Animal Toxicological Data

Animal toxicological data originates from contract research organizations (CROs) or pharmaceutical testing laboratories that conduct safety studies and send this transaction set to regulatory agencies, pharmaceutical sponsors, or data management firms receiving and archiving study results. Typically transmitted in response to a regulatory requirement or as part of a formal study data submission, the transaction set structures animal study parameters, dosing information, and individual animal observations through key segments including the STP (Study Parameters) segment that defines the overall test protocol, the GRP (Group Dosage Parameters) segment that establishes treatment cohorts, and the ANI (Animal Identification) segment that tracks individual subjects and their toxicological responses.

For example, Exotech Laboratories completes a 90-day oral toxicity study on laboratory rats for Pharmacore Inc. and transmits an AT249 transaction to Pharmacore’s data management department. The transmission includes study parameters established in the STP segment, identifies the test article and dosing levels through GRP, and documents each animal’s identification, assigned dose group, clinical observations recorded at specific locations via AOL segments, and resulting pathology findings through ATR segments. Notes attached via NTE segments provide context for significant findings, enabling Pharmacore’s safety team to efficiently import and validate the complete study dataset for regulatory filing without manual re-entry or formatting errors.