scholarly journals What Can Be Learned from Recent New Drug Applications? A Systematic Review of Drug Interaction Data for Drugs Approved by the US FDA in 2015

2016 ◽  
Vol 45 (1) ◽  
pp. 86-108 ◽  
Author(s):  
Jingjing Yu ◽  
Zhu Zhou ◽  
Katie H. Owens ◽  
Tasha K. Ritchie ◽  
Isabelle Ragueneau-Majlessi
Keyword(s):  
Systematic Review ◽  
Drug Interaction ◽  
Interaction Data ◽  
New Drug ◽  
The Us ◽  
Us Fda

Drug Disposition and Drug-Drug Interaction Data in 2013 FDA New Drug Applications: A Systematic Review

2014 ◽  
Vol 42 (12) ◽  
pp. 1991-2001 ◽  
Author(s):  
Jingjing Yu ◽  
Tasha K. Ritchie ◽  
Aditi Mulgaonkar ◽  
Isabelle Ragueneau-Majlessi
Keyword(s):  
Systematic Review ◽  
Drug Interaction ◽  
Drug Disposition ◽  
Interaction Data ◽  
New Drug ◽  
Drug Drug Interaction

scholarly journals Association of HLA-B*5701 Genotypes and Abacavir-Induced Hypersensitivity Reaction: A Systematic Review and Meta-Analysis

2015 ◽  
Vol 18 (1) ◽  
pp. 68 ◽  
Author(s):  
Wimonchat Tangamornsuksan ◽  
Ornrat Lohitnavy ◽  
Chuenjid Kongkaew ◽  
Nathorn Chaiyakunapruk ◽  
Brad Reisfeld ◽  
...  
Keyword(s):  
Systematic Review ◽  
Hypersensitivity Reaction ◽  
Diagnostic Criteria ◽  
Random Effects ◽  
Meta Analysis ◽  
Random Effects Model ◽  
Analysis Technique ◽  
The Us ◽  
Us Fda ◽  
Immunologic Test

OBJECTIVES: This study aimed to systematically review and quantitatively synthesize the association between HLA-B*5701 and abacavir-induced hypersensitivity reaction (ABC-HSR). METHODS: We searched for studies that investigated the association between HLA-B genotype and ABC-HSR and provided information about the frequency of carriers of HLA-B genotypes among cases and controls. We then performed a meta-analysis with a random-effects model to pool the data and to investigate the sources of heterogeneity. RESULTS: From 1,026 articles identified, ten studies were included. Five using clinical manifestation as their diagnostic criteria, 409 and 1,883 subjects were included as cases and controls. Overall OR was 23.6 (95% CI = 15.4 – 36.3). Whereas, the another five studies using confirmed immunologic test as their diagnostic criteria, 110 and 1,968 subjects were included as cases and controls, respectively. The association of ABC-HSR was strong in this populations with HLA-B*5701. Overall OR was 1,056.2 (95% CI = 345.0 – 3,233.3). CONCLUSIONS: Using meta-analysis technique, the association between HLA-B*5701 and ABC-HSR is strong in the studies using immunologic confirmation to identify ABC-HSR. These results support the US FDA recommendations for screening HLA-B*5701 allele before initiating abacavir therapy.This article is open to POST-PUBLICATION REVIEW. Registered readers (see “For Readers”) may comment by clicking on ABSTRACT on the issue’s contents page.

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