(Q50439761)

14 March 2018

title

Results from the IQ-CSRC prospective study support replacement of the thorough QT study by QT assessment in the early clinical phase. (English)

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14 March 2018

author

Christine Garnett

5

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author name string

B Darpo

1

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C Benson

2

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C Dota

3

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G Ferber

4

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C L Green

6

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V Jarugula

7

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L Johannesen

8

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J Keirns

9

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K Krudys

10

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J Liu

11

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C Ortemann-Renon

12

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S Riley

13

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N Sarapa

14

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B Smith

15

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R R Stoltz

16

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M Zhou

17

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N Stockbridge

18

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language of work or name

English

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publication date

1 April 2015

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Clinical Pharmacology & Therapeutics

published in

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volume

97

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issue

4

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page(s)

326-335

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14 March 2018

Spontaneous adverse event reports of serious ventricular arrhythmias, QT prolongation, syncope, and sudden death in patients treated with cisapride

cites work

1 reference

The significance of QT interval in drug development

21 January 2018

1 reference

Clinical evaluation of QT/QTc prolongation and proarrhythmic potential for nonantiarrhythmic drugs: the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use E14 guideline.

21 January 2018

1 reference

The cost-effectiveness of drug regulation: the example of thorough QT/QTc studies.

21 January 2018

1 reference

Early QT assessment--how can our confidence in the data be improved?

21 January 2018

1 reference

Early investigation of QTc liability: the role of multiple ascending dose (MAD) study

21 January 2018

1 reference

Statistical issues including design and sample size calculation in thorough QT/QTc studies

21 January 2018

1 reference

Concentration-QT relationships play a key role in the evaluation of proarrhythmic risk during regulatory review.

21 January 2018

1 reference

Creation of a knowledge management system for QT analyses

21 January 2018

1 reference

Statistical issues of QT prolongation assessment based on linear concentration modeling

21 January 2018

1 reference

Response to letter to the editor: Statistical issues of QT prolongation assessment based on linear concentration modeling by Yi Tsong et al.

21 January 2018

1 reference

Possible interethnic differences in quinidine-induced QT prolongation between healthy Caucasian and Korean subjects

21 January 2018

1 reference

The IQ-CSRC prospective clinical Phase 1 study: "Can early QT assessment using exposure response analysis replace the thorough QT study?".

21 January 2018

1 reference

The Cardiac Safety Research Consortium ECG database

21 January 2018

1 reference

The Cardiac Safety Research Consortium electrocardiogram warehouse: thorough QT database specifications and principles of use for algorithm development and testing

21 January 2018

1 reference

Levocetirizine does not prolong the QT/QTc interval in healthy subjects: results from a thorough QT study

21 January 2018

1 reference

Drug-induced prolongation of the QT interval: why the regulatory concern?

21 January 2018

1 reference

7 January 2021

Is a thorough QTc study necessary? The role of modeling and simulation in evaluating the QTc prolongation potential of drugs

1 reference

7 January 2021

Near-thorough QT study as part of a first-in-man study

1 reference

7 January 2021

Detection of QTc effects in small studies--implications for replacing the thorough QT study

1 reference

7 January 2021

Population Pharmacokinetic and Concentration-QTc Models for Moxifloxacin: Pooled Analysis of 20 Thorough QT Studies

1 reference

7 January 2021

Identifiers

DOI

10.1002/CPT.60

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14 March 2018

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14 March 2018