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Articles (133)

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1-10 of 133 results for postmarketing clinical study

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Select article: A System for Handling Unsolicited Postmarketing Study Proposals

Retricted access

Research article

First published 1993-4

A System for Handling Unsolicited Postmarketing Study Proposals

Mary Jane Baine

Therapeutic Innovation & Regulatory Science

Select article: Clinical Features of Disseminated Intravascular Coagulation According to the French-American-British Classification in Patients With Acute Leukemia and Thrombomodulin Alfa Treatment—A Cohort Study Using a Postmarketing Surveillance Database

Open access

Research article

First published 2021

Clinical Features of Disseminated Intravascular Coagulation According to the French-American-British Classification in Patients With Acute Leukemia and Thrombomodulin Alfa Treatment—A Cohort Study Using a Postmarketing Surveillance Database

Seki Yoshinobu, Goichi Honda, Noriaki Kawano [...]

Clinical and Applied Thrombosis/Hemostasis

Select article: Legal Requirements,Definitions,and Standards for Non-interventional Drug Studies

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Research article

First published 2013-11

Legal Requirements,Definitions,and Standards for Non-interventional Drug Studies

Markus Hartmann, Patricia Schaffner

Therapeutic Innovation & Regulatory Science

Select article: US Food and Drug Administration utilization of postmarketing requirements and postmarketing commitments,2009–2018

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Research article

First published 2021-8

US Food and Drug Administration utilization of postmarketing requirements and postmarketing commitments,2009–2018

Joshua J Skydel, Audrey D Zhang, Sanket S Dhruva [...]

Clinical Trials

Select article: Postmarketing Surveillance Methodologies

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Other

First published 1988-1

Postmarketing Surveillance Methodologies

Stanley A. Edlavitch

Annals of Pharmacotherapy

Select article: Adjustment for Propensity Score in Nonrandomized Clinical Studies

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Research article

First published 2017-1

Adjustment for Propensity Score in Nonrandomized Clinical Studies

Satoru Fukimbara, Kouji Niibe, Michio Yamamoto [...]

Therapeutic Innovation & Regulatory Science

Select article: On the evidence consistency of pharmacovigilance outcomes between Food and Drug Administration Adverse Event Reporting System and electronic medical record data for acute mania patients

Free access

Research article

First published 2020-6

On the evidence consistency of pharmacovigilance outcomes between Food and Drug Administration Adverse Event Reporting System and electronic medical record data for acute mania patients

Rui Duan, Xinyuan Zhang, Jingcheng Du [...]

Health Informatics Journal

Select article: Postmarketing Surveillance Studies: Practical Issues in Design and Management

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Research article

First published 1994-7

Postmarketing Surveillance Studies: Practical Issues in Design and Management

Cynthia Lauber-Huber

Therapeutic Innovation & Regulatory Science

Select article: Water under the Bridge: Postmarketing Concerns as Related to Pediatric Populations

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Research article

First published 1996-10

Water under the Bridge: Postmarketing Concerns as Related to Pediatric Populations

Mario F. Sylvestri

Therapeutic Innovation & Regulatory Science

Select article: The US Food and Drug Administration’s expedited approval programs: Evidentiary standards,regulatory trade-offs,and potential improvements

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Research article

First published 2018-6

The US Food and Drug Administration’s expedited approval programs: Evidentiary standards,regulatory trade-offs,and potential improvements

Joshua D Wallach, Joseph S Ross, Huseyin Naci

Clinical Trials

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