A Review of Statistical Methods for Safety Surveillance

Lan Huang, Ted Guo, Jyoti Zalkikar, Ram C. Tiwari

Type: Review

Publication Date: 2013-12-10

Citations: 64

DOI: https://doi.org/10.1177/2168479013514236

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Locations

Therapeutic Innovation & Regulatory Science - View
PubMed - View

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Works That Cite This (25)

Action	Title	Year	Authors
+ PDF Chat	Mixture drug‐count response model for the high‐dimensional drug combinatory effect on myopathy	2017	Xueying Wang Pengyue Zhang Chien‐Wei Chiang Heng‐Yi Wu Li Shen Xia Ning Donglin Zeng Lei Wang Sara K. Quinney Weixing Feng
+	Detection algorithms and attentive points of safety signal using spontaneous reporting systems as a clinical data source	2021	Yoshihiro Noguchi Tomoya Tachi Hitomi Teramachi
+	Signal detection in FDA AERS database using Dirichlet process	2015	Na Hu Lan Huang Ram C. Tiwari
+	Statistical Methods for Clinical Study Site Selection	2019	Jianjin Xu Lan Huang Zhihao Yao Zhiheng Xu Jyoti Zalkikar Ram C. Tiwari
+	A nonparametric method to detect increased frequencies of adverse drug reactions over time	2018	Günter Heimann Rossella Belleli Jouni Kerman Roland Fisch Joseph M. Kahn Sigrid Behr Conny Berlin
+	Extended likelihood ratio test-based methods for signal detection in a drug class with application to FDA’s adverse event reporting system database	2016	Yueqin Zhao Min Yi Ram C. Tiwari
+ PDF Chat	Some features of statistical analysis of spontaneous adverse drug reporting data	2024	И. Б. Бондарева S. К. Zyryanov I. L. Asetskaya E. N. Terekhina
+	Logistic Regression Likelihood Ratio Test Analysis for Detecting Signals of Adverse Events in Post-market Safety Surveillance	2017	Kijoeng Nam Nicholas C. Henderson Patricia Rohan Emily Jane Woo Estelle Russek‐Cohen
+ PDF Chat	A tree-based scan statistic for zero-inflated count data in post-market drug safety surveillance	2022	Goeun Park Inkyung Jung
+ PDF Chat	Comparison of Data Mining Methods for the Signal Detection of Adverse Drug Events with a Hierarchical Structure in Postmarketing Surveillance	2020	Goeun Park Heesun Jung Seok‐Jae Heo Inkyung Jung

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+ PDF Chat	Statistical approaches to group sequential monitoring of postmarket safety surveillance data: current state of the art for use in the Mini‐Sentinel pilot	2012	Andrea J. Cook Ram C. Tiwari Robert Wellman Susan R. Heckbert Lingling Li Patrick J. Heagerty Tracey Marsh Jennifer C. Nelson
+	Extending the methods used to screen the WHO drug safety database towards analysis of complex associations and improved accuracy for rare events	2005	G. Niklas Norén Andrew Bate Roland Orre I. Ralph Edwards
+	Use of Screening Algorithms and Computer Systems to Efficiently Signal Higher-Than-Expected Combinations of Drugs and Events in the US FDA??s Spontaneous Reports Database	2002	Ana Szarfman Stella G. Machado Robert T. O Neill
+	Use of proportional reporting ratios (PRRs) for signal generation from spontaneous adverse drug reaction reports	2001	Stephen Evans Patrick Waller Sarah Davis
+	A Likelihood Ratio Test Based Method for Signal Detection With Application to FDA’s Drug Safety Data	2011	Lan Huang Jyoti Zalkikar Ram C. Tiwari
+ PDF Chat	Effects of Stratification on Data Mining in the US Vaccine Adverse Event Reporting System (VAERS)	2008	Emily Jane Woo Robert Ball Dale R. Burwen M. Miles Braun
+	Applying Bayesian Model Averaging to mechanistic models: An example and comparison of methods	2008	James Gibbons G.M. Cox Andrew T. A. Wood J. Craigon Stephen J. Ramsden Davide Tarsitano N.M.J. Crout
+ PDF Chat	A Maximized Sequential Probability Ratio Test for Drug and Vaccine Safety Surveillance	2011	Martin Kulldorff Robert L. Davis MARGARETTE S. KOLCZAK Edwin Lewis Tracy A. Lieu Richard Platt
+	Likelihood Ratio Test-Based Method for Signal Detection in Drug Classes Using FDA's AERS Database	2013	Lan Huang Jyoti Zalkikar Ram C. Tiwari
+ PDF Chat	Comparing data mining methods on the VAERS database	2005	David Banks Emily Jane Woo Dale R. Burwen Phil Perucci M. Miles Braun Robert Ball