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FY 2014 Regulatory Science Initiatives Part 15 Public Meeting Presentations

 

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Find the presentations below on an archived version of this webpage 

  • FY 2014 Regulatory Science Initiatives Part 15 Public Meeting
  • GDUFA Regulatory Science Update
  • FY 2015 Regulatory Science Priorities
  • Tackling Generic Drug Safety
  • €œManagement of Device Changes Through the Product Lifecycle
  • Why Clinically Appropriate In Vitro Inhaler Testing? – Introducing the Patient Experience into the Picture
  • €œResearch Opportunities in Evaluating Abuse Deterrent Opioid Formulations
  • €œImpact of Formulation and Process Variations on the Quality of Freeze Dried Products: How do we identify, control, and characterize critical variations?
  • Raw Material and Manufacturing Factors Affecting the Quality of Generic Pharmaceutical Products
  • Expanding BCS-Based Biowaivers
  • The New Science of (Oral) Bioequivalence: In Vivo Predictive Dissolution (IPD)
  • Biopharmaceutics Risk of Orally-Administered Products
  • Direct Measurement and Computational Modeling of In Vivo Drug Dissolution in Human GI tract for Accurate BA/BE Study and Prediction of Generic Drugs
  • Use of Microdialysis for the Evaluation of Topical Bioequivalence
  • Non-Clinical Tools for Performance Testing of Complex Drug Products
  • Challenges for Non-Biological Complex Drugs (NBCDs)
  • €œApproval Standards of Follow-on Versions of IV Nanocolloidal Iron-based Medicinal Products (NBCDs)
  • Nanosimilars
  • €œA NanoSensor for Detecting PPB Levels of OverSulfated Chondroitin Sulfate in Unfractionated Heparin
  • Importance of Regulatory Research Funding for Long Acting Release (LAR) Drug Products
  • €œIntravitreal Sustained Release Ganciclovir: An Orphan Generic
  • Developing, Implementing, and Validating Reliable Methods for BU Testing
Persons with disabilities having problems accessing this page may call (301) 796-3634 for assistance.
 
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