(Q46362415)

21 December 2017

title

The U.S. Food and Drug Administration's Mini-Sentinel program: status and direction (English)

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21 December 2017

author

Ryan M Carnahan

2

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21 December 2017

Jeffrey Brown

3

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21 December 2017

Elizabeth A Chrischilles

Elizabeth Chrischilles

4

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Richard Platt

1

Richard Platt

1 reference

21 December 2017

Sebastian Schneeweiss

10

Sebastian Schneeweiss

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21 December 2017

Melissa A Robb

9

Melissa Robb

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21 December 2017

Judith A Racoosin

8

Judith A Racoosin

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21 December 2017

author name string

Lesley H Curtis

5

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21 December 2017

Sean Hennessy

6

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21 December 2017

Jennifer C Nelson

7

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21 December 2017

Sengwee Toh

11

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21 December 2017

Mark G Weiner

12

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21 December 2017

publication date

1 January 2012

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21 December 2017

Pharmacoepidemiology and Drug Safety

published in

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21 December 2017

volume

21 Suppl 1

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21 December 2017

page(s)

1-8

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21 December 2017

Developing the Sentinel System--a national resource for evidence development

cites work

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The organizational structure and governing principles of the Food and Drug Administration's Mini-Sentinel pilot program

21 January 2018

1 reference

A policy framework for public health uses of electronic health data

21 January 2018

1 reference

Design considerations, architecture, and use of the Mini-Sentinel distributed data system

21 January 2018

1 reference

The Food and Drug Administration's Post-Licensure Rapid Immunization Safety Monitoring program: strengthening the federal vaccine safety enterprise

21 January 2018

1 reference

Design considerations in an active medical product safety monitoring system.

21 January 2018

1 reference

Using high-dimensional propensity scores to automate confounding control in a distributed medical product safety surveillance system.

21 January 2018

1 reference

When should case-only designs be used for safety monitoring of medical products?

21 January 2018

1 reference

Effects of adjusting for instrumental variables on bias and precision of effect estimates

21 January 2018

1 reference

Challenges in the design and analysis of sequentially monitored postmarket safety surveillance evaluations using electronic observational health care data

21 January 2018

1 reference

Statistical approaches to group sequential monitoring of postmarket safety surveillance data: current state of the art for use in the Mini-Sentinel pilot

21 January 2018

1 reference

Mini-Sentinel's systematic reviews of validated methods for identifying health outcomes using administrative and claims data: methods and lessons learned

21 January 2018

1 reference

Mini-Sentinel's systematic reviews of validated methods for identifying health outcomes using administrative data: summary of findings and suggestions for future research

21 January 2018

1 reference

Design for validation of acute myocardial infarction cases in Mini-Sentinel

21 January 2018

1 reference

A protocol for active surveillance of acute myocardial infarction in association with the use of a new antidiabetic pharmaceutical agent

21 January 2018

1 reference

A systematic review of validated methods for identifying cerebrovascular accident or transient ischemic attack using administrative data

21 January 2018

1 reference

A systematic review of validated methods for identifying atrial fibrillation using administrative data

21 January 2018

1 reference

A systematic review of validated methods for identifying anaphylaxis, including anaphylactic shock and angioneurotic edema, using administrative and claims data

21 January 2018

1 reference

A systematic review of validated methods for identifying heart failure using administrative data

21 January 2018

1 reference

A systematic review of validated methods for identifying ventricular arrhythmias using administrative and claims data

21 January 2018

1 reference

A systematic review of validated methods for identifying hypersensitivity reactions other than anaphylaxis (fever, rash, and lymphadenopathy), using administrative and claims data

21 January 2018

1 reference

A systematic review of validated methods for identifying venous thromboembolism using administrative and claims data

21 January 2018

1 reference

A systematic review of validated methods for identifying seizures, convulsions, or epilepsy using administrative and claims data

21 January 2018

1 reference

A systematic review of validated methods for identifying erythema multiforme major/minor/not otherwise specified, Stevens-Johnson Syndrome, or toxic epidermal necrolysis using administrative and claims data

21 January 2018

1 reference

A systematic review of validated methods for identifying depression using administrative data

21 January 2018

1 reference

A systematic review of validated methods for identifying acute respiratory failure using administrative and claims data

21 January 2018

1 reference

A systematic review of validated methods for identifying orthopedic implant removal and revision using administrative data

21 January 2018

1 reference

A systematic review of validated methods for identifying pancreatitis using administrative data

21 January 2018

1 reference

A systematic review of validated methods for identifying pulmonary fibrosis and interstitial lung disease using administrative and claims data

21 January 2018

1 reference

A systematic review of validated methods for identifying infection related to blood products, tissue grafts, or organ transplants using administrative data

21 January 2018

1 reference

A systematic review of validated methods for identifying transfusion-related sepsis using administrative and claims data

21 January 2018

1 reference

A systematic review of validated methods for identifying transfusion-related ABO incompatibility reactions using administrative and claims data

21 January 2018

1 reference

A systematic review of validated methods for identifying suicide or suicidal ideation using administrative or claims data

21 January 2018

1 reference

A systematic review of validated methods for identifying lymphoma using administrative data

21 January 2018

1 reference

21 January 2018

Identifiers

DOI

10.1002/PDS.2343

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21 December 2017

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21 December 2017