Application of Augmented Intelligence for Pharmacovigilance Case Seriousness Determination

Author:

Routray Ramani,Tetarenko Niki,Abu-Assal Claire,Mockute Ruta,Assuncao Bruno,Chen Hanqing,Bao Shenghua,Danysz Karolina,Desai Sameen,Cicirello Salvatore,Willis Van,Alford Sharon Hensley,Krishnamurthy Vivek,Mingle Edward

Funder

Celgene

Publisher

Springer Science and Business Media LLC

Subject

Pharmacology (medical),Pharmacology,Toxicology

Reference48 articles.

1. World Health Organization. The importance of pharmacovigilance: safety monitoring of medicinal products. Geneva: World Health Organization; 2002.

2. European Medicines Agency. Guideline on good pharmacovigilance practices. Annex I: definitions (Rev 4). Amsterdam: European Medicines Agency; 2017.

3. US Food and Drug Administration. Investigational new drug safety reporting. 21CFR31232. Silver Spring: U.S. Food and Drug Administration; 2017.

4. US Food and Drug Administration. Individual case safety reports. 2–18. https://www.fdagov/forindustry/datastandards/individualcasesafetyreports/defaulthtm . Accessed Dec 2018.

5. Price J. Pharmacovigilance in crisis: drug safety at a crossroads. Clin Ther. 2018;40(5):790–7. https://doi.org/10.1016/j.clinthera.2018.02.013 .

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