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BioAssay: AID 588219

FDA HLAED, gamma-glutamyl transferase (GGT) increase

The FDA's Spontaneous Reporting System (SRS) database contains over 1.5 million adverse drug reaction (ADR) reports for 8620 drugs/biologics that are listed for 1191 Coding Symbols for Thesaurus of Adverse Reaction (COSTAR) terms of adverse effects. We have linked the trade names of the drugs to 1861 generic names and retrieved molecular structures for each chemical to obtain a set of 1515 more ..
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 Tested Compounds
 Tested Compounds
All(487)
 
 
Active(32)
 
 
Unspecified(455)
 
 
 Tested Substances
 Tested Substances
All(501)
 
 
Active(32)
 
 
Unspecified(469)
 
 
 Related BioAssays
 Related BioAssays
AID: 588219
Data Source: ChEMBL (736792)
Depositor Category: Literature, Extracted
BioAssay Version:
Deposit Date: 2011-09-18
Modify Date: 2014-12-06

Data Table ( Complete ):           View Active Data    View All Data
BioActive Compounds: 32
Description:
Title: Assessment of the health effects of chemicals in humans: II. Construction of an adverse effects database for QSAR modeling.

Abstract: The FDA's Spontaneous Reporting System (SRS) database contains over 1.5 million adverse drug reaction (ADR) reports for 8620 drugs/biologics that are listed for 1191 Coding Symbols for Thesaurus of Adverse Reaction (COSTAR) terms of adverse effects. We have linked the trade names of the drugs to 1861 generic names and retrieved molecular structures for each chemical to obtain a set of 1515 organic chemicals that are suitable for modeling with commercially available QSAR software packages. ADR report data for 631 of these compounds were extracted and pooled for the first five years that each drug was marketed. Patient exposure was estimated during this period using pharmaceutical shipping units obtained from IMS Health. Significant drug effects were identified using a Reporting Index (RI), where RI = (# ADR reports / # shipping units) x 1,000,000. MCASE/MC4PC software was used to identify the optimal conditions for defining a significant adverse effect finding. Results suggest that a significant effect in our database is characterized by > or = 4 ADR reports and > or = 20,000 shipping units during five years of marketing, and an RI > or = 4.0. Furthermore, for a test chemical to be evaluated as active it must contain a statistically significant molecular structural alert, called a decision alert, in two or more toxicologically related endpoints. We also report the use of a composite module, which pools observations from two or more toxicologically related COSTAR term endpoints to provide signal enhancement for detecting adverse effects.
(PMID: 16472241)
Comment
Putative Target:
ChEMBL Target ID: 103956
Target Type: PHENOTYPE
Pref Name: Hepatotoxicity
Confidence: Target assigned is non-molecular
Relationship Type: Non-molecular target assigned
Categorized Comment - additional comments and annotations
From ChEMBL:
Assay Type: ADME
Assay Data Source: Scientific Literature
Result Definitions
Show more
TIDNameDescriptionHistogramTypeUnit
OutcomeThe BioAssay activity outcomeOutcome
1GGT Increase - Activity Score activity commentGGT Increase - Activity Score activity commentString
2GGT Increase - Activity Score standard flagGGT Increase - Activity Score standard flagInteger
3GGT Increase - Activity Score qualifierGGT Increase - Activity Score qualifierString
4GGT Increase - Activity Score published valueGGT Increase - Activity Score published valueFloat
5GGT Increase - Activity Score standard valueGGT Increase - Activity Score standard valueFloat
6GGT Increase - Index Value activity commentGGT Increase - Index Value activity commentString
7GGT Increase - Index Value standard flagGGT Increase - Index Value standard flagInteger
8GGT Increase - Index Value qualifierGGT Increase - Index Value qualifierString
9GGT Increase - Index Value published valueGGT Increase - Index Value published valueFloat
10GGT Increase - Index Value standard valueGGT Increase - Index Value standard valueFloat
11GGT Increase - Number of Reports activity commentGGT Increase - Number of Reports activity commentString
12GGT Increase - Number of Reports standard flagGGT Increase - Number of Reports standard flagInteger
13GGT Increase - Number of Reports qualifierGGT Increase - Number of Reports qualifierString
14GGT Increase - Number of Reports published valueGGT Increase - Number of Reports published valueFloat
15GGT Increase - Number of Reports standard valueGGT Increase - Number of Reports standard valueFloat

Data Table (Concise)
Data Table ( Complete ):     View Active Data    View All Data
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