Target Adverse Event Profiles for Predictive Safety in the Postmarket Setting-Reference-Cited by-同舟云学术

Target Adverse Event Profiles for Predictive Safety in the Postmarket Setting

Published:2020-11-07 Issue:5 Volume:109 Page:1232-1243
ISSN:0009-9236
Container-title:Clinical Pharmacology & Therapeutics
language:en
Short-container-title:Clin. Pharmacol. Ther.

Author:

Schotland Peter¹,Racz Rebecca¹,Jackson David B.²,Soldatos Theodoros G.²,Levin Robert³,Strauss David G.¹,Burkhart Keith¹

Affiliation:

1. Division of Applied Regulatory Science Office of Clinical Pharmacology Center for Drug Evaluation and Research US Food and Drug Administration Silver Spring Maryland USA

2. Molecular Health GmbH Heidelberg Germany

3. Office of Surveillance and Epidemiology Center for Drug Evaluation and Research US Food and Drug Administration Silver Spring Maryland USA

Publisher

Wiley

Subject

Pharmacology (medical),Pharmacology

Link

https://onlinelibrary.wiley.com/doi/pdf/10.1002/cpt.2074

Reference72 articles.

1. Postmarket Safety Events Among Novel Therapeutics Approved by the US Food and Drug Administration Between 2001 and 2010

2. Building a knowledge base of severe adverse drug events based on AERS reporting data using semantic web technologies;Jiang G.;Stud. Health Technol. Inform.,2013

3. Automatic signal extraction, prioritizing and filtering approaches in detecting post-marketing cardiovascular events associated with targeted cancer drugs from the FDA Adverse Event Reporting System (FAERS)

4. Target-Adverse Event Profiles to Augment Pharmacovigilance: A Pilot Study With Six New Molecular Entities

5. In Silico Profiling of Clinical Phenotypes for Human Targets Using Adverse Event Data

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