The cost-effectiveness of drug regulation: the example of thorough QT/QTc studies.
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Computer-based prediction of the drug proarrhythmic effect: problems, issues, known and suspected challengesEarly QT assessment--how can our confidence in the data be improved?Drug-drug interactions and QT prolongation as a commonly assessed cardiac effect - comprehensive overview of clinical trialsKey Challenges and Opportunities Associated with the Use of In Vitro Models to Detect Human DILI: Integrated Risk Assessment and Mitigation PlansQT dynamics during treatment with sertindoleICH E14 Q & A (R1) document: perspectives on the updated recommendations on thorough QT studies.Early investigation of QTc liability: the role of multiple ascending dose (MAD) study.The risks of risk aversion in drug regulation.The IQ-CSRC prospective clinical Phase 1 study: "Can early QT assessment using exposure response analysis replace the thorough QT study?".Use of Early Clinical Trial Data to Support Thorough QT Study Waiver for Upadacitinib and Utility of Food Effect to Demonstrate ECG Assay Sensitivity.Model averaging for robust assessment of QT prolongation by concentration-response analysis.Cardiovascular safety of antipsychotics: a clinical overview.Active Surveillance versus Spontaneous Reporting for First-Line Antiretroviral Medicines in Namibia: A Cost-Utility Analysis.Sentinel site active surveillance of safety of first-line antiretroviral medicines in Namibia.The Power of Phase I Studies to Detect Clinical Relevant QTc Prolongation: A Resampling Simulation Study.Are ECG monitoring recommendations before prescription of QT-prolonging drugs applied in daily practice? The example of haloperidol.Early Drug Discovery Prediction of Proarrhythmia Potential and Its CovariatesICH E14 Q&A(R2) document: commentary on the further updated recommendations on thorough QT studies.Replacing the thorough QT study: reflections of a baby in the bath water.The thorough QT study - do we need more of the same?Estimating the incremental net health benefit of requirements for cardiovascular risk evaluation for diabetes therapies.Mandatory electrocardiographic monitoring in young patients treated with psychoactive drugs.Nonclinical cardiovascular safety of pitolisant: comparing International Conference on Harmonization S7B and Comprehensive in vitro Pro-arrhythmia Assay initiative studies.Enabling robust assessment of QTc prolongation in early phase clinical trials.Results from the IQ-CSRC prospective study support replacement of the thorough QT study by QT assessment in the early clinical phase.Implications of the IQ-CSRC Prospective Study: Time to Revise ICH E14.Evaluating cardiac risk: exposure response analysis in early clinical drug development.Effects of atypical antipsychotic drugs on QT interval in patients with mental disorders.Withdrawal of prenylamine: perspectives on pharmacological, clinical and regulatory outcomes following the first QT-related casualty
P2860
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P2860
The cost-effectiveness of drug regulation: the example of thorough QT/QTc studies.
description
2011 nî lūn-bûn
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2011年の論文
@ja
2011年学术文章
@wuu
2011年学术文章
@zh
2011年学术文章
@zh-cn
2011年学术文章
@zh-hans
2011年学术文章
@zh-my
2011年学术文章
@zh-sg
2011年學術文章
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2011年學術文章
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name
The cost-effectiveness of drug regulation: the example of thorough QT/QTc studies.
@en
The cost-effectiveness of drug regulation: the example of thorough QT/QTc studies.
@nl
type
label
The cost-effectiveness of drug regulation: the example of thorough QT/QTc studies.
@en
The cost-effectiveness of drug regulation: the example of thorough QT/QTc studies.
@nl
prefLabel
The cost-effectiveness of drug regulation: the example of thorough QT/QTc studies.
@en
The cost-effectiveness of drug regulation: the example of thorough QT/QTc studies.
@nl
P2093
P2860
P356
P1476
The cost-effectiveness of drug regulation: the example of thorough QT/QTc studies
@en
P2093
H Schellekens
M A Koopmanschap
P2860
P304
P356
10.1038/CLPT.2011.224
P407
P50
P577
2011-12-28T00:00:00Z