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Pithavala, YK et al.
Feb 2012
Effect of ketoconazole on the pharmacokinetics of axitinib in healthy volunteers.
Investigational New Drugs
30, 273-281, February 2012
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Plowchalk DR & Rowland-Yeo K
Jan 2012
Prediction of drug clearance in a smoking population: modeling the impact of variable cigarette consumption on the induction of CYP1A2.
European Journal of Clinical Pharmacology
E-Publication Ahead Of Print, 2012
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Bouzom F et al.
Jan 2012
Physiologically Based PharmacoKinetic (PBPK) modelling tools: how to fit with our needs?
Biopharmaceutics & Drug Disposition
E-Publication Ahead Of Print, 2012
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Chen Y et al.
Jan 2012
Application of IVIVE and PBPK modelling in prospective prediction of clinical pharmacokinetics: strategy and approach during the drug discovery phase with four case studies.
Biopharmaceutics and Drug Disposition
E-Publication Ahead Of Print, 2012
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Boulenc X et al.
Jan 2012
Effects of omeprazole and genetic polymorphism of CYP2C19 on the clopidogrel active metabolite.
Drug Metabolism & Disposition
40, 187-197, January 2012
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Harrison A et al.
Jan 2012
Case studies addressing human pharmacokinetic uncertainty using a combination of pharmacokinetic simulation and alternative first in human paradigms.
Xenobiotica
42, 57-74, January 2012
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Shaffer CL et al.
Dec 2011
Using Simcyp to project human oral pharmacokinetic variability in early drug research to mitigate mechanism-based adverse events.
Biopharmaceutics & Drug Disposition
E-Publication Ahead Of Print, 2011
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Jayaraman R et al.
Dec 2011
Preclinical metabolism and disposition of SB939 (pracinostat), an orally active histone deacetylase inhibitor, and prediction of human pharmacokinetics.
Drug Metabolism & Disposition
39, 2219-2232, December 2011
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Chappell JC et al.
Dec 2011
Evaluation of methods for achieving stable INR in healthy subjects during a multiple-dose warfarin study.
European Journal of Clinical Pharmacology
E-Publication Ahead Of Print, 2011
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Tortorici MA et al.
Dec 2011
Influence of mild and moderate hepatic impairment on axitinib pharmacokinetics.
Investigational New Drugs
29, 1370-1380, December 2011
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Damle B
Nov 2011
Pharmacokinetics of voriconazole administered concomitantly with fluconazole and population-based simulation for sequential use.
Antimicrobial Agents & Chemotherapy
55, 5172-7177, November 2011
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Ogilvie BW et al.
Nov 2011
The proton pump inhibitor, omeprazole, but not lansoprazole or pantoprazole, is a metabolism-dependent inhibitor of CYP2C19: implications for coadministration with clopidogrel.
Drug Metabolism & Disposition
39, 2020-2033, November 2011
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Chen Y et al.
Nov 2011
Determination of time-dependent inactivation of CYP3A4 in cryopreserved human hepatocyte and assessment of human drug-drug interactions.
Drug Metabolism and Disposition
39, 2085-2092, November 2011
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Friedman EJ et al.
Nov 2011
Effect of different durations and formulations of diltiazem on the single-dose pharmacokinetics of midazolam: how long do we go?
Journal of Clinical Pharmacology
51, 1561-1570, November 2011
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Berry LM et al.
Nov 2011
Species differences in distribution and prediction of human Vss from preclinical data.
Drug Metabolism and Disposition
39, 2103-2116, November 2011
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Jornil J et al.
Oct 2011
Risk assessment of accidental nortriptyline poisoning: The importance of cytochrome P450 for nortriptyline elimination investigated using a population-based pharmacokinetic simulator.
European Journal of Pharmaceutical Sciences
44, 265-272, October 2011
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Malhotra B et al.
Aug 2011
Effects of the moderate CYP3A4 inhibitor, fluconazole, on the pharmacokinetics of fesoterodine in healthy subjects.
British Journal of Clinical Pharmacology
72 , 263-269, August 2011
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Wattanachai N et al.
Aug 2011
In vitro-in vivo extrapolation of CYP2C8-catalyzed paclitaxel 6a-hydroxylation: effects of albumin on in vitro kinetic parameters and assessment of interindividual variability in predicted clearance.
European Journal of Clinical Pharmacology
67, 815-824, August 2011
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Xu Y et al.
Jul 2011
Simulation of clinical drug-drug interactions from hepatocyte CYP3A4 induction data and its potential utility in trial designs.
Drug Metabolism & Disposition
39, 1139-1148, July 2011
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Sinha VK et al.
May 2011
Towards a better prediction of peak concentration, volume of distribution and half-life after oral drug administration in man, using allometry.
Clinical Pharmacokinetics
50, 307-318, May 2011
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Miyagi SJ & Collier AC
May 2011
The development of UGT1A1 and 1A6 in the pediatric liver.
Drug Metabolism & Disposition
39, 912-919, May 2011
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Rekic D et al.
Apr 2011
In silico prediction of efavirenz and rifampicin drug-drug interaction considering weight and CYP2B6 phenotype.
British Journal of Clinical Pharmacology
71, 536-543, April 2011
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Judson RS et al.
Apr 2011
Estimating toxicity-related biological pathway altering doses for high-throughput chemical risk assessment.
Chem Res Toxicol
24, 451-462, April 2011
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Chen Y et al.
Mar 2011
Utility of intersystem extrapolation factors in early reaction phenotyping and the quantitative extrapolation of human liver microsomal intrinsic clearance using recombinant cytochromes P450.
Drug Metabolism and Disposition
39, 373-382, March 2011
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Nettleton DO & Einolf HJ
Feb 2011
Assessment of cytochrome p450 enzyme inhibition and inactivation in drug discovery and development.
Current Topics in Medicinal Chemistry
11, 382-403, February 2011
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Gandelman K et al.
Feb 2011
Unexpected effect of rifampin on the pharmacokinetics of linezolid: in silico and in vitro approaches to explain its mechanism.
Journal of Clinical Pharmacology
51, 229-236, February 2011
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Idkaidek N & Arafat T
Jan 2011
Effect of microgravity on the pharmacokinetics of ibuprofen in humans.
J Clin Pharmacol
51, 1685-1689, December 2011
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Guest EJ et al.
Jan 2011
Assessment of algorithms for predicting drug-drug interactions via inhibition mechanisms: comparison of dynamic and static models.
British Journal of Clinical Pharmacology
71, 72-87, January 2011
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Guest EJ et al.
Dec 2010
Critique of the two-fold measure of prediction success for ratios:
application for the assessment of drug-drug interactions.
Drug Metabolism & Disposition
39, 170-173, December 2010
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Zhao P et al.
Dec 2010
Applications of physiologically based pharmacokinetic (PBPK) modeling and simulation during regulatory review.
Clinical Pharmacology & Therapeutics
89, 259-267, December 2010
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Motta P et al.
Dec 2010
Casopitant: in-vitro data and SimcypTM simulation to predict in-vivo metabolic interactions involving Cytochrome P450 3A4.
Drug Metabolism & Disposition
39, 363-372, December 2010
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Sinha VK et al.
Nov 2010
Prediction of oral absorption and drug drug interaction potential using physiologically based pharmacokinetic (PBPK) modeling.
PSWC / AAPS Meeting
New Orleans, USA, 13th-19th November 2010
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Jin JY et al.
Nov 2010
Use of the Simcyp Population-Based ADME Simulator in early drug development: examples.
PSWC / AAPS Meeting
New Orleans, USA, 13th-19th November 2010
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Venkatakrishnan K
Nov 2010
A quantitative framework and strategies for management and evaluation of metabolic drug-drug interactions in oncology drug development: new molecular entities as object drugs.
Clinical Pharmacokinetics
49, 703-727, November 2010
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Rotroff DM et al.
Oct 2010
Incorporating human dosimetry and exposure into high-throughput In vitro toxicity screening.
Toxicological Sciences
117, 348-358, October 2010
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Shaffer CL et al.
Sep 2010
Using Simcyp® to project human oral pharmacokinetic variability in lead development to mitigate mechanism-based adverse events in the clinic.
9th International ISSX Meeting
Istanbul, Turkey, September 4th-8th 2010
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Wang YH
Jul 2010
Confidence assessment of predicting clinical drug interactions of mechanism-based CYP3A inhibitors using Simcyp time-based approach and a static mathematic model.
Drug Metabolism & Disposition
38, 1094-1104, July 2010
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Foti RS et al.
Jun 2010
Selection of alternative CYP3A4 probe substrates for clinical drug interaction studies using in vitro data and in vivo simulation.
Drug Metabolism and Disposition
38, 981-987, June 2010
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Polasek TM et al.
Mar 2010
In vitro-in vivo extrapolation of zolpidem as a perpetrator of metabolic interactions involving CYP3A.
European Journal of Clinical Pharmacology
66, 275-283, March 2010
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Jornil J et al.
Mar 2010
Identification of cytochrome P450 isoforms involved in the metabolism of paroxetine and estimation of their importance for human paroxetine metabolism using a population-based simulator.
Drug Metabolism & Disposition
38, 376-385, March 2010
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Berry LM et al.
Jan 2010
Prediction of V(ss) from in vitro tissue binding studies.
Drug Metabolism & Disposition
38, 115-121, January 2010
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Xu L et al.
Dec 2009
Prediction of human drug and drug interactions from time-dependent inactivation of CYP3A4 in primary hepatocytes using a population-based simulator.
Drug Metabolism & Disposition
37, 2330-2339, December 2009
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Caldwell GW et al.
Nov 2009
ADME optimization and toxicity assessment in early- and late-phase drug discovery.
Current Topics in Medicinal Chemistry
9, 965-980, 2009
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Wong H et al.
Nov 2009
Preclinical assessment of the absorption, distribution, metabolism and excretion of GDC-0449 (2-chloro-N-(4-chloro-3-(pyridin-2-yl)phenyl)-4-(methylsulfonyl)benzamide), an orally bioavailable systemic Hedgehog signalling pathway inhibitor.
Xenobiotica
39, 850-861, November 2009
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Polasek TM et al.
Oct 2009
Assessment of inter-individual variability in predicted phenytoin clearance.
European Journal of Clinical Pharmacology
65, 1203-1210, December 2009
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Espié P et al.
Oct 2009
Physiologically based pharmacokinetics (PBPK).
Drug Metabolism Reviews
41, 391-407, 2009
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De Groot MJ et al.
Oct 2009
Understanding CYP2D6 interactions.
Drug Discovery Today
14, 964-972, October 2009
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Foti RS et al.
Sep 2009
In vitro inhibition of multiple cytochrome P450 isoforms by xanthone derivatives from mangosteen extract.
Drug Metabolism & Disposition
37, 1848-1855, September 2009
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Fahmi OA et al.
Aug 2009
Comparison of different algorithms for predicting clinical drug-drug interactions, based on the use of CYP3A4 in vitro data: predictions of compounds as precipitants of interaction.
Drug Metabolism & Disposition
37, 1658-1666, August 2009
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Gibson CR et al.
Aug 2009
Prediction of Phase I single-dose pharmacokinetics using recombinant cytochromes P450 and physiologically based modelling.
Xenobiotica
39, 637-648, September 2009
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Grimm SW et al.
Jul 2009
The conduct of in vitro studies to address time-dependent inhibition of drug-metabolizing enzymes: a perspective of the Pharmaceutical Research and Manufacturers of America (PhRMA).
Drug Metabolism & Disposition
37, 1355-1370, July 2009
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Chu V et al.
Jul 2009
In vitro and in vivo induction of cytochrome p450: a survey of the current practices and recommendations: a Pharmaceutical Research and Manufacturers of America (PhRMA) perspective.
Drug Metabolism & Disposition
37, 1339-1354, July 2009
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Hyland R et al.
Apr 2009
In vitro and in vivo glucuronidation of midazolam in humans.
British Journal of Clinical Pharmacology
67, 445-454, April 2009
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Emoto C et al.
Mar 2009
Utilization of estimated physicochemical properties as an integrated part of predicting hepatic clearance in the early drug-discovery stage: impact of plasma and microsomal binding.
Xenobiotica
39, 227-235, March 2009
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Summerfield S & Jeffrey P
Mar 2009
Discovery DMPK: changing paradigms in the eighties, nineties and noughties.
Expert Opinion on Drug Discovery
4, 207-218, 2009
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Thelingwani RS et al.
Mar 2009
In vitro and in silico identification and characterisation of thiabendazole as a mechanism-based inhibitor of CYP1A2 and simulation of possible pharmacokinetic drug-drug interactions.
Drug Metabolism & Disposition
37, 1286-1294, June 2009
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Badwan A et al.
Mar 2009
Enhancement of oral bioavailability of insulin in humans.
Neuro Endocrinology Letters
30, 74-78, March 2009
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Zhao P et al.
Feb 2009
Quantitative evaluation of pharmacokinetic inhibition of CYP3A substrates by ketoconazole: a simulation study.
Journal of Clinical Pharmacology
49, 351-359, March 2009
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Grime KH et al.
Feb 2009
Mechanism-based inhibition of cytochrome P450 enzymes: an evaluation of early decision making in vitro approaches and drug-drug interaction prediction methods.
European Journal of Pharmaceutical Sciences
36, 175-191, February 2009
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Bouzom F & Walther B
Dec 2008
Pharmacokinetic predictions in children by using the physiologically based pharmacokinetic modelling.
Fundamentals of Clinical Pharmacology
22, 579-587, December 2008
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Hyland R et al.
Oct 2008
Maraviroc: in vitro assessment of drug-drug interaction potential.
British Journal of Clinical Pharmacology
66, 498-507, October 2008
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Westerhoff HV et al.
Sep 2008
Integrating systems approaches into pharmaceutical sciences.
European Journal of Pharmaceutical Sciences
35, 1-4, September 2008
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Karalis V et al.
Aug 2008
Bioavailability and bioequivalence: focus on physiological factors and variability.
Pharmaceutical Research
25, 1956-1962, August 2008
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Fowler S & Zhang H
Jun 2008
In vitro evaluation of reversible and irreversible cytochrome P450 inhibition: current status on methodologies and their utility for predicting drug-drug interactions.
The AAPS Journal
10, 410-424, June 2008
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McGinnity DF et al.
Jun 2008
Integrated in vitro analysis for the in vivo prediction of cytochrome P450-mediated drug-drug interactions.
Drug Metabolism & Disposition
36, 1126-1134, June 2008
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Youdim KA et al.
May 2008
Application of CYP3A4 in vitro data to predict clinical drug-drug interactions: predictions of compounds as objects of interaction.
British Journal of Clinical Pharmacology
65, 680-692, May 2008
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Dong JQ et al.
Mar 2008
Applications of computer-aided pharmacokinetic and pharmacodynamic methods from drug discovery through registration.
Current Computer-Aided Drug Design
4, 54-66, March 2008
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Foti RS et al.
Mar 2008
Metabolism and related human risk factors for hepatic damage by usnic acid containing nutritional supplements.
Xenobiotica
38, 264-280, March 2008
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Rakhit A et al.
Jan 2008
The effects of CYP3A4 inhibition on erlotinib pharmacokinetics: computer-based simulation (Simcyp) predicts in vivo metabolic inhibition.
European Journal of Clinical Pharmacology
64, 31-41, January 2008
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De Buck SS & Mackie CE
Dec 2007
Physiologically based approaches towards the prediction of pharmacokinetics: in vitro-in vivo extrapolation.
Expert Opinion on Drug Metabolism & Toxicology
3, 865-878, December 2007
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Einolf HJ
Oct 2007
Comparison of different approaches to predict metabolic drug-drug interactions.
Xenobiotica
37, 1257-1294, October-November 2007
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Riley RJ et al.
Feb 2007
Time-dependent CYP inhibition.
Expert Opinion on Drug Metabolism & Toxicology
3, 51-66, February 2007
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Ekins S et al.
Apr 2005
Techniques: application of systems biology to absorption, distribution, metabolism, excretion and toxicity.
Trends in Pharmacological Science
26, 202-209, April 2005
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Wishart DS
Mar 2005
Bioinformatics in drug development and assessment.
Drug Metabolism Reviews
37, 279-310, 2005
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