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Drugs

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Drug Interaction Presentations

2014

 

2013

 

2012:


2011

  • Applications of Pharmacogenomics in Drug Development and Regulatory Review - Recent Relabeling of Drug Products [PDF]
    Shiew Mei Huang
    Obstetric-Fetal Pharmacology Research Units (OPRU) Network Steering Committee Meeting, Bethesda, MD, March 29, 2011 
  • Recent Advances in Transporter and CYP-based Interactions including the Interactions of Dietary Supplements and Drugs [PDF]
    Shiew Mei Huang
    OARSA Seminar, Laurel, MD, March 17, 2011 
  • Applications of Pharmacogenomics in Drug Development and Regulatory Review - Recent Relabeling of Drug Products [PDF]
    Shiew Mei Huang
    VCU AAPS Student Chapter, Richmond, VA, March 8, 2011 
  • FDA Perspective - Evaluation of Drug Interactions [PDF]
    Shiew Mei Huang
    presented at the American Society for Clinical Pharmacology & Therapeutics, Dallas, TX, March 4, 2011
     

2010
 

  • "The Role of Drug Transporters in Drug Safety-Perspective from the FDA" [PDF]
    Shiew Mei Huang
    presented at AAPS, New Orleans, LA; November 18, 2010 
  • "Scientific Perspective on Pharmacogenetic Tests Informing Clinical Decisions" [PDF]
    Shiew Mei Huang
    presented at AAPS, New Orleans, LA; November 16, 2010 
  • "A Regulatory Perspective on the Utilization of Cocktail Approach in Assessing Drug Interactions" [PDF]
    Lei Zhang
    presented at the American Association of Pharmaceutical Scientists (AAPS), New Orleans, LA; November 16, 2010 
  • "Scientific Perspectives on the Use of PBPK to Evaluate Complex Drug-Drug Interactions" [PDF]
    Ping Zhao
    presented at the AAPS, New Orleans, LA; November 15, 2010 
  • "Application of PBPK in Regulatory Review of Clinical Pharmacology Issues at FDA" [PDF]
     Ping Zhao
    presented at the American Course on Drug Development and Regulatory Sciences, Washington DC; September 23, 2010 
  • "Current Scientific Perspectives on the Use of PBPK to Predict Clinical Drug-Drug Interactions" [PDF]
    Ping Zhao
    presented at the Applied Pharmaceutical Analysis, Baltimore MD; September 22, 2010 
  • "Scientific Perspective on CYP- and Transporter- based Drug-Drug Interactions: Impact on Drug Exposure/Response, Labeling and Clinical Decisions" [PDF]
    Shiew-Mei Huang
    presented at the JSSX 25th Anniversary Symposium on October 7, 2010 at Tokyo, Japan.  
  • "Regulatory Perspective on Pharmacogenetic Tests Informing Clinical Decisions" [PDF]
    Shiew-Mei Huang
    presented at the ISSX Workshop on Genetic Polymorphisms in Drug Disposition, April 13, 2010, Indianapolis, IN. 
  • "Pharmacokinetics and Dose Adjustments in Renal Impairment" [PDF]
    Shiew-Mei Huang
    presented at the Pharmaceutical Science and Clinical Pharmacology Advisory Committee Meeting, Atlanta, GA, March 17, 2010. 
  • "Transporter-Mediated Drug-Drug Interactions (DDIs)" [PDF]
    Lei Zhang
    presented at the Pharmaceutical Science and Clinical Pharmacology Advisory Committee Meeting, Atlanta, GA, March 17, 2010. 
  • ASCPT Annual Meeting, March 17-20, 2010, Atlanta, GA
    • Drug Development and Regulatory Science (DDR)
      PIII-15
      Utility of Physiologically-Based Pharmacokinetic Modeling and Simulation In Drug Development And Challenges In Regulatory Review [PDF]
      P. Zhao, L. Zhang, L. Lesko, S. Huang; FDA, Silver Spring, MD
    • Late Breaking Poster Session II
      LBIII-2
      Utility of Integrating Prior Drug Disposition Data Into a Physiologically-Based Pharmacokinetic (PBPK) Model to Evaluate a Complex Drug-Drug Interaction: CYP/Transporter Inhibition by Ketoconazole in Subjects With Renal Impairment (RI) Taking Rivaroxaban [PDF]
      P. Zhaom J. A. Grillo, Y. Choi, B. P. Booth, N. Rahman, E. Gil Berglund, L. Zhang, L. J. Lesko, S. Huang; FDA, Silver Spring, MD, Medical Products Agency, Uppsala, Sweden 
  • "Regulatory Perspective of Modeling and Simulation Approaches to DDI Prediction" [PDF]
    Shiew-Mei Huang
    presented at the ASCPT Annual Meeting, March 18, 2010, Atlanta, GA 
  • "Scientific Perspective and Role of Drug Transporters in Drug Safety" [PDF]
    Shiew-Mei Huang
    presented at the International Conference on Drug Development University of Texas College of Pharmacy, February 24, 2010, Austin, TX
     

2009
 

  • "Drug-Drug Interactions & Adverse Drug Reactions" [PDF]
    Shiew-Mei Huang
    presented at the Joint Conference of KSCPT-ASCPT 2009, “Personalized Health Care for Global Community”, The 18th Annual Congress of the KSCPT with 2009 Autumn Conference of the Korean Society of Pharmaceutical Medicine, December 3, 2009, Seoul, Korea 
  • "Evaluation of Transporter-based Drug-Drug Interactions" [PDF]
    Shiew-Mei Huang
    presented at the AAPS Pre-Conference Workshop: "Transporter-mediated Drug-drug Interactions: Possible Criteria that Warrant In Vivo Transporter-mediated DDI Studies via In vitro Assessments", Los Angeles, CA, November 8, 2009 
  • "Drug Interactions: What Do We Know about Non-CYP Drug Metabolizing Enzymes and Transporters?" [PDF]
    Lei Zhang
    presented at the 16th ISSX North American Regional Meeting, Baltimore, MD, October 21, 2009 
  • "Evaluating Complex DDI Using Modeling And Simulations: Application and Challenge in Regulatory Review" [PDF]
    Ping Zhao
    presented at the 12th Land O’Lakes Conference on Drug Metabolism/Applied Pharmacokinetics, Merrimac, WI, September 17, 2009 
  • "Evaluation of Transporter-Mediated Drug Interactions" [PDF]
    Lei Zhang
    presented at the 12th Land O’Lakes Conference on Drug Metabolism/Applied Pharmacokinetics,  Merrimac, WI, September 16, 2009 
  • "Predicting Transporter-Mediated Drug Interactions in Humans Based on In Vitro Assessment: FDA Perspectives" [PDF]
    Lei Zhang
    presented at the AAPS Workshop: Evolving Science and Technology in Physical Pharmacy and Biopharmaceutics, May 13, 2009, Baltimore, MD. 
  • "Where Are We in the Evaluation and Labeling of Transporters & Drug-Drug Interactions?-FDA perspective" [PDF]
    Shiew-Mei Huang
    AAPS From Bench to Bedside Transporter Workshop, March 31, 2009, Baltimore, MD 
  • "Possible Criteria that Warrant In Vivo P-Glycoprotein-Mediated Drug Interaction Studies Based on In Vitro Assessment" [PDF]
    Lei Zhang
    "AAPS From Bench to Bedside Transporter Workshop, March 31, 2009, Baltimore, MD 
  • "Transporters and Pediatrics" [PDF]
    Gilbert Burckart
    AAPS From Bench to Bedside Transporter Workshop, March 31, 2009, Baltimore, MD


2008

 

  • "Challenges in the Evaluation and Labeling of Drug-Drug Interactions - Focusing on Transporters - presented at the AAPS (American Association of Pharmaceutical Scientists) Annual Meeting, workshop on "Why Absorption and Pharmacokinetic Models Are More Important in Future Drug Development" [PDF]
    Huang, S-M
    November 17, 2008, Atlanta, GA 
  • "Drug Interactions and Labeling - Issues Beyond the Font Size" [PDF]
    Huang, S-M
    9th International Workshop, Clinical Pharmacology of HIV Therapy, April 8, 2008, New Orleans, LA 
  • "Drug Transporters and Phase 2 Metabolizing Enzymes and Their Role in Drug Interactions- Risk Assessment in Drug Development and Implications for Dosing and Labeling" [PDF]
    Shiew-Mei Huang,
    presented at one of the symposium entitled "Drug-Drug Interactions- Looking Beyond Cytochrome P450 Inhibition" at the 2008 ASCPT annual meeting in Orlando, FL, April 3, 2008 
  • "Evaluation and Labeling of Drug-Drug Interactions - Focusing on Transporters" [PDF]
    Huang, S-M
    FDA Critical Path Transporter Workshop, October 3, 2008 
  • "When to Conduct a Renal Impairment Study" [PDF]
    Huang, S-M
    Clinical Pharmacology Advisory Committee Meeting, March 19, 2008, Rockville, MD


2007

 

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


2006

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