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Medical Product Safety Evaluation: Biological Models and Statistical Methods

1, 2018

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Multiple testing with discrete data: Proportion of true null hypotheses and two adaptive FDR procedures

Biometrical journal, 2018-07, Vol.60 (4), p.761-779

2018

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Use of the false discovery rate for evaluating clinical safety data

Statistical methods in medical research, 2004-06, Vol.13 (3), p.227-238

2004

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Improved power of familywise error rate procedures for discrete data under dependency

Biometrical journal, 2019-01, Vol.61 (1), p.101-114

2019

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The use of strictly standardized mean difference for hit selection in primary RNA interference high-throughput screening experiments

Journal of biomolecular screening, 2007-06, Vol.12 (4), p.497-509

2007

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Safety and Efficacy of a Pentavalent Human–Bovine (WC3) Reassortant Rotavirus Vaccine

The New England journal of medicine, 2006-01, Vol.354 (1), p.23-33

2006

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Controlling false discovery proportion in identification of drug‐related adverse events from multiple system organ classes

Statistics in medicine, 2019-09, Vol.38 (22), p.4378-4389

2019

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Efficient methods for signal detection from correlated adverse events in clinical trials

Biometrics, 2019-09, Vol.75 (3), p.1000-1008

2019

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Efficient Multiple Imputation for Sensitivity Analysis of Recurrent Events Data with Informative Censoring

Statistics in biopharmaceutical research, 2022-04, Vol.14 (2), p.153-161

2022

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Bayesian probability of success for clinical trials using historical data

Statistics in medicine, 2015-01, Vol.34 (2), p.249-264

2015

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On inference of control-based imputation for analysis of repeated binary outcomes with missing data

Journal of biopharmaceutical statistics, 2017-05, Vol.27 (3), p.358-372

2017

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Determination of sample size in genome-scale RNAi screens

Bioinformatics, 2009-04, Vol.25 (7), p.841-844

2009

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Sequential generalized likelihood ratio tests for vaccine safety evaluation

Statistics in medicine, 2010-11, Vol.29 (26), p.2698-2708

2010

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Periodic benefit-risk assessment using Bayesian stochastic multi-criteria acceptability analysis

Contemporary clinical trials, 2018-04, Vol.67, p.100-108

2018

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Control‐based imputation for sensitivity analyses in informative censoring for recurrent event data

Pharmaceutical statistics : the journal of the pharmaceutical industry, 2017-11, Vol.16 (6), p.424-432

2017

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Cholesterol reduction yields clinical benefit: Impact of statin trials

Circulation (New York, N.Y.), 1998-03, Vol.97 (10), p.946-952

1998

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Impact of Indinavir on the Quality of Life in Patients with Advanced HIV Infection Treated with Zidovudine and Lamivudine

Clinical infectious diseases, 2004-08, Vol.39 (3), p.426-433

2004

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Use of an angular transformation for ratio estimation in cost-effectiveness analysis

Statistics in medicine, 2000-11, Vol.19 (21), p.2989-3003

2000

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Age Dependence of the Risk of Intussusception Following Tetravalent Rhesus-Human Reassortant Rotavirus Tetravalent Vaccine: Is It Beyond Doubt?

American journal of epidemiology, 2010-05, Vol.171 (9), p.1046-1054, Article 1046

2010

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cSSMD: assessing collective activity for addressing off-target effects in genome-scale RNA interference screens

Bioinformatics, 2011-10, Vol.27 (20), p.2775-2781

2011

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Assessing the appropriateness of combining economic data from multinational clinical trials

Statistics in medicine, 2003-06, Vol.22 (12), p.1955-1976

2003

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Hit selection with false discovery rate control in genome-scale RNAi screens

Nucleic acids research, 2008-08, Vol.36 (14), p.4667

2008

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Medical Records-Based Postmarketing Safety Evaluation of Rare Events with Uncertain Status

Journal of biopharmaceutical statistics, 2013-07, Vol.23 (4), p.744-755

2013

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Inverse relationship between six week postvaccination varicella antibody response to vaccine and likelihood of long term breakthrough infection

The Pediatric infectious disease journal, 2002-04, Vol.21 (4), p.337-342

2002

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Medical Product Safety Evaluation: Biological Models and Statistical Methods

Multiple testing with discrete data: Proportion of true null hypotheses and two adaptive FDR procedures

Use of the false discovery rate for evaluating clinical safety data

Improved power of familywise error rate procedures for discrete data under dependency

The use of strictly standardized mean difference for hit selection in primary RNA interference high-throughput screening experiments

Safety and Efficacy of a Pentavalent Human–Bovine (WC3) Reassortant Rotavirus Vaccine

Controlling false discovery proportion in identification of drug‐related adverse events from multiple system organ classes

Efficient methods for signal detection from correlated adverse events in clinical trials

Efficient Multiple Imputation for Sensitivity Analysis of Recurrent Events Data with Informative Censoring

Analyzing multiple endpoints in clinical trials of pain treatments: IMMPACT recommendations

Bayesian probability of success for clinical trials using historical data

On inference of control-based imputation for analysis of repeated binary outcomes with missing data

Determination of sample size in genome-scale RNAi screens

Sequential generalized likelihood ratio tests for vaccine safety evaluation

Periodic benefit-risk assessment using Bayesian stochastic multi-criteria acceptability analysis

Control‐based imputation for sensitivity analyses in informative censoring for recurrent event data

Cholesterol reduction yields clinical benefit: Impact of statin trials

Impact of Indinavir on the Quality of Life in Patients with Advanced HIV Infection Treated with Zidovudine and Lamivudine

Use of an angular transformation for ratio estimation in cost-effectiveness analysis

Age Dependence of the Risk of Intussusception Following Tetravalent Rhesus-Human Reassortant Rotavirus Tetravalent Vaccine: Is It Beyond Doubt?

cSSMD: assessing collective activity for addressing off-target effects in genome-scale RNA interference screens

Assessing the appropriateness of combining economic data from multinational clinical trials

Hit selection with false discovery rate control in genome-scale RNAi screens

Medical Records-Based Postmarketing Safety Evaluation of Rare Events with Uncertain Status

Inverse relationship between six week postvaccination varicella antibody response to vaccine and likelihood of long term breakthrough infection

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