Applications of Physiologically Based Pharmacokinetic (PBPK) Modeling and Simulation During Regulatory Review (Q37824590)

23 August 2017

title

Applications of physiologically based pharmacokinetic (PBPK) modeling and simulation during regulatory review (English)

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23 August 2017

Applications of Physiologically Based Pharmacokinetic (PBPK) Modeling and Simulation During Regulatory Review (English)

1 reference

DOI

10.1038/CLPT.2010.298

https://api.crossref.org/works/10.1038/CLPT.2010.298

21 November 2024

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modelling biological systems

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21 November 2024

S-M Huang

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23 August 2017

P. Zhao

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21 November 2024

L. Zhang

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J. A. Grillo

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Q. Liu

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J. M. Bullock

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21 November 2024

Y. J. Moon

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21 November 2024

P. Song

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S. S. Brar

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R. Madabushi

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21 November 2024

T. C. Wu

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21 November 2024

B. P. Booth

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N. A. Rahman

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K. S. Reynolds

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E. Gil Berglund

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21 November 2024

L. J. Lesko

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21 November 2024

language of work or name

English

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publication date

29 December 2010

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Clinical Pharmacology & Therapeutics

23 August 2017

published in

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23 August 2017

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23 August 2017

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23 August 2017

page(s)

259-267

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A framework for assessing inter-individual variability in pharmacokinetics using virtual human populations and integrating general knowledge of physical chemistry, biology, anatomy, physiology and genetics: A tale of 'bottom-up' vs 'top-down' recogn

23 August 2017

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The Simcyp population-based ADME simulator

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Simulation and prediction of in vivo drug metabolism in human populations from in vitro data

21 January 2018

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Development of a physiology-based whole-body population model for assessing the influence of individual variability on the pharmacokinetics of drugs.

21 January 2018

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Prediction of the clearance of eleven drugs and associated variability in neonates, infants and children

21 January 2018

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Pharmacokinetic predictions in children by using the physiologically based pharmacokinetic modelling

21 January 2018

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Development and evaluation of a generic physiologically based pharmacokinetic model for children.

21 January 2018

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Population-based mechanistic prediction of oral drug absorption

21 January 2018

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Prediction of modified release pharmacokinetics and pharmacodynamics from in vitro, immediate release, and intravenous data

21 January 2018

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Physiology-based simulations of a pathological condition: prediction of pharmacokinetics in patients with liver cirrhosis

21 January 2018

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A semi-mechanistic model to predict the effects of liver cirrhosis on drug clearance

21 January 2018

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Assessing the efficiency of mixed effects modelling in quantifying metabolism based drug-drug interactions: using in vitro data as an aid to assess study power

21 January 2018

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Physiologically based mechanistic modelling to predict complex drug-drug interactions involving simultaneous competitive and time-dependent enzyme inhibition by parent compound and its metabolite in both liver and gut - the effect of diltiazem on th

21 January 2018

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The effects of dose staggering on metabolic drug-drug interactions.

21 January 2018

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Semiphysiologically based pharmacokinetic models for the inhibition of midazolam clearance by diltiazem and its major metabolite.

21 January 2018

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Stochastic prediction of CYP3A-mediated inhibition of midazolam clearance by ketoconazole

21 January 2018

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The use of mechanistic DM-PK-PD modelling to assess the power of pharmacogenetic studies -CYP2C9 and warfarin as an example

21 January 2018

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Comparative human pharmacokinetics and metabolism of single-dose oral and intravenous sildenafil

21 January 2018

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Quantitative prediction of in vivo drug-drug interactions from in vitro data based on physiological pharmacokinetics: use of maximum unbound concentration of inhibitor at the inlet to the liver

21 January 2018

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Safety, pharmacodynamics, and pharmacokinetics of single doses of BAY 59-7939, an oral, direct factor Xa inhibitor

21 January 2018

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Prediction of pharmacokinetics prior to in vivo studies. 1. Mechanism-based prediction of volume of distribution.

21 January 2018

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Tissue distribution of basic drugs: accounting for enantiomeric, compound and regional differences amongst beta-blocking drugs in rat.

21 January 2018

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Physiologically based pharmacokinetic modeling 1: predicting the tissue distribution of moderate-to-strong bases.

21 January 2018

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Physiologically based pharmacokinetic modelling 2: predicting the tissue distribution of acids, very weak bases, neutrals and zwitterions

21 January 2018

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Characterizing uncertainty and variability in physiologically based pharmacokinetic models: state of the science and needs for research and implementation.

21 January 2018

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Human clearance prediction: shifting the paradigm

21 January 2018

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Physiologically based pharmacokinetics in drug development and regulatory science: a workshop report (Georgetown University, Washington, DC, May 29-30, 2002).

21 January 2018

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The contribution of intestinal and hepatic CYP3A to the interaction between midazolam and clarithromycin

21 January 2018

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Pharmacokinetic interactions between sildenafil and saquinavir/ritonavir

21 January 2018

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The effects of steady-state erythromycin and azithromycin on the pharmacokinetics of sildenafil in healthy volunteers.

21 January 2018

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Is this the drug or dose for you? Impact and consideration of ethnic factors in global drug development, regulatory review, and clinical practice

21 January 2018

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7 January 2021

'In silico' simulations to assess the 'in vivo' consequences of 'in vitro' metabolic drug-drug interactions

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7 January 2021

Incorporating in vitro information on drug metabolism into clinical trial simulations to assess the effect of CYP2D6 polymorphism on pharmacokinetics and pharmacodynamics: dextromethorphan as a model application

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7 January 2021

Multiple-dose pharmacokinetics of ritonavir in human immunodeficiency virus-infected subjects

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7 January 2021

Prediction of in vivo interaction between triazolam and erythromycin based on in vitro studies using human liver microsomes and recombinant human CYP3A4

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7 January 2021

When to conduct a renal impairment study during drug development: US Food and Drug Administration perspective

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7 January 2021

Assessment of the impact of renal impairment on systemic exposure of new molecular entities: evaluation of recent new drug applications

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7 January 2021

Determination of volume of distribution at steady state with complete consideration of the kinetics of protein and tissue binding in linear pharmacokinetics

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7 January 2021

Identifiers

DOI

10.1038/CLPT.2010.298

1 reference

23 August 2017

1 reference