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The “Coptic” textiles of the “Museo Egizio” in Torino (Italy): a focus on dyes through a multi-technique approachNARA Subscribed
Archaeological and Anthropological Sciences · 2017 · Vol. 9 · Issue 4 · Springer
Monica Gulmini; A. Idone; P. Davit; M. Moi; M. Carrillo; C. Ricci; F. Dal Bello; M. Borla; C. Oliva; C. Greco; M. Aceto
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Implementing the Biopharmaceutics Classification System in Drug Development: Reconciling Similarities, Differences, and Shared Challenges in the EMA and US-FDA-Recommended ApproachesNARA Subscribed
The AAPS Journal · 2016 · Vol. 18 · Issue 4 · Springer
J.-M. Cardot; A. Garcia Arieta; P. Paixao; I. Tasevska; B. Davit
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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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Current Challenges in Bioequivalence, Quality, and Novel Assessment Technologies for Topical ProductsNARA Subscribed
Pharmaceutical Research · 2014 · Vol. 31 · Issue 4 · Springer
Avraham Yacobi; Vinod P. Shah; Edward D. Bashaw; Eva Benfeldt; Barbara Davit; Derek Ganes; Tapash Ghosh; Isadore Kanfer; Gerald B. Kasting; Lindsey Katz; Robert Lionberger; Guang Wei Lu; Howard I. Maibach; Lynn K. Pershing; Russell J. Rackley; Andre Raw; Chinmay G. Shukla; Kailas Thakker; Nathalie Wagner; Elizabeta Zovko; Majella E. Lane
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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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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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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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