Publications by authors named "Dale Conner"

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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.
Qing Liu, Mohammad Absar, Bhawana Saluja, Changning Guo, Badrul Chowdhury, Dale P Conner

AAPS J· January 2019

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Impact of the US FDA "Biopharmaceutics Classification System" (BCS) Guidance on Global Drug Development.
Mehul U Mehta, Ramana S Uppoor, Dale P Conner, Paul Seo, Jayabharathi Vaidyanathan

Mol Pharm· December 2017

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In vitro Approaches to Support Bioequivalence and Substitutability of Generic Proton Pump Inhibitors via Nasogastric Tube Administration.
Ping Ren, Minglei Cui, Om Anand, Li Xia, Zhuojun J Zhao, Dale P Conner

AAPS J· November 2017

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Bioavailability and Bioequivalence Aspects of Oral Modified-Release Drug Products.
Rong Wang, Dale P Conner, Bing V Li

AAPS J· March 2017

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Erratum to: A Bioequivalence Approach for Generic Narrow Therapeutic Index Drugs: Evaluation of the Reference-Scaled Approach and Variability Comparison Criterion.
Wenlei Jiang, Fairouz Makhlouf, Donald J Schuirmann, Xinyuan Zhang, Nan Zheng, Dale Conner

AAPS J· November 2015

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A Bioequivalence Approach for Generic Narrow Therapeutic Index Drugs: Evaluation of the Reference-Scaled Approach and Variability Comparison Criterion.
Wenlei Jiang, Fairouz Makhlouf, Donald J Schuirmann, Xinyuan Zhang, Nan Zheng, Dale Conner

AAPS J· July 2015

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International Guidelines for Bioequivalence of Locally Acting Orally Inhaled Drug Products: Similarities and Differences.
Dongmei Lu, Sau L Lee, Robert A Lionberger, Stephanie Choi, Wallace Adams, Dale P Conner

AAPS J· May 2015

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Biopharmaceutics classification system-based biowaivers for generic oncology drug products: case studies.
Nilufer Tampal, Haritha Mandula, Hongling Zhang, Bing V Li, Hoainhon Nguyen, Dale P Conner

AAPS PharmSciTech· February 2015

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Survey of international regulatory bioequivalence recommendations for approval of generic topical dermatological drug products.
April C Braddy, Barbara M Davit, Ethan M Stier, Dale P Conner

AAPS J· January 2015

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Analysis of imprecision in incurred sample reanalysis for small molecules.
Sriram Subramaniam, Devvrat Patel, Barbara M Davit, Dale P Conner

AAPS J· January 2015

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Common bioanalytical deficiencies with bioequivalence submissions in Abbreviated New Drug Applications.
Leah N Williamson, Dale P Conner, Ethan M Stier, Barbara M Davit

Bioanalysis· February 2014

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Bioequivalence study designs for generic solid oral anticancer drug products: scientific and regulatory considerations.
Paramjeet Kaur, Chandra S Chaurasia, Barbara M Davit, Dale P Conner

J Clin Pharmacol· December 2013

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International guidelines for bioequivalence of systemically available orally administered generic drug products: a survey of similarities and differences.
Barbara Davit, April C Braddy, Dale P Conner, Lawrence X Yu

AAPS J· October 2013

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Bioequivalence for locally acting nasal spray and nasal aerosol products: standard development and generic approval.
Bing V Li, Feiyan Jin, Sau L Lee, Tao Bai, Badrul Chowdhury, Dale P Conner

AAPS J· July 2013

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Common reasons for "for-cause" inspections in bioequivalence studies submitted to the Food and Drug Administration.
Bing V Li, Barbara M Davit, Christina H Lee, Santhosh K Pabba, Chitra Mahadevan, Dale P Conner

AAPS J· January 2013

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Statistics on BCS classification of generic drug products approved between 2000 and 2011 in the USA.
Anil K Nair, Om Anand, Nam Chun, Dale P Conner, Mehul U Mehta

AAPS J· December 2012

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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.
Barbara M Davit, Mei-Ling Chen, Dale P Conner, Sam H Haidar, Stephanie Kim

AAPS J· December 2012

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Use of partial area under the curve metrics to assess bioequivalence of methylphenidate multiphasic modified release formulations.
Ethan M Stier, Barbara M Davit, Parthapratim Chandaroy, Mei-Ling Chen, Jeanne Fourie-Zirkelbach, Dale P Conner

AAPS J· December 2012

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Equivalence considerations for orally inhaled products for local action-ISAM/IPAC-RS European Workshop report.
Carole Evans, David Cipolla, Tim Chesworth, Eva Agurell, Richard Ahrens, Dale Conner

J Aerosol Med Pulm Drug Deliv· June 2012

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Common deficiencies with bioequivalence submissions in abbreviated new drug applications assessed by FDA.
Qing Liu, Barbara M Davit, Svetlana A Cherstniakova, Suman Dandamudi, Johnetta F Walters, Dale P Conner

AAPS J· March 2012

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The role of predictive biopharmaceutical modeling and simulation in drug development and regulatory evaluation.
Wenlei Jiang, Stephanie Kim, Xinyuan Zhang, Robert A Lionberger, Barbara M Davit, Dale P Conner

Int J Pharm· October 2011

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Dissolution testing for generic drugs: an FDA perspective.
Om Anand, Lawrence X Yu, Dale P Conner, Barbara M Davit

AAPS J· September 2011

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Challenges and opportunities in establishing scientific and regulatory standards for assuring therapeutic equivalence of modified release products: workshop summary report.
Mei-Ling Chen, Vinod P Shah, Derek Ganes, Kamal K Midha, James Caro, Dale Conner

AAPS J· September 2010

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Challenges and opportunities in establishing scientific and regulatory standards for determining therapeutic equivalence of modified-release products: Workshop summary report.
Mei-Ling Chen, Vinod P Shah, Derek Ganes, Kamal K Midha, James Caro, Dale Conner

Clin Ther· September 2010

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Challenges and opportunities in establishing scientific and regulatory standards for assuring therapeutic equivalence of modified-release products: workshop summary report.
Mei-Ling Chen, Vinod P Shah, Derek Ganes, Kamal K Midha, James Caro, Dale Conner

Eur J Pharm Sci· May 2010

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