Drug Development and Drug Interactions: Presentations

2007

• Drug Interactions & Labeling- Issues Beyond the Font Size [PDF]
  November 16, 2007
  Shiew-Mei Huang
  UCSF/AAPS- Dr. Les Benet Symposium
  The Impact of Pharmacokinetics in Modern Drug Development—10 Years Later
  San Francisco, CA
  
• FDA Critical Path Initiatives: Opportunities for Drug Development, Regulatory Review and Clinical Practice [PDF]
  November 14, 2007
  Shiew-Mei Huang
  AAPS Annual meeting
  Hot Topics Discussion
  San Diego, CA
  
• Making a Decision on Drug Metabolism Data: Go or No Go Human-specific Metabolites -Regulatory Perspective- [PDF]
  November 12, 2007
  Shiew-Mei Huang
  AAPS Pharmacokinetics, Pharmacodynamics and Drug Metabolism
  San Diego, CA
  
• Enzyme- and Transporter-Based Drug Interactions: Progress and Future Challenges: Regulatory Aspect of Drug-Drug Interactions [PDF]
  November 10, 2007
  Shiew-Mei Huang
  AAPS/ISSX Workshop
  Satellite Program of 2007 AAPS Annual Meeting
  San Diego, CA
  

2006

• "FDA Perspectives on Drug Transporters and Their Role in Drug Interactions" [PDF]
  Shiew-Mei Haung
  EUFEPS Conference on Membrane Drug Transporters: Impact on Drug Discovery, Development, Regulation and Usuage, Copenhagen, Denmark, September 25, 2006
  
  
• "Risk of Drug Interactions involving Herbal and Citrus Products" [PDF]
  Shiew-Mei Huang
  Health Canada International Symposium on Drug, Food, and Natural Health Product Interactions February 9, 2006, Gatineau, Quebec.

2005

• "Drug -Natural Product Interactions-Labeling Implications" [PDF]
  Huang, S-M
  AAPS Annual Meeting, November 10, 2005, Nashville, TN.
  
  
• "Drug Interaction Studies — Study Design, Data Analysis, and Implications for Dosing and Labeling: Current Opinion" [HTML] [PDF]
  Huang, S-M, Reynolds KS, Strong JM, Nallani S, Lesko LJ, Temple R, Abraham S, Alhabet S, Baweja R, Chung S, Colangelo P, Collins J, Frucht D, Green MD, Hepp P, Kavanagh R, Ko HS, Marroum P, Norden J, Qiu W, Rahman A, Sobel S, Stifano T, Wei X, Yasuda S, Zhang L, Zheng JH
  FDA Science Forum, April 26-28, 2005, Washington D.C.
  
  
• "An FDA View of Drug Transporters and What Can Be Included in a Submission" [PDF]
  Huang, S-M,
  AAPS Transporter Workshop, March 8 2005, Parsippany, NJ
  
  
• "Dose dependent inhibition of midazolam elimination by ketoconazole: effect of CYP3A5 genotype" [HTML]
  A. Lucksiri A, Vuppalanchi R, Hilligoss JK, Hamman MA, Li L, Chien JY, Huang S-M, Hall SD,
  FDA Science Forum, April 26-28, 2005, Washington DC.
  
  
• "Clinical trials and drug interactions" [PDF]
  Huang S-M
  Clinical pharmacology review course at the Annual Meeting of American Society of Clinical Pharmacology and Therapeutics (ASCPT) meeting, March 6, 2005, Orlando, Florida

2004

• "FDA’s perspective on the Use of Hepatocytes in in vitro Assays to Support Regulatory Applications, Pre-meeting workshop"
  Huang, S-M
  ISSX, August 28, 2004, Vancouver, Canada
  
  
• "Update on Drug Metabolism/Drug Interaction Studies — Study Design, Data Analysis, and Implications for Dosing and Labeling" [PDF]
  Huang, S-M
  HepatocyteResearch Association Satellite Meeting to 7th ISSX August 28, 2004, Vancouver, Canada

2003

• "Gender Differences in Drug Response: Metabolism and Transport Differences- How Much Do We Know?" [PDF]
  Huang, S-M
  Sex and Rx, A Symposium on Women and Medicine, [external link] October 24, 2003, Baltimore, MD.
  
  
• "Drug interactions, or lack of drug interaction? What should we care about in terns of BA, BE, PK?"
  Huang, S-M
  Bio-International Meeting, October 7-10, 2003, London, UK
  
  
• "Effect of pharmacogenetics and drug-drug interactions on exposure-response: what needs to be done?"
  Huang, S-M
  32nd Annual meeting of American College of Clinical Pharmacology, September 21, 2003, Tampa, FL
  
  
• "Exposure-Response (E-R) Relationships- From Research to Clinic: Adjusting Dosage Regimens to Manage Risks"
  Huang, S-M
  32nd Annual meeting of American College of Clinical Pharmacology, September 21, 2003, Tampa, FL
  
  
• "Risk of drug interactions involving herbal/other products"
  Huang, S-M
  32rd Annual meeting of American College of Clinical Pharmacology, September 21, 2003, Tampa, FL
  
  
• "Risk of drug-herb and drug-citrus fruit interactions"
  Huang, S-M
  Institute of Food and Technology: Herb and grapefruit juice-drug interactions, July 12-16, 2003, Chicago, IL
  
  
• "When is drug interaction an issue? How much data do we need for an informed labeling?"
  Huang, S-M
  Drug Information Association meeting, June 16-19, 2003, San Antonio, TX.
  
  
• "The effect of pregnancy on pharmacokinetics- how much do we know?"
  Huang, S-M
  Drug Information Association meeting, June 16-19, 2003, San Antonio, TX

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Date created: October 3, 2006, Updated December 5, 2007

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