Barbara M Davit
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Explore the profile of Barbara M Davit including associated specialties, affiliations and a list of published articles.
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Articles
21
Citations
358
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Recent Articles
1.
Davit B, Kanfer I, Tsang Y, Cardot J
AAPS J
. 2016 Mar;
18(3):612-8.
PMID: 26943914
The Biopharmaceutics Classification System (BCS), based on aqueous solubility and intestinal permeability, has enjoyed wide use since 1995 as a mechanism for waiving in vivo bioavailability and bioequivalence studies. In...
2.
Subramaniam S, Stier E, Davit B
Bioanalysis
. 2014 Dec;
6(24):3349-54.
PMID: 25534791
No abstract available.
3.
Subramaniam S, Patel D, Davit B, Conner D
AAPS J
. 2014 Oct;
17(1):206-15.
PMID: 25354732
Over the years, incurred sample (IS) reanalysis (ISR) has become a tool to confirm the reliability of bioanalytical measurements. The recommendation for ISR acceptance criterion for small molecules is at...
4.
Braddy A, Davit B, Stier E, Conner D
AAPS J
. 2014 Oct;
17(1):121-33.
PMID: 25344440
The objective of this article is to discuss the similarities and differences in accepted bioequivalence (BE) approaches for generic topical dermatological drug products between international regulatory authorities and organizations. These...
5.
Williamson L, Conner D, Stier E, Davit B
Bioanalysis
. 2014 Feb;
6(4):441-5.
PMID: 24568348
Background: The US FDA published A Guidance for Industry: Bioanalytical Method Validation in May 2001. Despite the publication of the guidance, companies continue to submit bioequivalence studies with bioanalytical deficiencies...
6.
Kaur P, Chaurasia C, Davit B, Conner D
J Clin Pharmacol
. 2013 Sep;
53(12):1252-60.
PMID: 23996908
The demonstration of bioequivalence (BE) between the test and reference products is an integral part of generic drug approval process. A sound BE study design is pivotal to the successful...
7.
Li B, Davit B, Lee C, Pabba S, Mahadevan C, Caramenico H, et al.
AAPS J
. 2012 Oct;
15(1):10-4.
PMID: 23054974
"For-cause" inspections are initiated during the review of bioequivalence (BE) data submitted to Abbreviated New Drug Applications when possible scientific misconduct and study irregularities are discovered. We investigated the common...
8.
Stier E, Davit B, Chandaroy P, Chen M, Fourie-Zirkelbach J, Jackson A, et al.
AAPS J
. 2012 Sep;
14(4):925-6.
PMID: 22976173
No abstract available.
9.
Davit B, Chen M, Conner D, Haidar S, Kim S, Lee C, et al.
AAPS J
. 2012 Sep;
14(4):915-24.
PMID: 22972221
Highly variable (HV) drugs are defined as those for which within-subject variability (%CV) in bioequivalence (BE) measures is 30% or greater. Because of this high variability, studies designed to show...
10.
Mirza T, Bykadi S, Ellison C, Yang Y, Davit B, Khan M
Pharm Res
. 2012 Aug;
30(1):179-90.
PMID: 22910891
Purpose: To determine if an IVIVC model can predict PK profiles of varying formulations of a BCS Class 1 drug that is a salt of a weak base. Method: An...