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Public
Meeting for Levothyroxine Sodium Therapeutic Equivalence
May 23, 2005, Washington, DC
Presentations
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Overview of FDA General Regulatory Requirements and
Methods for Demonstration of Therapeutic Equivalence [PPT],
Dale P. Conner, Pharm.D., FDA
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Report of Recently Approved Products’ Performance in
Bioequivalence Testing [PPT],
Barbara M. Davit, Ph.D, FDA
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Levothyroxine Sodium Tables: An FDA Overview from
the CMC Standpoint [PPT], Eric
P. Duffy, PhD, FDA
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Limitations of Current Bioequivalence Standards [PPT],
James V. Hennessey M.D., Brown Medical School
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Levothyroxine Sodium: A Widely Employed Narrow
Therapeutic Range Drug [PPT],
Paul W. Ladenson, M.D. Johns Hopkins Univrsity School of
Medicine
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Results of Two T4 Bioavailability Studies [PPT],
Michael J. Lamson, Ph.D. King Pharmaceuticals
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Levothyroxine Therapeutic Equivalence Workshop:
Presentation Before the Food and Drug Administration [PPT],
John Leonard, MD, Abbott
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Use of TSH for Bioequivalence [PPT],
Robert Lionberger, Ph.D., FDA
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Bioavailability/Bioequivalence Studies in Evaluation
of New Levothyroxine Products [PPT],
Hank Malinowski, Ph.D., FDA
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FDA Summary [PPT],
David G. Orloff, M.D., FDA
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TSH as a Pharmacodynamic Marker Why do We Need It? [PPT],
E. Chester Ridgway, M.D., University of Colorado Health Sciences
Center
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FDA Levothyroxine Workshop [PPT],
Representatives from Sandoz
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Levothyroxine and/or TSH for Determination of
Bioequivalence: Study Design Considerations [PPT],
Steven I. Sherman, M.D., University of Texas M.D. Anderson Cancer
Center
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Presentation for Joint Public Meeting on Equivalence
of Levothyroxine Sodium Products [PPT],
Frank Sisto, Mylan Pharmaceuticals
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Concerns regarding Dispensing Practices and
Bioequivalence of Levothyroxine [PPT],
Leonard Wartofsky, M.D., Washington Hospital Center
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Date created: May 31,
2005 |
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