GDUFA Research Outcomes
Other Generics Resaerch
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Generic Drugs: Expanding Possibilities for Clinical Pharmacology
Uhl, Kathleen
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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
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Decision Science for Generic Drug Development and Review
Lionberger, Robert
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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
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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
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Regulation and Innovation: Role of Regulatory Science in Facilitating Pharmaceutical Innovation
Zhang, Lei
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Clinical Pharmacology in Women’s Health: Current Status and Opportunities
Jarugula, Venkateswar
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FDA Critical Path Initiatives: Opportunities for Generic Drug Development
Lionberger, Robert
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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
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Generics 2030: Where are We Heading in 2030 for Generic Drug Science, Research, and Regulation?
Lionberger, Robert