(Q37982653)

26 August 2017

title

The role of physiologically based pharmacokinetic modeling in regulatory review (English)

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26 August 2017

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S-M Huang

1

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26 August 2017

M Rowland

series ordinal

2

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26 August 2017

language of work or name

English

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publication date

8 February 2012

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Clinical Pharmacology & Therapeutics

26 August 2017

published in

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26 August 2017

volume

91

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26 August 2017

issue

3

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26 August 2017

page(s)

542-549

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Physiologically-Based Pharmacokinetics in Drug Development and Regulatory Science

26 August 2017

cites work

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https://api.crossref.org/works/10.1038%2FCLPT.2011.320

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

21 January 2018

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https://api.crossref.org/works/10.1038%2FCLPT.2011.320

Evaluation of exposure change of nonrenally eliminated drugs in patients with chronic kidney disease using physiologically based pharmacokinetic modeling and simulation.

21 January 2018

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https://api.crossref.org/works/10.1038%2FCLPT.2011.320

Use of prescription and over-the-counter medications and dietary supplements among older adults in the United States

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21 January 2018

When good drugs go bad.

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https://api.crossref.org/works/10.1038%2FCLPT.2011.320

Drug interaction studies: study design, data analysis, and implications for dosing and labeling

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https://api.crossref.org/works/10.1038%2FCLPT.2011.320

New era in drug interaction evaluation: US Food and Drug Administration update on CYP enzymes, transporters, and the guidance process

21 January 2018

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https://api.crossref.org/works/10.1038%2FCLPT.2011.320

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

21 January 2018

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https://api.crossref.org/works/10.1038%2FCLPT.2011.320

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

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https://api.crossref.org/works/10.1038%2FCLPT.2011.320

AAPS workshop report: strategies to address therapeutic protein-drug interactions during clinical development

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Membrane transporters in drug development

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https://api.crossref.org/works/10.1038%2FCLPT.2011.320

SLCO1B1 variants and statin-induced myopathy--a genomewide study

21 January 2018

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https://api.crossref.org/works/10.1038%2FCLPT.2011.320

Interaction of HIV protease inhibitors with OATP1B1, 1B3, and 2B1.

21 January 2018

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https://api.crossref.org/works/10.1038%2FCLPT.2011.320

Physiologically based pharmacokinetic modeling to predict transporter-mediated clearance and distribution of pravastatin in humans

21 January 2018

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https://api.crossref.org/works/10.1038%2FCLPT.2011.320

Transporter pharmacogenetics and statin toxicity

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https://api.crossref.org/works/10.1038%2FCLPT.2011.320

Improving pediatric dosing through pediatric initiatives: what we have learned

21 January 2018

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Pediatric antihypertensive trial failures: analysis of end points and dose range

21 January 2018

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https://api.crossref.org/works/10.1038%2FCLPT.2011.320

The in silico child: using simulation to guide pediatric drug development and manage pediatric pharmacotherapy.

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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https://api.crossref.org/works/10.1038%2FCLPT.2011.320

7 January 2021

Therapeutic protein-drug interactions and implications for drug development

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https://api.crossref.org/works/10.1038%2FCLPT.2011.320

7 January 2021

Disease-drug-drug interaction involving tocilizumab and simvastatin in patients with rheumatoid arthritis

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https://api.crossref.org/works/10.1038%2FCLPT.2011.320

7 January 2021

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

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https://api.crossref.org/works/10.1038%2FCLPT.2011.320

7 January 2021

Clinical pharmacology as a cornerstone of orphan drug development

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https://api.crossref.org/works/10.1038%2FCLPT.2011.320

7 January 2021

Transporters in drug development: advancing on the Critical Path

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https://api.crossref.org/works/10.1038%2FCLPT.2011.320

7 January 2021

Identifiers

DOI

10.1038/CLPT.2011.320

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26 August 2017

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