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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 PerspectiveNARA Subscribed
The AAPS Journal · 2019 · Vol. 21 · Issue 2 · Springer
Qing Liu; Mohammad Absar; Bhawana Saluja; Changning Guo; Badrul Chowdhury; Robert Lionberger; Dale P. Conner; Bing V. Li
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In vitro Approaches to Support Bioequivalence and Substitutability of Generic Proton Pump Inhibitors via Nasogastric Tube AdministrationNARA Subscribed
The AAPS Journal · 2017 · Vol. 19 · Issue 6 · Springer
Ping Ren; Minglei Cui; Om Anand; Li Xia; Zhuojun J. Zhao; Dajun Sun; Trueman Sharp; Dale P. Conner; John Peters; Wenlei Jiang; Ethan Stier; Xiaojian Jiang
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Bioavailability and Bioequivalence Aspects of Oral Modified-Release Drug ProductsNARA Subscribed
The AAPS Journal · 2017 · Vol. 19 · Issue 2 · Springer
Rong Wang; Dale P. Conner; Bing V. Li
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Erratum to: A Bioequivalence Approach for Generic Narrow Therapeutic Index Drugs: Evaluation of the Reference-Scaled Approach and Variability Comparison CriterionNARA Subscribed
The AAPS Journal · 2015 · Vol. 17 · Issue 6 · Springer
Wenlei Jiang; Fairouz Makhlouf; Donald J. Schuirmann; Xinyuan Zhang; Nan Zheng; Dale Conner; Lawrence X. Yu; Robert Lionberger
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A Bioequivalence Approach for Generic Narrow Therapeutic Index Drugs: Evaluation of the Reference-Scaled Approach and Variability Comparison CriterionNARA Subscribed
The AAPS Journal · 2015 · Vol. 17 · Issue 4 · Springer
Wenlei Jiang; Fairouz Makhlouf; Donald J. Schuirmann; Xinyuan Zhang; Nan Zheng; Dale Conner; Lawrence X. Yu; Robert Lionberger
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International Guidelines for Bioequivalence of Locally Acting Orally Inhaled Drug Products: Similarities and DifferencesNARA Subscribed
The AAPS Journal · 2015 · Vol. 17 · Issue 3 · Springer
Dongmei Lu; Sau L. Lee; Robert A. Lionberger; Stephanie Choi; Wallace Adams; Hoainhon N. Caramenico; Badrul A. Chowdhury; Dale P. Conner; Rohit Katial; Susan Limb; John R. Peters; Lawrence Yu; Sally Seymour; Bing V. Li
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Biopharmaceutics Classification System-Based Biowaivers for Generic Oncology Drug Products: Case StudiesNARA Subscribed
AAPS PharmSciTech · 2015 · Vol. 16 · Issue 1 · Springer
Nilufer Tampal; Haritha Mandula; Hongling Zhang; Bing V. Li; Hoainhon Nguyen; Dale P. Conner
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Analysis of Imprecision in Incurred Sample Reanalysis for Small MoleculesNARA Subscribed
The AAPS Journal · 2015 · Vol. 17 · Issue 1 · Springer
Sriram Subramaniam; Devvrat Patel; Barbara M. Davit; Dale P. Conner
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Survey of International Regulatory Bioequivalence Recommendations for Approval of Generic Topical Dermatological Drug ProductsNARA Subscribed
The AAPS Journal · 2015 · Vol. 17 · Issue 1 · Springer
April C. Braddy; Barbara M. Davit; Ethan M. Stier; Dale P. Conner
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International Guidelines for Bioequivalence of Systemically Available Orally Administered Generic Drug Products: A Survey of Similarities and DifferencesNARA Subscribed
The AAPS Journal · 2013 · Vol. 15 · Issue 4 · Springer
Barbara Davit; April C. Braddy; Dale P. Conner; Lawrence X. Yu
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Bioequivalence for Locally Acting Nasal Spray and Nasal Aerosol Products: Standard Development and Generic ApprovalNARA Subscribed
The AAPS Journal · 2013 · Vol. 15 · Issue 3 · Springer
Bing V. Li; Feiyan Jin; Sau L. Lee; Tao Bai; Badrul Chowdhury; Hoainhon T. Caramenico; Dale P. Conner
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Common Reasons for “For-Cause” Inspections in Bioequivalence Studies Submitted to the Food and Drug AdministrationNARA Subscribed
The AAPS Journal · 2013 · Vol. 15 · Issue 1 · Springer
Bing V. Li; Barbara M. Davit; Christina H. Lee; Santhosh K. Pabba; Chitra Mahadevan; Hoainhon T. Caramenico; Sam H Haidar; Aida L. Sanchez; Aaron W. Sigler; Ethan M. Stier; Dale P. Conner
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Use of Partial Area under the Curve Metrics to Assess Bioequivalence of Methylphenidate Multiphasic Modified Release FormulationsNARA Subscribed
The AAPS Journal · 2012 · Vol. 14 · Issue 4 · Springer
Ethan M. Stier; Barbara M. Davit; Parthapratim Chandaroy; Mei-Ling Chen; Jeanne Fourie-Zirkelbach; Andre Jackson; Stephanie Kim; Robert Lionberger; Mehul Mehta; Ramana S. Uppoor; Yaning Wang; Lawrence Yu; Dale P. Conner
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Implementation of a Reference-Scaled Average Bioequivalence Approach for Highly Variable Generic Drug Products by the US Food and Drug AdministrationNARA Subscribed
The AAPS Journal · 2012 · Vol. 14 · Issue 4 · Springer
Barbara M. Davit; Mei-Ling Chen; Dale P. Conner; Sam H. Haidar; Stephanie Kim; Christina H. Lee; Robert A. Lionberger; Fairouz T. Makhlouf; Patrick E. Nwakama; Devvrat T. Patel; Donald J. Schuirmann; Lawrence X. Yu
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Statistics on BCS Classification of Generic Drug Products Approved Between 2000 and 2011 in the USANARA Subscribed
The AAPS Journal · 2012 · Vol. 14 · Issue 4 · Springer
Anil K. Nair; Om Anand; Nam Chun; Dale P. Conner; Mehul U. Mehta; Duong T. Nhu; James E. Polli; Lawrence X. Yu; Barbara M. Davit
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Common Deficiencies with Bioequivalence Submissions in Abbreviated New Drug Applications Assessed by FDANARA Subscribed
The AAPS Journal · 2012 · Vol. 14 · Issue 1 · Springer
Qing Liu; Barbara M. Davit; Svetlana A. Cherstniakova; Suman Dandamudi; Johnetta F. Walters; Christina H. Lee; Kimberly W. Raines; Ke Ren; Leeh N. Williamson; Dale P. Conner
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Dissolution Testing for Generic Drugs: An FDA PerspectiveNARA Subscribed
The AAPS Journal · 2011 · Vol. 13 · Issue 3 · Springer
Om Anand; Lawrence X. Yu; Dale P. Conner; Barbara M. Davit
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Challenges and Opportunities in Establishing Scientific and Regulatory Standards for Assuring Therapeutic Equivalence of Modified Release Products: Workshop Summary ReportNARA Subscribed
The AAPS Journal · 2010 · Vol. 12 · Issue 3 · Springer
Mei-Ling Chen; Vinod P. Shah; Derek Ganes; Kamal K. Midha; James Caro; Prabu Nambiar; Mario L. Rocci; Avinash G. Thombre; Bertil Abrahamsson; Dale Conner; Barbara Davit; Paul Fackler; Colm Farrell; Suneel Gupta; Russell Katz; Mehul Mehta; Sheldon H. Preskorn; Gerard Sanderink; Salomon Stavchansky; Robert Temple; Yaning Wang; Helen Winkle; Lawrence Yu
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In Vitro Considerations to Support Bioequivalence of Locally Acting Drugs in Dry Powder Inhalers for Lung DiseasesNARA Subscribed
The AAPS Journal · 2009 · Vol. 11 · Issue 3 · Springer
Sau Lawrence Lee; Wallace P. Adams; Bing V. Li; Dale P. Conner; Badrul A. Chowdhury; Lawrence X. Yu
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Evaluation of a Scaling Approach for the Bioequivalence of Highly Variable DrugsNARA Subscribed
The AAPS Journal · 2008 · Vol. 10 · Issue 3 · Springer
Sam H. Haidar; Fairouz Makhlouf; Donald J. Schuirmann; Terry Hyslop; Barbara Davit; Dale Conner; Lawrence X. Yu
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Evaluation of a Scaling Approach for the Bioequivalence of Highly Variable DrugsNARA Subscribed
The AAPS Journal · 2008 · Vol. 10 · Issue 3 · Springer
Sam H. Haidar; Fairouz Makhlouf; Donald J. Schuirmann; Terry Hyslop; Barbara Davit; Dale Conner; Lawrence X. Yu
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Highly Variable Drugs: Observations from Bioequivalence Data Submitted to the FDA for New Generic Drug ApplicationsNARA Subscribed
The AAPS Journal · 2008 · Vol. 10 · Issue 1 · Springer
Barbara M. Davit; Dale P. Conner; Beth Fabian-Fritsch; Sam H. Haidar; Xiaojian Jiang; Devvrat T. Patel; Paul R. H. Seo; Keri Suh; Christina L. Thompson; Lawrence X. Yu
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Bioequivalence Approaches for Highly Variable Drugs and Drug ProductsNARA Subscribed
Pharmaceutical Research · 2008 · Vol. 25 · Issue 1 · Springer
Sam H. Haidar; Barbara Davit; Mei-Ling Chen; Dale Conner; LaiMing Lee; Qian H. Li; Robert Lionberger; Fairouz Makhlouf; Devvrat Patel; Donald J. Schuirmann; Lawrence X. Yu
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Biopharmaceutics Classification System: The Scientific Basis for Biowaiver ExtensionsNARA Subscribed
Pharmaceutical Research · 2002 · Vol. 19 · Issue 7 · Springer
Lawrence X. Yu; Gordon L. Amidon; James E. Polli; Hong Zhao; Mehul U. Mehta; Dale P. Conner; Vinod P. Shah; Lawrence J. Lesko; Mei-Ling Chen; Vincent H. L. Lee; Ajaz S. Hussain
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Bioavailability and Bioequivalence: An FDA Regulatory OverviewNARA Subscribed
Pharmaceutical Research · 2001 · Vol. 18 · Issue 12 · Springer
Mei-Ling Chen; Vinod Shah; Rabindra Patnaik; Wallace Adams; Ajaz Hussain; Dale Conner; Mehul Mehta; Henry Malinowski; John Lazor; Shiew-Mei Huang; Don Hare; Lawrence Lesko; Douglas Sporn; Roger Williams
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