How is animal toxicity observation mapped to human clinical data and adverse effects?
MedDRA, a thesaurus published by the ICH and RTECS ® were used:
- RTECS terms have been mapped to the proper term and level of the MedDRA hierarchy, and then these RTECS terms are added to the Thesaurus as synonyms to these MedDRA terms. When there are RTECS terms that cannot be mapped, specific entries are added to the hierarchy.
- Extracted preclinical (animal) and clinical data and (post-market) AERS records extracted from the sources in PharmaPendium (for example the FDA Approval Packages, Meyler’s) were mapped to this thesaurus.
- This allowed the PharmaPendium interface to provide a longitudinal view from preclinical (animal), to clinical to post-market data.
PharmaPendium is designed to provide its users with a “longitudinal” view of preclinical, clinical, and post market data, which are filtered by user-defined parameters (target, class, chemistry, adverse effects). As a user looks at a particular drug’s data view they can toggle between observed animal effects, clinically-observed effects, and post market reports. This allows a research thread that examines how animal effects correlated to clinical (human) effects, and finally to the general population (post market).
This is the only content offering that makes such a research thread possible, allowing further investigation on the predictability of certain animal studies, species-specific effects, etc.
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