PMID- 33090463
OWN - NLM
STAT- MEDLINE
DCOM- 20210915
LR  - 20231107
IS  - 1532-6535 (Electronic)
IS  - 0009-9236 (Print)
IS  - 0009-9236 (Linking)
VI  - 109
IP  - 5
DP  - 2021 May
TI  - Target Adverse Event Profiles for Predictive Safety in the Postmarket Setting.
PG  - 1232-1243
LID - 10.1002/cpt.2074 [doi]
AB  - We improved a previous pharmacological target adverse-event (TAE) profile model 
      to predict adverse events (AEs) on US Food and Drug Administration (FDA) drug 
      labels at the time of approval. The new model uses more drugs and features for 
      learning as well as a new algorithm. Comparator drugs sharing similar target 
      activities to a drug of interest were evaluated by aggregating AEs from the FDA 
      Adverse Event Reporting System (FAERS), FDA drug labels, and medical literature. 
      An ensemble machine learning model was used to evaluate FAERS case count, 
      disproportionality scores, percent of comparator drug labels with a specific AE, 
      and percent of comparator drugs with the reports of the event in the literature. 
      Overall classifier performance was F1 of 0.71, area under the precision-recall 
      curve of 0.78, and area under the receiver operating characteristic curve of 
      0.87. TAE analysis continues to show promise as a method to predict adverse 
      events at the time of approval.
CI  - (c) 2020 Molecular Health GMBH. Clinical Pharmacology & Therapeutics published by 
      Wiley Periodicals LLC on behalf of American Society for Clinical Pharmacology and 
      Therapeutics.
FAU - Schotland, Peter
AU  - Schotland P
AD  - Division of Applied Regulatory Science, Office of Clinical Pharmacology, Center 
      for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, 
      Maryland, USA.
FAU - Racz, Rebecca
AU  - Racz R
AD  - Division of Applied Regulatory Science, Office of Clinical Pharmacology, Center 
      for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, 
      Maryland, USA.
FAU - Jackson, David B
AU  - Jackson DB
AD  - Molecular Health GmbH, Heidelberg, Germany.
FAU - Soldatos, Theodoros G
AU  - Soldatos TG
AD  - Molecular Health GmbH, Heidelberg, Germany.
FAU - Levin, Robert
AU  - Levin R
AD  - Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research, 
      US Food and Drug Administration, Silver Spring, Maryland, USA.
FAU - Strauss, David G
AU  - Strauss DG
AD  - Division of Applied Regulatory Science, Office of Clinical Pharmacology, Center 
      for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, 
      Maryland, USA.
FAU - Burkhart, Keith
AU  - Burkhart K
AD  - Division of Applied Regulatory Science, Office of Clinical Pharmacology, Center 
      for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, 
      Maryland, USA.
LA  - eng
PT  - Journal Article
PT  - Research Support, U.S. Gov't, P.H.S.
DEP - 20201107
PL  - United States
TA  - Clin Pharmacol Ther
JT  - Clinical pharmacology and therapeutics
JID - 0372741
SB  - IM
EIN - Clin Pharmacol Ther. 2023 Dec;114(6):1387. PMID: 37899631
MH  - *Adverse Drug Reaction Reporting Systems
MH  - *Algorithms
MH  - Data Mining
MH  - Drug Labeling
MH  - Drug-Related Side Effects and Adverse Reactions
MH  - Humans
MH  - Machine Learning
MH  - *Pharmacovigilance
MH  - United States
MH  - United States Food and Drug Administration
PMC - PMC8246740
COIS- D.B.J. is an employee of Molecular Health, GmbH, a shareholder in Molecular 
      Health, GmbH, and inventor of the EFFECT technology; T.G.S. is an employee of 
      Molecular Health, GmbH and a shareholder in Molecular Health, GmbH and inventor 
      of the EFFECT technology. All other authors declare no competing interests for 
      this work.
EDAT- 2020/10/23 06:00
MHDA- 2021/09/16 06:00
PMCR- 2020/11/07
CRDT- 2020/10/22 12:19
PHST- 2019/09/20 00:00 [received]
PHST- 2020/08/31 00:00 [accepted]
PHST- 2020/10/23 06:00 [pubmed]
PHST- 2021/09/16 06:00 [medline]
PHST- 2020/10/22 12:19 [entrez]
PHST- 2020/11/07 00:00 [pmc-release]
AID - CPT2074 [pii]
AID - 10.1002/cpt.2074 [doi]
PST - ppublish
SO  - Clin Pharmacol Ther. 2021 May;109(5):1232-1243. doi: 10.1002/cpt.2074. Epub 2020 
      Nov 7.