(Q37770955)

22 August 2017

1 reference

title

Clinical trial simulation: a review (English)

1 reference

22 August 2017

N Holford

1

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22 August 2017

S C Ma

series ordinal

2

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22 August 2017

B A Ploeger

series ordinal

3

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22 August 2017

language of work or name

English

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publication date

7 July 2010

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Clinical Pharmacology & Therapeutics

22 August 2017

published in

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22 August 2017

volume

88

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22 August 2017

issue

2

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22 August 2017

page(s)

166-182

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Simulation of clinical trials

22 August 2017

cites work

1 reference

https://api.crossref.org/works/10.1038%2FCLPT.2010.114

Simulation for clinical research trials: a theoretical outline.

21 January 2018

1 reference

https://api.crossref.org/works/10.1038%2FCLPT.2010.114

Role of modelling and simulation in Phase I drug development

21 January 2018

1 reference

https://api.crossref.org/works/10.1038%2FCLPT.2010.114

Model-based drug development

21 January 2018

1 reference

https://api.crossref.org/works/10.1038%2FCLPT.2010.114

Pharmacokinetics/Pharmacodynamics and the stages of drug development: role of modeling and simulation

21 January 2018

1 reference

https://api.crossref.org/works/10.1038%2FCLPT.2010.114

Model-based drug development: the road to quantitative pharmacology

21 January 2018

1 reference

https://api.crossref.org/works/10.1038%2FCLPT.2010.114

Utilisation of pharmacokinetic-pharmacodynamic modelling and simulation in regulatory decision-making

21 January 2018

1 reference

https://api.crossref.org/works/10.1038%2FCLPT.2010.114

Leveraging prior quantitative knowledge to guide drug development decisions and regulatory science recommendations: impact of FDA pharmacometrics during 2004-2006.

21 January 2018

1 reference

https://api.crossref.org/works/10.1038%2FCLPT.2010.114

The role of sexually transmitted infections in male circumcision effectiveness against HIV--insights from clinical trial simulation.

21 January 2018

1 reference

https://api.crossref.org/works/10.1038%2FCLPT.2010.114

Development of a safe and effective pediatric dosing regimen for sotalol based on population pharmacokinetics and pharmacodynamics in children with supraventricular tachycardia

21 January 2018

1 reference

https://api.crossref.org/works/10.1038%2FCLPT.2010.114

Clinical trial simulations for dosage optimization of docetaxel in patients with liver dysfunction, based on a log-binominal regression for febrile neutropenia

21 January 2018

1 reference

https://api.crossref.org/works/10.1038%2FCLPT.2010.114

Long-term safety and effectiveness of etanercept in children with selected categories of juvenile idiopathic arthritis

21 January 2018

1 reference

https://api.crossref.org/works/10.1038%2FCLPT.2010.114

Tailor-made drug treatment for children: creation of an infrastructure for data-sharing and population PK-PD modeling

21 January 2018

1 reference

https://api.crossref.org/works/10.1038%2FCLPT.2010.114

Mechanism-based concepts of size and maturity in pharmacokinetics

21 January 2018

1 reference

https://api.crossref.org/works/10.1038%2FCLPT.2010.114

Human renal function maturation: a quantitative description using weight and postmenstrual age.

21 January 2018

1 reference

https://api.crossref.org/works/10.1038%2FCLPT.2010.114

Population pharmacokinetic model for gatifloxacin in pediatric patients

21 January 2018

1 reference

https://api.crossref.org/works/10.1038%2FCLPT.2010.114

Learning versus confirming in clinical drug development

21 January 2018

1 reference

https://api.crossref.org/works/10.1038%2FCLPT.2010.114

A mathematical model for paroxetine antidepressant effect time course and its interaction with pindolol

21 January 2018

1 reference

https://api.crossref.org/works/10.1038%2FCLPT.2010.114

Paroxetine with pindolol augmentation: a double-blind, randomized, placebo-controlled study in depressed in-patients

21 January 2018

1 reference

https://api.crossref.org/works/10.1038%2FCLPT.2010.114

Use of quantitative pharmacology in the development of HAE1, a high-affinity anti-IgE monoclonal antibody

21 January 2018

1 reference

https://api.crossref.org/works/10.1038%2FCLPT.2010.114

Application of clinical trial simulation to compare proof-of-concept study designs for drugs with a slow onset of effect; an example in Alzheimer's disease.

21 January 2018

1 reference

https://api.crossref.org/works/10.1038%2FCLPT.2010.114

Modeling and simulation to support dose selection and clinical development of SC-75416, a selective COX-2 inhibitor for the treatment of acute and chronic pain

21 January 2018

1 reference

https://api.crossref.org/works/10.1038%2FCLPT.2010.114

Modeling and stimulation for clinical trial design involving a categorical response: a phase II case study with naratriptan

21 January 2018

1 reference

https://api.crossref.org/works/10.1038%2FCLPT.2010.114

Disease progression and pharmacodynamics in Parkinson disease - evidence for functional protection with levodopa and other treatments.

21 January 2018

1 reference

https://api.crossref.org/works/10.1038%2FCLPT.2010.114

Quantitative description of loss of clinical benefit following withdrawal of levodopa-carbidopa and bromocriptine in early Parkinson's disease

21 January 2018

1 reference

https://api.crossref.org/works/10.1038%2FCLPT.2010.114

Washout and delayed start designs for identifying disease modifying effects in slowly progressive diseases using disease progression analysis

21 January 2018

1 reference

https://api.crossref.org/works/10.1038%2FCLPT.2010.114

The use of clinical trial simulation to support dose selection: application to development of a new treatment for chronic neuropathic pain

21 January 2018

1 reference

https://api.crossref.org/works/10.1038%2FCLPT.2010.114

Clinical trial simulation using therapeutic effect modeling: application to ivabradine efficacy in patients with angina pectoris

21 January 2018

1 reference

https://api.crossref.org/works/10.1038%2FCLPT.2010.114

Population PK-PD model for Fc-osteoprotegerin in healthy postmenopausal women

21 January 2018

1 reference

https://api.crossref.org/works/10.1038%2FCLPT.2010.114

Optimization of the intravenous glucose tolerance test in T2DM patients using optimal experimental design.

21 January 2018

1 reference

https://api.crossref.org/works/10.1038%2FCLPT.2010.114

Adaptive-optimal design in PET occupancy studies.

21 January 2018

1 reference

https://api.crossref.org/works/10.1038%2FCLPT.2010.114

Predicting the outcome of phase III trials using phase II data: a case study of clinical trial simulation in late stage drug development

21 January 2018

1 reference

https://api.crossref.org/works/10.1038%2FCLPT.2010.114

Levodopa and the progression of Parkinson's disease

21 January 2018

1 reference

https://api.crossref.org/works/10.1038%2FCLPT.2010.114

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

1 reference

https://api.crossref.org/works/10.1038%2FCLPT.2010.114

7 January 2021

Population pharmacokinetic analysis and simulation of the time-concentration profile of etanercept in pediatric patients with juvenile rheumatoid arthritis

1 reference

https://api.crossref.org/works/10.1038%2FCLPT.2010.114

7 January 2021

Levodopa slows progression of Parkinson's disease: external validation by clinical trial simulation

1 reference

https://api.crossref.org/works/10.1038%2FCLPT.2010.114

7 January 2021

Safety and efficacy of once-weekly application of Etanercept in children with juvenile idiopathic arthritis

1 reference

https://api.crossref.org/works/10.1038%2FCLPT.2010.114

7 January 2021

Clinical trial simulations in pediatric patients using realistic covariates: application to teduglutide, a glucagon-like peptide-2 analog in neonates and infants with short-bowel syndrome

1 reference

https://api.crossref.org/works/10.1038%2FCLPT.2010.114

7 January 2021

Clinical trial simulation of docetaxel in patients with cancer as a tool for dosage optimization

1 reference

https://api.crossref.org/works/10.1038%2FCLPT.2010.114

7 January 2021

A kinetic-pharmacodynamic model for clinical trial simulation of antidepressant action: application to clomipramine-lithium interaction

1 reference

https://api.crossref.org/works/10.1038%2FCLPT.2010.114

7 January 2021

Simulation of correlated continuous and categorical variables using a single multivariate distribution

1 reference

https://api.crossref.org/works/10.1038%2FCLPT.2010.114

7 January 2021

Trial Treatment Length Optimization With an Emphasis on Disease Progression Studies

1 reference

https://api.crossref.org/works/10.1038%2FCLPT.2010.114

7 January 2021

Identifiers

DOI

10.1038/CLPT.2010.114

1 reference

22 August 2017

1 reference