• GDUFA Regulatory Science Update (PDF - 2517KB)
  Robert Lionberger, FDA
• Regulatory Science For Generic Drugs (PDF - 146KB)
  Michael Fischer, Brigham & Women’s Hospital
• Regulatory Product Research: Oral Systemic Drug Products (PDF - 1590B)
  Gordon L. Amidon, University of Michigan
• Potential New Method To Improve BE Of Modified Release (MR) Drug Products By In Vivo Dissolution Studies In Human GI Tract (PDF - 780KB)
  Duxin Sun, University of Michigan
• Non-Biological Complex Drugs: Challenges In The Assessment Of Similarity Or Equivalence Of Ophthalmic Emulsions (PDF - 415KB)
  Chetan Pujara, Allergan
• Issues Associated With Generic Drugs Used In Children (PDF - 504KB)
  Catherine M.T. Sherwin, University of Utah School of Medicine
• Confidence In Generics: Need for An Integrated Approach To Formulation Research & Knowledge Management (PDF - 2360KB)
  Ajaz S. Hussain, National Institute for Pharmaceutical Technology and Education (NIPTE)
• Mechanism For An Integrated Approach To Formulation Research, Knowledge Management, & Knowledge Sharing With FDA & Industry (PDF - 504KB)
  Stephen R. Byrn, National Institute for Pharmaceutical Technology and Education (NIPTE) and Purdue University
• Integrated Approach For Evolving Standards For Formulation Design – Case Example NTI’s (PDF - 634KB)
  Kenneth R. Morris, National Institute for Pharmaceutical Technology and Education (NIPTE) and Long Island University
• Integrated Approach For Evolving Standard For Analytical Characterization – Case Example Excipient Variability (PDF - 1481KB)
  Eric J. Munson, National Institute for Pharmaceutical Technology and Education (NIPTE) and University of Kentucky
• Relevant Challenges In Determination Of Bioequivalence Of Generic IV Iron Formulations (PDF - 613KB)
  Amy Barton Pai, Albany College of Pharmacy and Health Sciences
• In Vitro In Vivo Correlation for Complex Drug Products And In Vitro/In Vivo Stability Issues (PDF - 5642KB)
  Diane J. Burgess, University of Connecticut
• FY 2017 Regulatory Science Priorities GPhA’s Perspective (PDF - 345KB)
  David Gaugh, Generic Pharmaceutical Association (GPhA)
• PBPK Modelling In Generic Product Assessment (PDF - 1826KB)
  Nikunjkumar Patel, Simcyp(a Certara Company)
• Challenges With The Demonstration Of Statistical Non-Inferiority Of Adhesion & Irritation For Transdermal Drug Delivery Systems Using The OGD Bioguidance Method (PDF - 1112KB)
  Russ Rackley, Mylan Inc.
• The Need For Science & Risk-Based Excipient Safety Assessment During Generic Drug Review – Impact On Formulation Quality & Performance (PDF - 434KB)
  David R. Schoneker, Colorcon
• Reconstruction Of The Airway Tree, Airflow & Drug Delivery Calculations In The Lungs Of Children With Disease (PDF - 782KB)
  Bahman Asgharian, Applied Research Associates, Inc.
• Protecting The Public Health Through Improved Generic Drug Regulation (PDF - 390KB)
  Tracy Rupp, National Center for Health Research
• Importance & Modeling Of Hydrodynamic Effects In Dissolution & Absorption In Vivo vs. In Vitro (PDF - 1256KB)
  James G. Brasseur, University of Colorado & Pennsylvania State University
• Considerations In Excipients (PDF - 418KB)
  James E. Polli, University of Maryland  School of Pharmacy

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 Return to: FY 2016 Regulatory Science Initiatives Part 15 Public Meeting