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

2015 ◽  
Vol 79 (3) ◽  
pp. 456-464 ◽  
Author(s):  
Rashmi R. Shah ◽  
Joel Morganroth ◽  
Robert B. Kleiman
Keyword(s):  
Ich E14

Drugs, QTc Interval Prolongation and Final ICH E14 Guideline

Drug Safety ◽  
2005 ◽  
Vol 28 (11) ◽  
pp. 1009-1028 ◽  
Author(s):  
Rashmi R Shah
Keyword(s):  
Qtc Interval ◽  
Interval Prolongation ◽  
Qtc Interval Prolongation ◽  
Ich E14

scholarly journals Highly Automated QT Measurement Techniques in 7 Thorough QT Studies Implemented under ICH E14 Guidelines

2011 ◽  
Vol 16 (1) ◽  
pp. 13-24 ◽  
Author(s):  
Jean-Philippe Couderc ◽  
Christine Garnett ◽  
Mike Li ◽  
Robert Handzel ◽  
Scott McNitt ◽  
...  
Keyword(s):  
Measurement Techniques ◽  
Ich E14

ICH E14-Compatible Holter Bin Method and its Equivalence to Individual Heart Rate Correction in the Assessment of Drug-Induced QT Changes

2014 ◽  
Vol 25 (11) ◽  
pp. 1232-1241 ◽  
Author(s):  
MAREK MALIK ◽  
KATERINA HNATKOVA ◽  
DONNA KOWALSKI ◽  
JAMES J. KEIRNS ◽  
E. MARCEL VAN GELDEREN
Keyword(s):  
Heart Rate ◽  
Drug Induced ◽  
Ich E14 ◽  
Heart Rate Correction ◽  
Bin Method

ICH E14: A New Regulatory Guidance on the Clinical Evaluation of QT/QTc Internal Prolongation and Proarrhythmic Potential for Non-antiarrhythmic Drugs

2005 ◽  
Vol 39 (4) ◽  
pp. 387-394 ◽  
Author(s):  
Philip T. Sager ◽  
Thierry Nebout ◽  
Borje Darpo
Keyword(s):  
Clinical Evaluation ◽  
Antiarrhythmic Drugs ◽  
Regulatory Guidance ◽  
Ich E14

scholarly journals Effects of combined netupitant and palonosetron (NEPA), a cancer supportive care antiemetic, on the ECG of healthy subjects: an ICH E14 thorough QT trial

SpringerPlus ◽  
2014 ◽  
Vol 3 (1) ◽  
Author(s):  
Tulla Spinelli ◽  
Cecilia Moresino ◽  
Sybille Baumann ◽  
Wolfgang Timmer ◽  
Armin Schultz
Keyword(s):  
Supportive Care ◽  
Healthy Subjects ◽  
Ich E14

S1033 Results of a Thorough QT Study (ICH E14) Testing a Novel Gastrointestinal Prokinetic, ATI-7505, Show NO ECG Effects at Therapeutic and Supra-Therapeutic Doses

2010 ◽  
Vol 138 (5) ◽  
pp. S-164-S-165 ◽  
Author(s):  
Peter G. Milner ◽  
Daniel M. Canafax ◽  
Monica Palme ◽  
Joel Morganroth
Keyword(s):  
Thorough Qt Study ◽  
Ich E14 ◽  
Therapeutic Doses

Experience in QT evaluation of oncology drug products since ICH E14 guidance

2008 ◽  
Vol 26 (15_suppl) ◽  
pp. 2554-2554 ◽  
Author(s):  
Q. Liu ◽  
R. Madabushi ◽  
C. Garnett ◽  
B. Booth
Keyword(s):  
Drug Products ◽  
Oncology Drug ◽  
Ich E14

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

2013 ◽  
Vol 75 (4) ◽  
pp. 959-965 ◽  
Author(s):  
Rashmi R. Shah ◽  
Joel Morganroth
Keyword(s):  
Ich E14

scholarly journals Implications of the IQ-CSRC Prospective Study: Time to Revise ICH E14

Drug Safety ◽  
2015 ◽  
Vol 38 (9) ◽  
pp. 773-780 ◽  
Author(s):  
Borje Darpo ◽  
Christine Garnett ◽  
James Keirns ◽  
Norman Stockbridge
Keyword(s):  
Prospective Study ◽  
Study Time ◽  
Ich E14
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