FY 2017 Generic Drug Research Public Workshop Presentations
Session I: Equivalence of complex products
- Product Characterization and In Vitro Testing for Establishing Equivalence of Complex Products, Xiaohui (Jeff) Jiang, FDA (PDF - 1.8 KB)
- Equivalence of Complex Products Cyclosporine Ophthalmic Emulsion, Robert A. Bellantone, Physical Pharmaceutica LLC (PDF - 259 KB)
- Challenges with the Demonstration of Statistical Non-Inferiority of Irritation for Transdermal Drug Delivery Systems Using the OGD Bioguidance Method, Russ Rackley, Mylan Pharmaceuticals, Inc. (PDF - 1.0 MB)
- Non-Biological Complex Drugs – Challenges for approval and post-approval standards, Jon de Vlieger, Non-Biological Complex Drugs Working Group (PDF - 600 KB)
- Gaps that remain in bioequivalence (BE) evaluation of complex drugs: how global experience with IV iron generics can inform approaches to advancing in BE guidance in the U.S., Amy Barton Pai, University of Michigan (PDF - 219 KB)
- Advanced drug product characterization techniques, Kenneth R. Morris, NIPTE and Long Island University (PDF - 1.8 KB)
- Bioequivalence (BE), Safety and Efficacy Consideration for Injectable Complex Formulations, Duxin Sun, University of Michigan (PDF - 537 KB)
Session II: Equivalence of locally-acting products
- Equivalence of Locally-Acting Drug Products, Markham C. Luke, FDA (PDF - 1.2 MB)
- Product Performance Tools for Establishing Equivalence; Combining Formulation Function with Effect, Sid Bhoopathy, Absorption Systems (PDF - 360 KB)
- Classification of topical drug products – A way forward to reducing regulatory burden, Vinod P. Shah, VPS Consulting, LLC (PDF - 315 KB)
- The Complex Biology of Vision - Equivalence Strategies for Complex Ophthalmic Products, Vatsala Naageshwaran, Absorption Systems (PDF - 1.2 MB)
Session III: Therapeutic equivalence evaluation and standards
- FDA Research Update, Myong-Jin Kim, FDA (PDF - 260 KB)
- GDUFA Amendments of 2012 Regulatory Science Initiatives: Request for Public Input for FY 2018 Generic Drug Research, Siva Vaithiyalingam, Cipla USA, Inc. (PDF - 2.7 MB)
- NIPTE Center of Excellence for Abuse Deterrent Opioid Technologies: Assessment of current and future research needs in generic drug regulation of ADF formulations, Mansoor Khan, NIPTE and Texas A&M University (PDF - 280 KB)
- IPEC-Americas recommendations for increasing collaboration and transparency with drug ingredient suppliers, David R. Schoneker, IPEC-Americas (PDF - 387 KB)
- New Scientific Directions in Oral Bioequivalence: Implications for Product Development and QC Standards (QbD, PAT), Gordon L. Amidon, University of Michigan (PDF - 1.4 MB)
- Stochastic Frameworks for Variability in Oral Dissolution-Absorption and Predictability, James G. Brasseur, University of Colorado Boulder (PDF - 774 KB)
Session IV: Computational and analytical tools
- Quantitative Methods and Modeling to Support GDUFA Regulatory Science Research Program, Liang Zhao, FDA (PDF - 1.0 MB)
- Industry Perspective on Application of Physiologically based Absorption Modeling in Generic Drug Research, Amitava Mitra, Sandoz Inc. (PDF - 1.8 KB)
- Computational modeling work in pulmonary drug targeted delivery, Yu Feng, Oklahoma State University (PDF - 1.4 MB)
- FDA Supported Grant: Pharmacokinetic and Pharmacodynamic (PK-PD) Studies of Cardiovascular Drugs, Scott Mosley, University of Florida (PDF - 41 KB)
- New Prior Knowledge as a Public Mechanism for Development and Education, Kenneth R. Morris, NIPTE and Long Island University (PDF - 183 KB)