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Hepatotoxicity of Tyrosine Kinase Inhibitors: Clinical and Regulatory Perspectives

Drug safety, 2013-07, Vol.36 (7), p.491-503

2013

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Moxifloxacin‐induced QTc interval prolongations in healthy male Japanese and Caucasian volunteers: a direct comparison in a thorough QT study

British journal of clinical pharmacology, 2015-09, Vol.80 (3), p.446-459

2015

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Telavancin versus Standard Therapy for Treatment of Complicated Skin and Skin Structure Infections Caused by Gram-Positive Bacteria: FAST 2 Study

Antimicrobial Agents and Chemotherapy, 2006-03, Vol.50 (3), p.862-867

2006

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A Randomized Trial Comparing the Cardiac Rhythm Safety of Moxifloxacin vs Levofloxacin in Elderly Patients Hospitalized With Community-Acquired Pneumonia

Chest, 2005-11, Vol.128 (5), p.3398-3406

2005

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Update on Cardiovascular Safety of Tyrosine Kinase Inhibitors: With a Special Focus on QT Interval, Left Ventricular Dysfunction and Overall Risk/Benefit

Drug safety, 2015-08, Vol.38 (8), p.693-710

2015

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Cardiovascular Safety of Tyrosine Kinase Inhibitors: With a Special Focus on Cardiac Repolarisation (QT Interval)

Drug safety, 2013-05, Vol.36 (5), p.295-316

2013

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Dealing with Global Safety Issues: Was the Response to QT-Liability of Non-Cardiac Drugs Well Coordinated?

Drug safety, 2013-03, Vol.36 (3), p.167-182

2013

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Relations of QTc prolongation on the electrocardiogram to torsades de pointes : definitions and mechanisms

The American journal of cardiology, 1993-08, Vol.72 (6), p.10B-13B

MORGANROTH, J

1993

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Assessing Prolongation of the Corrected QT Interval with Bedaquiline and Delamanid Coadministration to Predict the Cardiac Safety of Simplified Dosing Regimens

Clinical pharmacology and therapeutics, 2022-10, Vol.112 (4), p.873-881

2022

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ICH E 14 Q & A ( R 1) document: perspectives on the updated recommendations on thorough QT studies

British journal of clinical pharmacology, 2013-04, Vol.75 (4), p.959-965

2013

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Early Investigation of QTc Liability: The Role of Multiple Ascending Dose (MAD) Study

Drug safety, 2012-09, Vol.35 (9), p.695-709

2012

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Early Investigation of QTc Liability

Drug safety, 2012-09, Vol.35 (9), p.695

2012

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QT EFFECTS OF BEDAQUILINE, DELAMANID OR BOTH IN PATIENTS WITH RIFAMPICIN-RESISTANT-TB: A RANDOMIZED CONTROLLED TRIAL

The Lancet infectious diseases, 2021-02, Vol.21 (7), p.975-983

2021

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ICH E14 Q & A (R1) document: perspectives on the updated recommendations on thorough QT studies

British journal of clinical pharmacology, 2013-04, Vol.75 (4), p.959-965

2013

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Risk factors for the development of proarrhythmic events

The American journal of cardiology, 1987-04, Vol.59 (11), p.E32-E37

Morganroth, Joel

1987

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ICH E14 Q&A(R2) document: commentary on the further updated recommendations on thorough QT studies

British journal of clinical pharmacology, 2015-03, Vol.79 (3), p.456-464

2015

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Effect of single doses of IV palonosetron, up to 2.25 mg, on the QTc interval duration: a double-blind, randomized, parallel group study in healthy volunteers

Supportive care in cancer, 2016-02, Vol.24 (2), p.621-627

2016

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A definitive or thorough phase 1 QT ECG trial as a requirement for drug safety assessment

Journal of electrocardiology, 2004, Vol.37 (1), p.25-29

Morganroth, Joel

2004

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Bupivacaine extended-release liposome injection exhibits a favorable cardiac safety profile

Regional anesthesia and pain medicine, 2012-03, Vol.37 (2), p.145-151

2012

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Proarrhythmic potential of reverse use-dependent drugs

Journal of electrocardiology, 2007-09, Vol.40 (5), p.432-433

2007

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Replacing the thorough QT study: reflections of a baby in the bath water

British journal of clinical pharmacology, 2014-08, Vol.78 (2), p.195-201

2014

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Effects of buprenorphine on QT intervals in healthy subjects: results of 2 randomized positive- and placebo-controlled trials

Postgraduate medicine, 2017-01, Vol.129 (1), p.69-80

2017

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Moxifloxacin‐induced QT c interval prolongations in healthy male Japanese and Caucasian volunteers: a direct comparison in a thorough QT study

British journal of clinical pharmacology, 2015-09, Vol.80 (3), p.446-459

2015

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Benefits of Centralized ECG Reading in Clinical Oncology Studies

Therapeutic innovation & regulatory science, 2016-01, Vol.50 (1), p.123-129

2016

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Hepatotoxicity of Tyrosine Kinase Inhibitors: Clinical and Regulatory Perspectives

Moxifloxacin‐induced QTc interval prolongations in healthy male Japanese and Caucasian volunteers: a direct comparison in a thorough QT study

Telavancin versus Standard Therapy for Treatment of Complicated Skin and Skin Structure Infections Caused by Gram-Positive Bacteria: FAST 2 Study

A Randomized Trial Comparing the Cardiac Rhythm Safety of Moxifloxacin vs Levofloxacin in Elderly Patients Hospitalized With Community-Acquired Pneumonia

Update on Cardiovascular Safety of Tyrosine Kinase Inhibitors: With a Special Focus on QT Interval, Left Ventricular Dysfunction and Overall Risk/Benefit

Cardiovascular Safety of Tyrosine Kinase Inhibitors: With a Special Focus on Cardiac Repolarisation (QT Interval)

Dealing with Global Safety Issues: Was the Response to QT-Liability of Non-Cardiac Drugs Well Coordinated?

QT effects of bedaquiline, delamanid, or both in patients with rifampicin-resistant tuberculosis: a phase 2, open-label, randomised, controlled trial

Relations of QTc prolongation on the electrocardiogram to torsades de pointes : definitions and mechanisms

Assessing Prolongation of the Corrected QT Interval with Bedaquiline and Delamanid Coadministration to Predict the Cardiac Safety of Simplified Dosing Regimens

ICH E 14 Q & A ( R 1) document: perspectives on the updated recommendations on thorough QT studies

Early Investigation of QTc Liability: The Role of Multiple Ascending Dose (MAD) Study

Early Investigation of QTc Liability

QT EFFECTS OF BEDAQUILINE, DELAMANID OR BOTH IN PATIENTS WITH RIFAMPICIN-RESISTANT-TB: A RANDOMIZED CONTROLLED TRIAL

ICH E14 Q & A (R1) document: perspectives on the updated recommendations on thorough QT studies

Risk factors for the development of proarrhythmic events

ICH E14 Q&A(R2) document: commentary on the further updated recommendations on thorough QT studies

Effect of single doses of IV palonosetron, up to 2.25 mg, on the QTc interval duration: a double-blind, randomized, parallel group study in healthy volunteers

A definitive or thorough phase 1 QT ECG trial as a requirement for drug safety assessment

Bupivacaine extended-release liposome injection exhibits a favorable cardiac safety profile

Proarrhythmic potential of reverse use-dependent drugs

Replacing the thorough QT study: reflections of a baby in the bath water

Effects of buprenorphine on QT intervals in healthy subjects: results of 2 randomized positive- and placebo-controlled trials

Moxifloxacin‐induced QT c interval prolongations in healthy male Japanese and Caucasian volunteers: a direct comparison in a thorough QT study

Benefits of Centralized ECG Reading in Clinical Oncology Studies

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