GDUFA Research Outcomes

Other Generics Research

This section contains scientific publications, presentations, and posters arising from GDUFA-funded research relevant to other research relevant to generic products.

• All(113)
• Posters(9)
• Presentations(91)
• Papers(13)

• Generic Drugs: Expanding Possibilities for Clinical Pharmacology

  Uhl, Kathleen

• In Vitro Biopredictive Methods: A Workshop Summary Report

  Pepin, Xavier; Dressman, Jennifer; Parrott, Neil; Delvadia, Poonam; Mitra, Amitava; Zhang, Xinyuan; Babiskin, Andrew; Kolhatkat, Vidula; Seo, Paul; Taylor, Lynne; Sjogren, Erik; Butler, James; Kostewicz, Edmund; Tannergren, Christer; Koziolek, Mirko; Kesisoglou, Filippos; Dallmann, Andre; Zhao, Yang; Suarez-Sharp, Sandra

• Decision Science for Generic Drug Development and Review

  Lionberger, Robert

• Best Practices in the Development and Validation of Physiologically Based Biopharmaceutics Modeling. A Workshop Summary Report

  Parrott, Neil; Suarez Sharp, Sandra; Kesisoglou, Filippos; Pathak, Shriram; Good, David; Wagner, Christian; Dallmann, Andre; Mullin, James; Patel, Nikunjkumar; Riedmaier, Arian; Mitra, Amitava; Raines, Kimberly; Butler, James; Kakhi, Maziar; Li, Min; Zhao, Yang; Tsakalozou, Eleftheria; Flanagan, Talia; Dressman, Jennifer; Pepin, Xavier

• The global bioequivalence harmonisation initiative: Report of EUFEPS/AAPS third conference

  Mehta, Mehul; Blume, Henning; Beuerle, Gerald; Tampal, Nilufer; Schug, Barbara; Potthast, Henrike; Jiang, Wenlei; Wilson, Clive

• Regulation and Innovation: Role of Regulatory Science in Facilitating Pharmaceutical Innovation

  Zhang, Lei

• Clinical Pharmacology in Women’s Health: Current Status and Opportunities

  Jarugula, Venkateswar

• FDA Critical Path Initiatives: Opportunities for Generic Drug Development

  Lionberger, Robert

• Applications of Clinically Relevant Dissolution Testing: Workshop Summary Report

  Suarez Sharp, Sandra; Cohen, Michael; Kesisoglou, Filippos; Abend, Andreas; Marroum, Patrick; Delvadia, Poonam; Kotzagiorgis, Evangelos; Li, Min; Nordmark, Anna; Bandi, Nagesh; Sjogren, Erik; Babiskin, Andrew; Heimbach, Tycho; Kijima, Shinichi; Mandula, H

• Generics 2030: Where are We Heading in 2030 for Generic Drug Science, Research, and Regulation?

  Lionberger, Robert