Dissolution Testing for Generic Drugs: An FDA Perspective
Anand, Om, Yu, Lawrence X., Conner, Dale P., Davit, Barbara M.
Published in The AAPS journal (01.09.2011)
Published in The AAPS journal (01.09.2011)
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Comparing generic and innovator drugs: a review of 12 years of bioequivalence data from the United States Food and Drug Administration
Davit, Barbara M, Nwakama, Patrick E, Buehler, Gary J, Conner, Dale P, Haidar, Sam H, Patel, Devvrat T, Yang, Yongsheng, Yu, Lawrence X, Woodcock, Janet
Published in The Annals of pharmacotherapy (01.10.2009)
Published in The Annals of pharmacotherapy (01.10.2009)
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Scientific Considerations for the Review and Approval of First Generic Mometasone Furoate Nasal Suspension Spray in the United States from the Bioequivalence Perspective
Liu, Qing, Absar, Mohammad, Saluja, Bhawana, Guo, Changning, Chowdhury, Badrul, Lionberger, Robert, Conner, Dale P., Li, Bing V.
Published in The AAPS journal (01.03.2019)
Published in The AAPS journal (01.03.2019)
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The role of predictive biopharmaceutical modeling and simulation in drug development and regulatory evaluation
Jiang, Wenlei, Kim, Stephanie, Zhang, Xinyuan, Lionberger, Robert A., Davit, Barbara M., Conner, Dale P., Yu, Lawrence X.
Published in International journal of pharmaceutics (14.10.2011)
Published in International journal of pharmaceutics (14.10.2011)
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Implementation of a Reference-Scaled Average Bioequivalence Approach for Highly Variable Generic Drug Products by the US Food and Drug Administration
Davit, Barbara M., Chen, Mei-Ling, Conner, Dale P., Haidar, Sam H., Kim, Stephanie, Lee, Christina H., Lionberger, Robert A., Makhlouf, Fairouz T., Nwakama, Patrick E., Patel, Devvrat T., Schuirmann, Donald J., Yu, Lawrence X.
Published in The AAPS journal (01.12.2012)
Published in The AAPS journal (01.12.2012)
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Journal Article
Impact of the US FDA “Biopharmaceutics Classification System” (BCS) Guidance on Global Drug Development
Mehta, Mehul U, Uppoor, Ramana S, Conner, Dale P, Seo, Paul, Vaidyanathan, Jayabharathi, Volpe, Donna A, Stier, Ethan, Chilukuri, Dakshina, Dorantes, Angelica, Ghosh, Tapash, Mandula, Haritha, Raines, Kimberly, Dhanormchitphong, Pariban, Woodcock, Janet, Yu, Lawrence X
Published in Molecular pharmaceutics (04.12.2017)
Published in Molecular pharmaceutics (04.12.2017)
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International Guidelines for Bioequivalence of Locally Acting Orally Inhaled Drug Products: Similarities and Differences
Lu, Dongmei, Lee, Sau L., Lionberger, Robert A., Choi, Stephanie, Adams, Wallace, Caramenico, Hoainhon N., Chowdhury, Badrul A., Conner, Dale P., Katial, Rohit, Limb, Susan, Peters, John R., Yu, Lawrence, Seymour, Sally, Li, Bing V.
Published in The AAPS journal (01.05.2015)
Published in The AAPS journal (01.05.2015)
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Analysis of Imprecision in Incurred Sample Reanalysis for Small Molecules
Subramaniam, Sriram, Patel, Devvrat, Davit, Barbara M., Conner, Dale P.
Published in The AAPS journal (01.01.2015)
Published in The AAPS journal (01.01.2015)
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Journal Article
Injection molding metallic glass
Wiest, Aaron, Harmon, John S., Demetriou, Marios D., Dale Conner, R., Johnson, William L.
Published in Scripta materialia (01.02.2009)
Published in Scripta materialia (01.02.2009)
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Use of Partial Area under the Curve Metrics to Assess Bioequivalence of Methylphenidate Multiphasic Modified Release Formulations
Stier, Ethan M., Davit, Barbara M., Chandaroy, Parthapratim, Chen, Mei-Ling, Fourie-Zirkelbach, Jeanne, Jackson, Andre, Kim, Stephanie, Lionberger, Robert, Mehta, Mehul, Uppoor, Ramana S., Wang, Yaning, Yu, Lawrence, Conner, Dale P.
Published in The AAPS journal (01.12.2012)
Published in The AAPS journal (01.12.2012)
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Journal Article
Highly Variable Drugs: Observations from Bioequivalence Data Submitted to the FDA for New Generic Drug Applications
Davit, Barbara M., Conner, Dale P., Fabian-Fritsch, Beth, Haidar, Sam H., Jiang, Xiaojian, Patel, Devvrat T., Seo, Paul R. H., Suh, Keri, Thompson, Christina L., Yu, Lawrence X.
Published in The AAPS journal (2008)
Published in The AAPS journal (2008)
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Journal Article
In vitro Approaches to Support Bioequivalence and Substitutability of Generic Proton Pump Inhibitors via Nasogastric Tube Administration
Ren, Ping, Cui, Minglei, Anand, Om, Xia, Li, Zhao, Zhuojun J., Sun, Dajun, Sharp, Trueman, Conner, Dale P., Peters, John, Jiang, Wenlei, Stier, Ethan, Jiang, Xiaojian
Published in The AAPS journal (01.11.2017)
Published in The AAPS journal (01.11.2017)
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Journal Article
Statistics on BCS Classification of Generic Drug Products Approved Between 2000 and 2011 in the USA
Nair, Anil K., Anand, Om, Chun, Nam, Conner, Dale P., Mehta, Mehul U., Nhu, Duong T., Polli, James E., Yu, Lawrence X., Davit, Barbara M.
Published in The AAPS journal (01.12.2012)
Published in The AAPS journal (01.12.2012)
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