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5 research outputs found
Evaluation of Clinical Cardiac Safety of Itacitinib, a JAK1 Inhibitor, in Healthy Participants
Author
Anderson K
Boer J
+3 more
Darpo B
E14 Implementation Working Group
Srinivas N
Publication venue
'Wiley'
Publication date
Field of study
No full text
Crossref
Do Studies Evaluating QT/QTc Interval Prolongation with Dietary Supplements Meet FDA Standards: A Systematic Review
Author
Amy Kurian
Basch EM
+13 more
Buscemi S
Darpo B
E14 Implementation Working Group
Gahche J
Geelen A
Jack S
Jaja SI
Jessica Leong
Sachin A. Shah
Shekelle P
Snehal K
Tinh An Nguyen
Umang M. Patel
Publication venue
'Informa UK Limited'
Publication date
Field of study
No full text
Crossref
Pharmacokinetics, Pharmacodynamics and Safety of a Single Dose of Imarikiren, a Novel Renin Inhibitor, in Healthy Male Subjects
Author
European Medicines Agency Committee for Medicinal Products for Human Use
Imaeda
+5 more
International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use E14 Implementation Working Group
Mentz
Shafiq
United States Department of Health and Human Services Food and Drug Administration, Center for Drug Evaluation and Research
Vaidyanathan
Publication venue
'Wiley'
Publication date
Field of study
No full text
Crossref
ICH E14 Q&A(R2) document: commentary on the further updated recommendations on thorough QT studies
Author
Aitken
Ansermot
+28 more
Bouvy
Chae
Committee for Medicinal Products for Human Use (CHMP)
Committee for Medicinal Products for Human Use (CHMP)
Darpo
Dickmann
Florian
Frye
Grilo
Hartigan-Go
ICH E14 Implementation Working Group
International Conference on Harmonisation
Julian
Kato
Krantz
Lin
Mbai
McKibbin
Sager
Sager
Schmitt
Shah
Shah
Sánchez Hernández
Vorperian
Waldo
Zhang
Zhou
Publication venue
'Wiley'
Publication date
Field of study
No full text
Crossref
Core battery safety pharmacology testing – An assessment of its utility in early drug development
Author
Authier
Avila
+45 more
Baird
Baldrick
Baldrick
Baldrick
Baldrick
Baldrick
Cantilena
Chui
Derakhchan
Ducroq
Ewart
Fermini
Gauvin
Guth
Guth
Guth
Holzgrefe
ICH E14/S7B Implementation Working Group
ICH M3(R2)
ICH S6(R1)
ICH S7A
ICH S7B
ICH S9
Jackson
Katchman
Lindgren
Lu
McMahon
Mead
Milliken
Paglialunga
Prior
Pugsley
Redfern
Redfern
Travis
Turk
Vargas
Vargas
Vicente
Wallis
Walter
Ward
Webster
Yu
Publication venue
'Elsevier BV'
Publication date
Field of study
No full text
Crossref