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2004D-0378:
INTERNATIONAL CONFERENCE ON HARMONISATION; DRAFT GUIDANCE ON S7B
NONCLINICAL EVALUATION OF THE POTENTIAL FOR DELAYED VENTRICULAR
REPOLARIZATION (QT INTERVAL PROLONGATION) BY HUMAN PHARMACEUTICALS
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| Document #
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| Received Date
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| Filed
Date
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| Submitter Code
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| Submitter
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| FR
Date
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| FR
Page
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| Comment Date
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| Files
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| Remarks
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| GDL1
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| 09/10/2004
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| 09/10/2004
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| Federal
Government
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| Guidance
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| pdf
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| Signature:
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| Guidance
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| NAD1
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| 09/10/2004
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| FDA
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| FDA
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| 09/13/2004
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| 55164-55164
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| 12/13/2004
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| pdf
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| Signature:
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| HUBBARD, WILLIAM
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| EC1
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| 11/12/2004
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| 11/11/2004
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| Drug Industry
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| ChanTest, Inc.
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| htm,
Attachment doc, pdf
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| Signature:
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| Brown, Arthur
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| EXT1
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| 12/13/2004
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| 12/10/2004
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| Drug Industry
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| Wyeth Pharmaceuticals
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| pdf
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| Signature:
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| Roy J. Baranello,
Jr.
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| C1
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| 12/10/2004
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| 12/10/2004
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| Drug Industry
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| Merck & Co., Inc.
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| pdf,
Attachment
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| Signature:
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| Lauren M. Hetrick
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| C2
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| 12/08/2004
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| 12/07/2004
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| Drug Industry
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| AstraZeneca Pharmaceuticals,
LP
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| pdf
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| Signature:
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| Lewis B. Kinter, PhD
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| C3
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| 12/13/2004
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| 12/10/2004
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| Drug Industry
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| Schering-Plough
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| pdf
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| Signature:
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| Alan Stuart Bass,
PhD and Ying-Ying
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| EC2
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| 12/14/2004
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| 12/13/2004
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| Drug Industry
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| GlaxoSmithKline
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| htm,
Attachment
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| Signature:
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| Bowers, Alison
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| EC3
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| 12/14/2004
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| 12/13/2004
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| Drug Industry
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| Pfizer Inc
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| htm,
Attachments: 1pdf
/ 2pdf, 2doc
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| Signature:
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| Murphy, William
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| C4
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| 12/14/2004
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| 12/13/2004
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| Drug Industry
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| GlaxoSmithKline (GSK)
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| pdf
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| Signature:
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| Alison Bowers
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| C5
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| 12/14/2004
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| 12/13/2004
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| Drug Industry
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| Pfizer, Inc.
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| pdf
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| Signature:
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| William R. Murphy
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| C6
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| 12/14/2004
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| 12/13/2004
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| Drug Industry
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| Bristol-Myers Squibb
Company
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| pdf
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| Signature:
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| Richard L. Wolgemuth,
Ph.D.
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| C7
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| 12/13/2004
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| 12/13/2004
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| Drug Industry
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| Abbott Laboratories
(Abbott)
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| pdf
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| Signature:
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| Douglas L. Sporn
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| NEC1
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| 01/04/2005
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| FDA
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| FDA
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| 01/05/2005
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| 823-824
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| 02/18/2005
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| pdf
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| Signature:
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| HUBBARD, WILLIAM
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| C8
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| 12/23/2004
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| 12/22/2004
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| Drug Industry
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| Wyeth Pharmaceuticals
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| pdf
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| Signature:
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| Roy J. Baranello,
Jr.
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Top | Up
Page last updated
January 24, 2005
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