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Open access

Research article

First published 2014-7

Investigators’ Experience With Expedited Safety Reports Prior to the FDA’s Final IND Safety Reporting Rule

Judith M. Kramer, David Vock, Howard E. Greenberg [...]

Therapeutic Innovation & Regulatory Science

Open access

Research article

First published 2014-3

Optimizing Expedited Safety Reporting for Drugs and Biologics Subject to an Investigational New Drug Application

Patrick Archdeacon, Cheryl Grandinetti, José M. Vega [...]

Therapeutic Innovation & Regulatory Science

Retricted access

Research article

First published 1992-1

Worldwide Regulations for Manufacturers on Clinical Safety Surveillance of Drugs

Arnold J. Gordon, Robert J. Petrick

Therapeutic Innovation & Regulatory Science

Retricted access

Other

First published 1992-10

An Industry Perspective on the State of Confusion in International ADR Reporting: Current Requirements and Attempts at Standardization

Arnold J. Gordon

Therapeutic Innovation & Regulatory Science

Free access

Brief report

First published 2018-03

Relations Between Self-Reported and Linguistic Monitoring Assessments of Affective Experience in an Extreme Environment

Nathan Smith

Wilderness & Environmental Medicine

Open access

Research article

First published 2018

Expediting toxicity testing with increased precision,predictive power,and clinical utility

Peter Pressman, A Wallace Hayes, Roger Clemens

Toxicology Research and Application

Retricted access

Research article

First published 2014-11

Industry Practices for Expedited Reporting to Investigators Conducting Research Under an IND

Sundeep S. Sethi, Judith M. Kramer, Suzanne Gagnon [...]

Therapeutic Innovation & Regulatory Science

Retricted access

Research article

First published 2017-5

Applied Use of Safety Event Occurrence Control Charts of Harm and Non-Harm Events: A Case Study

Susan N. Robinson, David M. Neyens, Thomas Diller

American Journal of Medical Quality

Retricted access

Research article

First published 2016-11

A Bayesian Exposure-Time Method for Clinical Trial Safety Monitoring With Blinded Data

Patrick M. Schnell, Greg Ball

Therapeutic Innovation & Regulatory Science

Retricted access

Research article

First published 2025-3

Improving Highway Work Zone Mobility in the Developing World: A Systematic Literature Review of Work Zone Delay Measures and Technological Solutions

Faijan Ali Ansari, Agnivesh Pani, Smruti Sourava Mohapatra

Transportation Research Record: Journal of the Transportation Research Board

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