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; Robert Lionberger; Dale P. Conner; Bing V. Li (The AAPS Journal, 2019)

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; Dajun Sun; Trueman Sharp; Dale P. Conner; John Peters; Wenlei Jiang; Ethan Stier; Xiaojian Jiang (The AAPS Journal, 2017)

Bioavailability and Bioequivalence Aspects of Oral Modified-Release Drug Products - Rong Wang; Dale P. Conner; Bing V. Li (The AAPS Journal, 2017)

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; Lawrence X. Yu; Robert Lionberger (The AAPS Journal, 2015)

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; Lawrence X. Yu; Robert Lionberger (The AAPS Journal, 2015)

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; Hoainhon N. Caramenico; Badrul A. Chowdhury; Dale P. Conner; Rohit Katial; Susan Limb; John R. Peters; Lawrence Yu; et al. (The AAPS Journal, 2015)

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, 2015)

Analysis of Imprecision in Incurred Sample Reanalysis for Small Molecules - Sriram Subramaniam; Devvrat Patel; Barbara M. Davit; Dale P. Conner (The AAPS Journal, 2015)

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 (The AAPS Journal, 2015)

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 (The AAPS Journal, 2013)

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; Hoainhon T. Caramenico; Dale P. Conner (The AAPS Journal, 2013)

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; Hoainhon T. Caramenico; Sam H Haidar; Aida L. Sanchez; Aaron W. Sigler; Ethan M. Stier; Dale P. Conner (The AAPS Journal, 2013)

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; Andre Jackson; Stephanie Kim; Robert Lionberger; Mehul Mehta; Ramana S. Uppoor; Yaning Wang; Lawrence Yu; et al. (The AAPS Journal, 2012)

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; Christina H. Lee; Robert A. Lionberger; Fairouz T. Makhlouf; Patrick E. Nwakama; Devvrat T. Patel; Donald J. Schuirmann; Lawrence X. Yu (The AAPS Journal, 2012)

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; Duong T. Nhu; James E. Polli; Lawrence X. Yu; Barbara M. Davit (The AAPS Journal, 2012)

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; Christina H. Lee; Kimberly W. Raines; Ke Ren; Leeh N. Williamson; Dale P. Conner (The AAPS Journal, 2012)

Dissolution Testing for Generic Drugs: An FDA Perspective - Om Anand; Lawrence X. Yu; Dale P. Conner; Barbara M. Davit (The AAPS Journal, 2011)

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; Prabu Nambiar; Mario L. Rocci; Avinash G. Thombre; Bertil Abrahamsson; Dale Conner; Barbara Davit; Paul Fackler; et al. (The AAPS Journal, 2010)

In Vitro Considerations to Support Bioequivalence of Locally Acting Drugs in Dry Powder Inhalers for Lung Diseases - Sau Lawrence Lee; Wallace P. Adams; Bing V. Li; Dale P. Conner; Badrul A. Chowdhury; Lawrence X. Yu (The AAPS Journal, 2009)

Evaluation of a Scaling Approach for the Bioequivalence of Highly Variable Drugs - Sam H. Haidar; Fairouz Makhlouf; Donald J. Schuirmann; Terry Hyslop; Barbara Davit; Dale Conner; Lawrence X. Yu (The AAPS Journal, 2008)

Evaluation of a Scaling Approach for the Bioequivalence of Highly Variable Drugs - Sam H. Haidar; Fairouz Makhlouf; Donald J. Schuirmann; Terry Hyslop; Barbara Davit; Dale Conner; Lawrence X. Yu (The AAPS Journal, 2008)

Highly Variable Drugs: Observations from Bioequivalence Data Submitted to the FDA for New Generic Drug Applications - 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 (The AAPS Journal, 2008)

Bioequivalence Approaches for Highly Variable Drugs and Drug Products - 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 (Pharmaceutical Research, 2008)

Biopharmaceutics Classification System: The Scientific Basis for Biowaiver Extensions - 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 (Pharmaceutical Research, 2002)

Bioavailability and Bioequivalence: An FDA Regulatory Overview - 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; et al. (Pharmaceutical Research, 2001)