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ADR Data

ADR data are presented in line listings and/or summary tabulations. [Pg.856]

BioPrint consists of a large database and a set of tools with which both the data and the models generated from the data can be accessed. The database contains structural information, in vivo and in vitro data on most of the marketed pharmaceuticals and a variety of other reference compounds. The in vitro data generated consist of panels of pharmacology and early ADME assays. The in vivo data consist of ADR data extracted from drug labels, mechanisms of action, associated therapeutic areas, pharmacokinetic (PK) data and route of administration data. [Pg.28]

The ADR tools in BioPrint assist the user in accessing and implementing the ADR data included in BioPrint. One can quickly access the ADRs listed for a selected compound, the ADRs related to a selected body system, and the ADRs statistically associated with in vitro assay data (ADR associations). The ADR associations can be searched both by assay and by ADR. When searching by assay, ADRs associated with the selected assays and IC50 values are returned along with the risk assessment. The risk information includes the number of compounds that list the ADR, and the number of compounds... [Pg.196]

Adverse drug reaction (ADR) data can be found in a number of sources. Useful resources to start your search include the BNF, SPC, Martindale and AHFS Drug Information [1,3,4]. [Pg.154]

During clinical trials, investigators are instructed to collect all ADRs reported by patients enrolled in the study, which are tabulated. During final study reports or product marketing applications, ADR data are analyzed by treatment arm. Overall analyses of results are restricted to statements regarding the specific patient populations studied. [Pg.384]

The World Health Organisations monitoring centre in Sweden (http //www.who-umc.org) is the place to go for worldwide spontaneous ADR data. The site has a global focus and much useful information besides. [Pg.95]

The websites of major regulatory agencies are also worth visiting regularly for information about specific issues/alerts, bulletins and ADR data. In particular ... [Pg.95]

Disproportionality A statistical indication of a signal in spontaneous ADR data meaning that more reports of a specific drug/ ADR combination have been received than would have been expected as background noise (see p. 46). [Pg.99]

The limitation of the gradient of the potential is particularly important for calculations with ADRs and for data sets that potentially contain noise peaks, since it facilitates the appearance of violations due to incorrect restraints. A standard hannonic potential would put a high penalty on large violations and would introduce larger distortions into the structure. [Pg.255]

Incomplete Information. Incomplete information is not unique to ADR evaluation but is common to all areas of medical practice. The lack of sufficiently detailed, time-related data on drug administration and disease markers may make it impossible to render a reasoned judgment on many ADR cases, leaving them in their original and unsatisfactory anecdotal status. [Pg.826]

The reference safety information is the company core data sheet to determine whether an ADR is listed or unlisted. [Pg.856]

See other pages where ADR Data is mentioned: [Pg.846]    [Pg.847]    [Pg.851]    [Pg.31]    [Pg.421]    [Pg.240]    [Pg.700]    [Pg.701]    [Pg.743]    [Pg.582]    [Pg.74]    [Pg.74]    [Pg.546]    [Pg.14]    [Pg.846]    [Pg.847]    [Pg.851]    [Pg.31]    [Pg.421]    [Pg.240]    [Pg.700]    [Pg.701]    [Pg.743]    [Pg.582]    [Pg.74]    [Pg.74]    [Pg.546]    [Pg.14]    [Pg.688]    [Pg.255]    [Pg.265]    [Pg.73]    [Pg.81]    [Pg.87]    [Pg.90]    [Pg.69]    [Pg.100]    [Pg.166]    [Pg.170]    [Pg.183]    [Pg.824]    [Pg.825]    [Pg.826]    [Pg.845]    [Pg.845]    [Pg.846]    [Pg.847]    [Pg.848]    [Pg.849]    [Pg.851]    [Pg.851]    [Pg.853]    [Pg.855]   


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