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, Dale P. Conner, Pharm.D., FDA
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Report of Recently Approved Products’ Performance in Bioequivalence Testing, Barbara M. Davit, Ph.D, FDA
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Levothyroxine Sodium Tables: An FDA Overview from the CMC Standpoint, Eric P. Duffy, PhD, FDA
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Limitations of Current Bioequivalence Standards, James V. Hennessey M.D., Brown Medical School
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Levothyroxine Sodium: A Widely Employed Narrow Therapeutic Range Drug, Paul W. Ladenson, M.D. Johns Hopkins Univrsity School of Medicine
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Results of Two T4 Bioavailability Studies, Michael J. Lamson, Ph.D. King Pharmaceuticals
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Levothyroxine Therapeutic Equivalence Workshop: Presentation Before the Food and Drug Administration, John Leonard, MD, Abbott
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Use of TSH for Bioequivalence, Robert Lionberger, Ph.D., FDA
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Bioavailability/Bioequivalence Studies in Evaluation of New Levothyroxine Products (PDF - 226KB), Hank Malinowski, Ph.D., FDA
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FDA Summary, David G. Orloff, M.D., FDA
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TSH as a Pharmacodynamic Marker Why do We Need It?, E. Chester Ridgway, M.D., University of Colorado Health Sciences Center
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FDA Levothyroxine Workshop, Representatives from Sandoz
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Levothyroxine and/or TSH for Determination of Bioequivalence: Study Design Considerations, 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, Frank Sisto, Mylan Pharmaceuticals
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Concerns regarding Dispensing Practices and Bioequivalence of Levothyroxine, Leonard Wartofsky, M.D., Washington Hospital Center