding or Drug Lipophilicity Data

Kilford, P. J., Gertz, M., Houston, J. B., Galetin, A.

Journal:

Drug Metabolism and Disposition

Year:

2008

Language:

english

File:

PDF, 161 KB

english, 2008

8

Contribution of Intestinal Cytochrome P450-Mediated Metabolism to Drug-Drug Inhibition and Induction Interactions

Galetin, Aleksandra, Gertz, Michael, Brian Houston, J.

Journal:

Drug Metabolism and Pharmacokinetics

Year:

2010

Language:

english

File:

PDF, 516 KB

english, 2010

9

Deconvolution and IVIVC: Exploring the Role of Rate-Limiting Conditions

Margolskee, Alison, Darwich, Adam S., Galetin, Aleksandra, Rostami-Hodjegan, Amin, Aarons, Leon

Journal:

The AAPS Journal

Year:

2016

Language:

english

File:

PDF, 2.49 MB

english, 2016

10

Novel minimal physiologically-based model for the prediction of passive tubular reabsorption and renal excretion clearance

Scotcher, Daniel, Jones, Christopher, Rostami-Hodjegan, Amin, Galetin, Aleksandra

Journal:

European Journal of Pharmaceutical Sciences

Year:

2016

Language:

english

File:

PDF, 982 KB

english, 2016

11

Systematic review and comparison of national and international guidelines on diverticular disease

Galetin, T., Galetin, A., Vestweber, K.-H., Rink, A. D.

Journal:

International Journal of Colorectal Disease

Year:

2018

Language:

english

File:

PDF, 759 KB

english, 2018

12

Clinical Probes and Endogenous Biomarkers as Substrates for Transporter Drug-Drug Interaction Evaluation: Perspectives From the International Transporter Consortium

Chu, Xiaoyan, Liao, Mingxiang, Shen, Hong, Yoshida, Kenta, Zur, Arik A., Arya, Vikram, Galetin, Aleksandra, Giacomini, Kathleen M., Hanna, Imad, Kusuhara, Hiroyuki, Lai, Yurong, Rodrigues, David, Sugi

Journal:

Clinical Pharmacology & Therapeutics

Year:

2018

Language:

english

File:

PDF, 1.24 MB

english, 2018

13

Mechanistic Models as Framework for Understanding Biomarker Disposition: Prediction of CreatinineâDrug Interactions

Scotcher, Daniel, Arya, Vikram, Yang, Xinning, Zhao, Ping, Zhang, Lei, Huang, ShiewâMei, RostamiâHodjegan, Amin, Galetin, Aleksandra

Journal:

CPT: Pharmacometrics & Systems Pharmacology

Year:

2020

File:

PDF, 1.23 MB

2020

14

Physiologicallyâbased Pharmacokinetic Modelling of Creatinineâdrug Interactions in the Chronic Kidney Disease Population

Takita, Hiroyuki, Scotcher, Daniel, Chinnadurai, Rajkumar, Kalra, Philip A, Galetin, Aleksandra

Journal:

CPT: Pharmacometrics & Systems Pharmacology

Year:

2020

File:

PDF, 25.64 MB

2020

15

P247 - indoxyl sulfate albumin-facilitated transport via renal drug transporter OAT1 â translation from microfluidic in vitro system to healthy and subjects with severe kidney disease

van der Made, Thom, Fedeconstante, Michele, Scotcher, Daniel, Rostami-Hodjegan, Amin, Masereeuw, Rosalinde, Galetin, Aleksandra

Journal:

Drug Metabolism and Pharmacokinetics

Year:

2020

File:

PDF, 48 KB

2020

16

Methodology for development of a physiological model incorporating CYP3A and P-glycoprotein for the prediction of intestinal drug absorption

Raj Badhan, Jeffrey Penny, Aleksandra Galetin, J. Brian Houston

Journal:

Journal of Pharmaceutical Sciences

Year:

2009

Language:

english

File:

PDF, 527 KB

english, 2009

17

Multiple Inhibition Mechanisms and Prediction of Drug–Drug Interactions: Status of Metabolism and Transporter Models as Exemplified by Gemfibrozil–Drug Interactions

Laura K. Hinton, Aleksandra Galetin, J. Brian Houston

Journal:

Pharmaceutical Research

Year:

2008

Language:

english

File:

PDF, 473 KB

english, 2008

18

Relative Importance of Intestinal and Hepatic Glucuronidation—Impact on the Prediction of Drug Clearance

Helen E. Cubitt, J. Brian Houston, Aleksandra Galetin

Journal:

Pharmaceutical Research

Year:

2009

Language:

english

File:

PDF, 265 KB

english, 2009

19

Prediction of in vivo drug–drug interactions from in vitro data: impact of incorporating parallel pathways of drug elimination and inhibitor absorption rate constant

Hayley S. Brown, Kiyomi Ito, Aleksandra Galetin, J. Brian Houston

Journal:

British Journal of Clinical Pharmacology

Year:

2005

Language:

english

File:

PDF, 296 KB

english, 2005

20

Assessment of algorithms for predicting drug–drug interactions via inhibition mechanisms: comparison of dynamic and static models

Eleanor J. Guest, Karen Rowland-Yeo, Amin Rostami-Hodjegan, Geoffrey T. Tucker, J. Brian Houston, Aleksandra Galetin

Journal:

British Journal of Clinical Pharmacology

Year:

2011

Language:

english

File:

PDF, 1.31 MB

english, 2011

21

Serum concentrations of organochlorine compounds during pregnancy and the newborn

N. Roncevic, S. Pavkov, R. Galetin-Smith, T. Vukavic, M. Vojinovic, M. Djordjevic

Journal:

Bulletin of Environmental Contamination and Toxicology

Year:

1987

Language:

english

File:

PDF, 384 KB

english, 1987

22

DDT and PCBs in human milk: Implication for breast feeding infants

R. Galetin-Smith, S. Pavkov, N. Roncevic

Journal:

Bulletin of Environmental Contamination and Toxicology

Year:

1990

Language:

english

File:

PDF, 376 KB

english, 1990

23

Drug–Drug Interaction Potential of Marketed Oncology Drugs:In VitroAssessment of Time-Dependent Cytochrome P450 Inhibition, Reactive Metabolite Formation and Drug–Drug Interaction Prediction

Jane R. Kenny, Sophie Mukadam, Chenghong Zhang, Suzanne Tay, Carol Collins, Aleksandra Galetin, S. Cyrus Khojasteh

Journal:

Pharmaceutical Research

Year:

2012

Language:

english

File:

PDF, 623 KB

english, 2012

24

Analyzing murine electrocardiogram with PhysioToolkit

Thomas Galetin, Marco Weiergräber, Jürgen Hescheler, Toni Schneider

Journal:

Journal of Electrocardiology

Year:

2010

Language:

english

File:

PDF, 260 KB

english, 2010

25

Quinidine and Haloperidol as Modifiers of CYP3A4 Activity: Multisite Kinetic Model Approach

Journal:

Drug Metabolism and Disposition

Year:

2002

Language:

english

File:

PDF, 424 KB

english, 2002

26

Simultaneous Assessment of Uptake and Metabolism in Rat Hepatocytes: A Comprehensive Mechanistic Model

Menochet, K., Kenworthy, K. E., Houston, J. B., Galetin, A.

Journal:

Journal of Pharmacology and Experimental Therapeutics

Year:

2012

Language:

english

File:

PDF, 838 KB

english, 2012

27

Modelling atypical CYP3A4 kinetics: principles and pragmatism

J. Brian Houston, Aleksandra Galetin

Journal:

Archives of Biochemistry and Biophysics

Year:

2005

Language:

english

File:

PDF, 650 KB

english, 2005

28

Acute abdomen due to vaginal impalement

Philipp Lingohr, Thomas Galetin, Karl Peter Rheinwalt

Journal:

International Journal of Gynecology & Obstetrics

Year:

2010

Language:

english

File:

PDF, 78 KB

english, 2010

29

Pharmacokinetics and bioavailability of pentoxifylline in healthy volunteers-a comparative study of three oral formulations

Milena Pokrajac, Branislava Miljković, Dragan Simić, Branka Brzaković, Aleksandra Galetin

Journal:

European Journal of Pharmaceutics and Biopharmaceutics

Year:

1997

Language:

english

File:

PDF, 355 KB

english, 1997

30

Prediction ofIn VivoDrug-Drug Interactions fromIn VitroData

Hayley S. Brown, Aleksandra Galetin, David Hallifax, Prof. J. Brian Houston

Journal:

Clinical Pharmacokinetics

Year:

2006

Language:

english

File:

PDF, 210 KB

english, 2006

31

Intracellular Drug Concentrations and Transporters: Measurement, Modeling, and Implications for the Liver

Chu, X, Korzekwa, K, Elsby, R, Fenner, K, Galetin, A, Lai, Y, Matsson, P, Moss, A, Nagar, S, Rosania, G R, Bai, J P F, Polli, J W, Sugiyama, Y, Brouwer, K L R

Journal:

Clinical Pharmacology & Therapeutics

Year:

2013

Language:

english

File:

PDF, 1.39 MB

english, 2013

32

Prediction of metabolic clearance using fresh human hepatocytes: Comparison with cryopreserved hepatocytes and hepatic microsomes for five benzodiazepines

Hallifax, D., Galetin, A., Houston, J. B.

Journal:

Year:

2008

Language:

english

File:

PDF, 201 KB

english, 2008

33

Single-incision laparoscopic surgery: outcomes from 224 colonic resections performed at a single center using SILS™

Boris Vestweber, Thomas Galetin, Kathrin Lammerting, Claudia Paul…

Journal:

Surgical Endoscopy

Year:

2013

Language:

english

File:

PDF, 285 KB

english, 2013

34

Pharmacoresistant Ca v 2·3 (E-type/R-type) voltage-gated calcium channels influence heart rate dynamics and may contribute to cardiac impulse conduction

Galetin, Thomas, Tevoufouet, Etienne E., Sandmeyer, Jakob, Matthes, Jan, Nguemo, Filomain, Hescheler, Jürgen, Weiergräber, Marco, Schneider, Toni

Journal:

Cell Biochemistry and Function

Year:

2013

Language:

english

File:

PDF, 2.07 MB

english, 2013

35

PBPK models for the prediction of in vivo performance of oral dosage forms

Kostewicz, Edmund S., Aarons, Leon, Bergstrand, Martin, Bolger, Michael B., Galetin, Aleksandra, Hatley, Oliver, Jamei, Masoud, Lloyd, Richard, Pepin, Xavier, Rostami-Hodjegan, Amin, Sjögren, Erik, Ta

Journal:

European Journal of Pharmaceutical Sciences

Year:

2014

Language:

english

File:

PDF, 3.17 MB

english, 2014

36

The Use of ROC Analysis for the Qualitative Prediction of Human Oral Bioavailability from Animal Data

Olivares-Morales, Andrés, Hatley, Oliver J. D., Turner, David, Galetin, Aleksandra, Aarons, Leon, Rostami-Hodjegan, Amin

Journal:

Pharmaceutical Research

Year:

2014

Language:

english

File:

PDF, 659 KB

english, 2014

37

Reduced Physiologically-Based Pharmacokinetic Model of Repaglinide: Impact of OATP1B1 and CYP2C8 Genotype and Source ofIn VitroData on the Prediction of Drug-Drug Interaction Risk

Gertz, Michael, Tsamandouras, Nikolaos, Säll, Carolina, Houston, J. Brian, Galetin, Aleksandra

Journal:

Pharmaceutical Research

Year:

2014

Language:

english

File:

PDF, 1.85 MB

english, 2014

38

Progress Towards Prediction of Human Pharmacokinetic Parameters from In Vitro Technologies

Brian Houston, J., Galetin, Aleksandra

Journal:

Drug Metabolism Reviews

Year:

2003

Language:

english

File:

PDF, 640 KB

english, 2003

39

Malignant melanoma of the ileo-anal pouch anastomosis after restorative proctocolectomy for ulcerative colitis: report of a case

Philipp Lingohr,Thomas Galetin,Hanno Matthaei…

Journal:

European Journal of Medical Research

Year:

2013

Language:

english

File:

PDF, 889 KB

english, 2013

40

ITC Recommendations for Transporter Kinetic Parameter Estimation and Translational Modeling of Transport-Mediated PK and DDIs in Humans

Zamek-Gliszczynski, M J, Lee, C A, Poirier, A, Bentz, J, Chu, X, Ellens, H, Ishikawa, T, Jamei, M, Kalvass, J C, Nagar, S, Pang, K S, Korzekwa, K, Swaan, P W, Taub, M E, Zhao, P, Galetin, A

Journal:

Clinical Pharmacology & Therapeutics

Year:

2013

Language:

english

File:

PDF, 995 KB

english, 2013

41

Hepatic, Intestinal, Renal, and Plasma Hydrolysis of Prodrugs in Human, Cynomolgus Monkey, Dog, and Rat: Implications for In Vitro-In Vivo Extrapolation of Clearance of Prodrugs

Nishimuta, H., Houston, J. B., Galetin, A.

Journal:

Drug Metabolism and Disposition

Year:

2014

Language:

english

File:

PDF, 662 KB

english, 2014

42

Microsomal prediction of in vivo clearance and associated interindividual variability of six benzodiazepines in humans

Rawden, H. C., Carlile, D. J., Tindall, A., Hallifax, D., Galetin, A., Ito, K., Houston, J. B.

Journal:

Year:

2005

Language:

english

File:

PDF, 353 KB

english, 2005

43

PREDICTION OF TIME-DEPENDENT CYP3A4 DRUG-DRUG INTERACTIONS: IMPACT OF ENZYME DEGRADATION, PARALLEL ELIMINATION PATHWAYS, AND INTESTINAL INHIBITION

Journal:

Drug Metabolism and Disposition

Year:

2005

Language:

english

File:

PDF, 417 KB

english, 2005

44

CYP3A4 Substrate Selection and Substitution in the Prediction of Potential Drug-Drug Interactions

Journal:

Journal of Pharmacology and Experimental Therapeutics

Year:

2005

Language:

english

File:

PDF, 366 KB

english, 2005

45

Mechanistic Pharmacokinetic Modeling for the Prediction of Transporter-Mediated Disposition in Humans from Sandwich Culture Human Hepatocyte Data

Jones, H. M., Barton, H. A., Lai, Y., Bi, Y.-a., Kimoto, E., Kempshall, S., Tate, S. C., El-Kattan, A., Houston, J. B., Galetin, A., Fenner, K. S.

Journal:

Drug Metabolism and Disposition

Year:

2012

Language:

english

File:

PDF, 1.43 MB

english, 2012

46

Quantitative ADME Proteomics – CYP and UGT Enzymes in the Beagle Dog Liver and Intestine

Heikkinen, Aki T., Friedlein, Arno, Matondo, Mariette, Hatley, Oliver J. D., Petsalo, Aleksanteri, Juvonen, Risto, Galetin, Aleksandra, Rostami-Hodjegan, Amin, Aebersold, Ruedi, Lamerz, Jens, Dunkley,

Journal:

Pharmaceutical Research

Year:

2015

Language:

english

File:

PDF, 799 KB

english, 2015

47

IC 50 -based approaches as an alternative method for assessment of time-dependent inhibition of CYP3A4

Burt, Howard J., Galetin, Aleksandra, Houston, J. Brian

Journal:

Year:

2010

Language:

english

File:

PDF, 1018 KB

english, 2010

48

Intestinal and Hepatic Metabolic Activity of Five Cytochrome P450 Enzymes: Impact on Prediction of First-Pass Metabolism

Journal:

Journal of Pharmacology and Experimental Therapeutics

Year:

2006

Language:

english

File:

PDF, 391 KB

english, 2006

49

Potential role of intestinal first-pass metabolism in the prediction of drug–drug interactions

Galetin, Aleksandra, Gertz, Michael, Houston, J Brian

Journal:

Expert Opinion on Drug Metabolism & Toxicology

Year:

2008

Language:

english

File:

PDF, 433 KB

english, 2008

50

Prediction of Human Intestinal First-Pass Metabolism of 25 CYP3A Substrates from In Vitro Clearance and Permeability Data

Gertz, M., Harrison, A., Houston, J. B., Galetin, A.

Journal:

Drug Metabolism and Disposition

Year:

2010

Language:

english

File:

PDF, 272 KB

english, 2010