Publications by authors named "Barbara Davit"

Claim this Profile
F
Food effects in paediatric medicines development for products Co-administered with food.
Hannah Batchelor, Ann Marie Kaukonen, Sandra Klein, Barbara Davit, Rob Ju

Int J Pharm· February 2018

Social Media Activity not collected for this article yet.

Sign Up to Request Social Media Analysis
T
The Global Bioequivalence Harmonization Initiative: Summary report for EUFEPS international conference.
Mei-Ling Chen, Henning Blume, Gerald Beuerle, Barbara Davit, Mehul Mehta

Eur J Pharm Sci· January 2018

Social Media Activity not collected for this article yet.

Sign Up to Request Social Media Analysis
B
BCS Biowaivers: Similarities and Differences Among EMA, FDA, and WHO Requirements.
Barbara M Davit, Isadore Kanfer, Yu Chung Tsang, Jean-Michel Cardot

AAPS J· May 2016

Social Media Activity not collected for this article yet.

Sign Up to Request Social Media Analysis
A
Assessing bioequivalence of generic modified-release antiepileptic drugs.
Emily L Johnson, Yi-Ting Chang, Barbara Davit, Barry E Gidal, Gregory L Krauss

Neurology· April 2016

Social Media Activity not collected for this article yet.

Sign Up to Request Social Media Analysis
I
Incurred sample reanalysis in bioequivalence studies for abbreviated new drug applications.
Sriram Subramaniam, Ethan Stier, Barbara M Davit

Bioanalysis· August 2015

Social Media Activity not collected for this article yet.

Sign Up to Request Social Media Analysis
S
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

Social Media Activity not collected for this article yet.

Sign Up to Request Social Media Analysis
A
Analysis of imprecision in incurred sample reanalysis for small molecules.
Sriram Subramaniam, Devvrat Patel, Barbara M Davit, Dale P Conner

AAPS J· January 2015

Social Media Activity not collected for this article yet.

Sign Up to Request Social Media Analysis
C
Current challenges in bioequivalence, quality, and novel assessment technologies for topical products.
Avraham Yacobi, Vinod P Shah, Edward D Bashaw, Eva Benfeldt, Barbara Davit

Pharm Res· April 2014

Social Media Activity not collected for this article yet.

Sign Up to Request Social Media Analysis
C
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

Social Media Activity not collected for this article yet.

Sign Up to Request Social Media Analysis
B
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

Social Media Activity not collected for this article yet.

Sign Up to Request Social Media Analysis
I
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

Social Media Activity not collected for this article yet.

Sign Up to Request Social Media Analysis
U
Use of in vitro-in vivo correlation to predict the pharmacokinetics of several products containing a BCS class 1 drug in extended release matrices.
Tahseen Mirza, Srikant A Bykadi, Christopher D Ellison, Yongsheng Yang, Barbara M Davit

Pharm Res· January 2013

Social Media Activity not collected for this article yet.

Sign Up to Request Social Media Analysis
C
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

AAPS J· January 2013

Social Media Activity not collected for this article yet.

Sign Up to Request Social Media Analysis
S
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, Barbara M Davit

AAPS J· December 2012

Social Media Activity not collected for this article yet.

Sign Up to Request Social Media Analysis
I
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

Social Media Activity not collected for this article yet.

Sign Up to Request Social Media Analysis
U
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

AAPS J· December 2012

Social Media Activity not collected for this article yet.

Sign Up to Request Social Media Analysis
S
Summary workshop report: Facilitating oral product development and reducing regulatory burden through novel approaches to assess bioavailability/bioequivalence.
James E Polli, Jack A Cook, Barbara M Davit, Paul A Dickinson, Domenick Argenti

AAPS J· September 2012

Social Media Activity not collected for this article yet.

Sign Up to Request Social Media Analysis
C
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

AAPS J· March 2012

Social Media Activity not collected for this article yet.

Sign Up to Request Social Media Analysis
T
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

Int J Pharm· October 2011

Social Media Activity not collected for this article yet.

Sign Up to Request Social Media Analysis
D
Dissolution testing for generic drugs: an FDA perspective.
Om Anand, Lawrence X Yu, Dale P Conner, Barbara M Davit

AAPS J· September 2011

Social Media Activity not collected for this article yet.

Sign Up to Request Social Media Analysis
U
Using partial area for evaluation of bioavailability and bioequivalence.
Mei-Ling Chen, Barbara Davit, Robert Lionberger, Zakaria Wahba, Hae-Young Ahn

Pharm Res· August 2011

Social Media Activity not collected for this article yet.

Sign Up to Request Social Media Analysis
U
Utility of physiologically based absorption modeling in implementing Quality by Design in drug development.
Xinyuan Zhang, Robert A Lionberger, Barbara M Davit, Lawrence X Yu

AAPS J· March 2011

Social Media Activity not collected for this article yet.

Sign Up to Request Social Media Analysis
I
Impact of Biopharmaceutics Classification System-based biowaivers.
Jack A Cook, Barbara M Davit, James E Polli

Mol Pharm· October 2010

Social Media Activity not collected for this article yet.

Sign Up to Request Social Media Analysis
C
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, Barbara Davit

AAPS J· September 2010

Social Media Activity not collected for this article yet.

Sign Up to Request Social Media Analysis
C
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, Barbara Davit

Clin Ther· September 2010

Social Media Activity not collected for this article yet.

Sign Up to Request Social Media Analysis