Dale P Conner
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Explore the profile of Dale P Conner including associated specialties, affiliations and a list of published articles.
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Articles
28
Citations
492
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Recent Articles
1.
Liu Q, Absar M, Saluja B, Guo C, Chowdhury B, Lionberger R, et al.
AAPS J
. 2019 Jan;
21(2):14.
PMID: 30617594
In 2016, the US Food and Drug Administration (FDA) approved the first Abbreviated New Drug Application for Mometasone Furoate Nasal Suspension Spray. To establish the bioequivalence of this generic nasal...
2.
Mehta M, Uppoor R, Conner D, Seo P, Vaidyanathan J, Volpe D, et al.
Mol Pharm
. 2017 Oct;
14(12):4334-4338.
PMID: 29076742
The FDA guidance on application of the biopharmaceutics classification system (BCS) for waiver of in vivo bioequivalence (BE) studies was issued in August 2000. Since then, this guidance has created...
3.
Ren P, Cui M, Anand O, Xia L, Zhao Z, Sun D, et al.
AAPS J
. 2017 Sep;
19(6):1593-1599.
PMID: 28879628
Administration of proton pump inhibitors (PPIs) through nasogastric tubes may present risks. If the PPI drug products are not prepared properly, clogging or obstruction of nasogastric tubes can pose a...
4.
Wang R, Conner D, Li B
AAPS J
. 2016 Dec;
19(2):360-366.
PMID: 28004346
Oral modified-release (MR) products are dosage forms administered through the mouth and designed to release drug in a controlled manner to achieve maximum efficacy, minimal side effects, and better patient...
5.
Lu D, Lee S, Lionberger R, Choi S, Adams W, Caramenico H, et al.
AAPS J
. 2015 Mar;
17(3):546-57.
PMID: 25758352
International regulatory agencies have developed recommendations and guidances for bioequivalence approaches of orally inhaled drug products (OIDPs) for local action. The objective of this article is to discuss the similarities...
6.
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...
7.
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...
8.
Tampal N, Mandula H, Zhang H, Li B, Nguyen H, Conner D
AAPS PharmSciTech
. 2014 Sep;
16(1):5-9.
PMID: 25245330
Establishing bioequivalence (BE) of drugs indicated to treat cancer poses special challenges. For ethical reasons, often, the studies need to be conducted in cancer patients rather than in healthy volunteers,...
9.
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...
10.
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...