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BioAssay: AID 588215

FDA HLAED, alkaline phosphatase 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(61)
 
 
Unspecified(426)
 
 
 Tested Substances
 Tested Substances
All(501)
 
 
Active(62)
 
 
Unspecified(439)
 
 
 Related BioAssays
 Related BioAssays
AID: 588215
Data Source: ChEMBL (736788)
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: 61
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
1Alkaline Phosphatase Increase - Activity Score activity commentAlkaline Phosphatase Increase - Activity Score activity commentString
2Alkaline Phosphatase Increase - Activity Score standard flagAlkaline Phosphatase Increase - Activity Score standard flagInteger
3Alkaline Phosphatase Increase - Activity Score qualifierAlkaline Phosphatase Increase - Activity Score qualifierString
4Alkaline Phosphatase Increase - Activity Score published valueAlkaline Phosphatase Increase - Activity Score published valueFloat
5Alkaline Phosphatase Increase - Activity Score standard valueAlkaline Phosphatase Increase - Activity Score standard valueFloat
6Alkaline Phosphatase Increase - Index Value activity commentAlkaline Phosphatase Increase - Index Value activity commentString
7Alkaline Phosphatase Increase - Index Value standard flagAlkaline Phosphatase Increase - Index Value standard flagInteger
8Alkaline Phosphatase Increase - Index Value qualifierAlkaline Phosphatase Increase - Index Value qualifierString
9Alkaline Phosphatase Increase - Index Value published valueAlkaline Phosphatase Increase - Index Value published valueFloat
10Alkaline Phosphatase Increase - Index Value standard valueAlkaline Phosphatase Increase - Index Value standard valueFloat
11Alkaline Phosphatase Increase - Number of Reports activity commentAlkaline Phosphatase Increase - Number of Reports activity commentString
12Alkaline Phosphatase Increase - Number of Reports standard flagAlkaline Phosphatase Increase - Number of Reports standard flagInteger
13Alkaline Phosphatase Increase - Number of Reports qualifierAlkaline Phosphatase Increase - Number of Reports qualifierString
14Alkaline Phosphatase Increase - Number of Reports published valueAlkaline Phosphatase Increase - Number of Reports published valueFloat
15Alkaline Phosphatase Increase - Number of Reports standard valueAlkaline Phosphatase Increase - Number of Reports standard valueFloat

Data Table (Concise)
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