(Q44069328)

29 November 2017

title

Effect of number of replicate electrocardiograms recorded at each time point in a thorough QT study on sample size and study cost (English)

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29 November 2017

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Mili Natekar

1

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29 November 2017

Pooja Hingorani

2

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29 November 2017

Pallavi Gupta

3

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29 November 2017

Dilip R Karnad

4

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29 November 2017

Snehal Kothari

5

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29 November 2017

Michiel de Vries

6

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29 November 2017

Troy Zumbrunnen

7

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29 November 2017

Dhiraj Narula

8

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29 November 2017

language of work or name

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17 September 2010

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The Journal of Clinical Pharmacology

29 November 2017

published in

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29 November 2017

volume

51

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29 November 2017

issue

6

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29 November 2017

page(s)

908-914

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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.

29 November 2017

cites work

1 reference

https://api.crossref.org/works/10.1177%2F0091270010376962

QT effects of duloxetine at supratherapeutic doses: a placebo and positive controlled study.

21 January 2018

1 reference

https://api.crossref.org/works/10.1177%2F0091270010376962

Evaluation of drug-induced QT interval prolongation: implications for drug approval and labelling

21 January 2018

1 reference

https://api.crossref.org/works/10.1177%2F0091270010376962

Update on the evaluation of a new drug for effects on cardiac repolarization in humans: issues in early drug development

21 January 2018

1 reference

https://api.crossref.org/works/10.1177%2F0091270010376962

Comparison of semiautomated and fully automated methods for QT measurement during a thorough QT/QTc study: variability and sample size considerations.

21 January 2018

1 reference

https://api.crossref.org/works/10.1177%2F0091270010376962

The effect of moxifloxacin on QTc and implications for the design of thorough QT studies

21 January 2018

1 reference

https://api.crossref.org/works/10.1177%2F0091270010376962

The combined use of ibutilide as an active control with intensive electrocardiographic sampling and signal averaging as a sensitive method to assess the effects of tadalafil on the human QT interval

21 January 2018

1 reference

https://api.crossref.org/works/10.1177%2F0091270010376962

Sample size, power calculations, and their implications for the cost of thorough studies of drug induced QT interval prolongation

21 January 2018

1 reference

https://api.crossref.org/works/10.1177%2F0091270010376962

Sample size calculations in thorough QT studies.

21 January 2018

1 reference

https://api.crossref.org/works/10.1177%2F0091270010376962

Investigating Drug-Induced QT and QTc Prolongation in the Clinic: A Review of Statistical Design and Analysis Considerations: Report from the Pharmaceutical Research and Manufacturers of America QT Statistics Expert Team

21 January 2018

1 reference

https://api.crossref.org/works/10.1177%2F0091270010376962

21 January 2018

Identifiers

DOI

10.1177/0091270010376962

1 reference

29 November 2017

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