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2006D-0344:
Guidance for Industry on Drug Interaction Studies--Study Design,
Data Analysis, and Implications for Dosing and Labeling
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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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| NAD1
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| 09/11/2006
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| FDA
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| FDA
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| 09/12/2006
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| 53696-53697
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| 11/13/2006
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| txt
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| Signature:
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| Jeffrey Shuren
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| GDL1
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| 09/11/2006
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| 09/11/2006
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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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| EC1
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| 09/26/2006
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| 09/25/2006
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| Other Government
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| french health products
safety agency
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| htm
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| Signature:
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| Hueber, Stephanie
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| EC2
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| 10/27/2006
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| 10/26/2006
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| Drug Industry
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| Puracyp, Inc.
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| pdf
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| Signature:
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| Kramer, Kyle
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| EC3
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| 10/30/2006
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| 10/27/2006
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| Health Professional
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| Ordway Research Institute
Drug Development Center
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| pdf
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| Signature:
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| Bertino, Joseph
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| EC4
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| 11/02/2006
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| 11/01/2006
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| Drug Industry
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| Eli Lilly and Company
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| pdf
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| Signature:
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| Knadler, Mary
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| EMC1
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| 11/01/2006
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| 11/01/2006
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| Private Industry
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| Novartis Pharmaceutical
Corporation
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| pdf
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| Signature:
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| Soraya Madani, Ph. D.
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| EC5
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| 11/03/2006
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| 11/02/2006
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| Other Organization
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| Clinical Pharmacology,
Quintiles Inc.
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| pdf
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| Signature:
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| Quintiles Inc., Clin. Pharmacology
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| C1
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| 11/08/2006
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| 11/07/2006
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| Drug Industry
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| Pharmaceutical Research and Manufacturers of America (PhRMA)
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| pdf
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| Signature:
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| Michael Garvin, Pharm.D.
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| EC6
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| 11/13/2006
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| 11/09/2006
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| Device Industry
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| BD Biosciences
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| htm
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| Signature:
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| Stresser, David
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| EC7
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| 11/13/2006
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| 11/10/2006
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| Drug Industry
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| Pfizer
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| pdf
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| Signature:
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| Murphy, William
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| EC8
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| 11/13/2006
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| 11/10/2006
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| Drug Industry
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| Procter and Gamble
Pharmaceuticals
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| pdf
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| Signature:
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| Galletta, Gary
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| EC9
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| 11/13/2006
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| 11/10/2006
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| Drug Industry
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| XenoTech, LLC
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| htm
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| Signature:
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| Parkinson, Andrew
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| EMC2
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| 11/14/2006
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| 11/13/2006
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| International Industry
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| Eisai Company, Ltd.
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| pdf
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| Signature:
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| Fumio Sagami, D. V. M., Ph.
D.
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| EMC3
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| 11/14/2006
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| 11/13/2006
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| Private Industry
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| Abbott Laboratories
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| pdf
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| Signature:
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| Douglas L Sporn
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| EMC4
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| 11/14/2006
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| 11/13/2006
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| Private Industry
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| Merck & Company,
Inc.
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| pdf
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| Signature:
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| Connie Robinson
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| C5
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| 11/09/2006
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| 11/08/2006
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| Drug Industry
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| Millennium Pharmaceuticals,
Inc.
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| pdf
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| Signature:
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| Robert G. Pietrusko, PharmD
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| C6
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| 11/13/2006
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| 11/10/2006
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| Drug Industry
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| P&G Pharmaceuticals,
Inc.
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| pdf
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| Signature:
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| Gary F. Galletta, PharmD
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| C7
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| 11/13/2006
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| 11/10/2006
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| Drug Industry
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| Sanofi-Synthelabo,
Inc.
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| pdf
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| Signature:
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| Richard P. Gural, PhD
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| C8
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| 11/13/2006
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| 11/10/2006
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| Drug Industry
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| Genentech, Inc.
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| pdf
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| Signature:
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| Genentech, Inc.
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| C9
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| 11/14/2006
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| 11/13/2006
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| Drug Industry
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| Wyeth Pharmaceuticals
(wyeth)
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| pdf
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| Signature:
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| Roy J. Baranello, Jr.
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| EMC5
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| 11/16/2006
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| 11/15/2006
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| Private Industry
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| Amgen Regulatory Affairs
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| pdf
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| Signature:
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| Jenny Peters
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| C10
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| 11/29/2006
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| 11/28/2006
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| Drug Industry
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| Boehringer-Ingelheim
Pharmaceuticals
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| pdf
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| Signature:
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| Mitchell E. Taub
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| C11
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| 12/06/2006
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| 12/02/2006
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| Device Industry
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| Absorption Systems
LP
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| pdf
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| Signature:
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| Ismael J. Hidalgo, PhD
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| C12
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| 12/22/2006
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| 12/21/2006
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| Drug Industry
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| Roche Pharmaceuticals
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| pdf
Attachment
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| Signature:
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| Cynthia Dinella, Pharm. D.
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| C13
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| 12/27/2006
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| 12/26/2006
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| Device Industry
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| In-Vitro technologies,
Inc.
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| pdf
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|
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| Signature:
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| Aruna Koganti, PhD
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| C14
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| 01/09/2007
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| 01/09/2007
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| Drug Industry
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| Bristol-Myers Squibb
Company
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|
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| pdf
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|
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| Signature:
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| Richard L Wolgemuth PhD
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Top
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Page last updated:
March 13, 2007
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