Module 12 Presentations

26/01/2024

SEND Original Consortium Members

Industry Abbott Amgen AstraZeneca BMS Boehringer-Ingelheim Eli Lilly & Co. GSK Merck Novartis

CROs Covance

Vendors PharmQuest

Charles River MPI Research

HHS CBER / FDA CDER / FDA CFSAN / FDA CVM / FDA NCTR / FDA NIEHS / NIH

P&GP Pfizer Sanofi Aventis Schering

The Organisation for Professionals in Regulatory Affairs

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Standard for Exchange of Nonclinical Data(SEND)

Dataset

Description

BW

Body Weights

CO

Comments

SEND defines domains and variables for submitting all data generated from animal toxicity studies ● Includes: single- and repeat dose toxicity, carcinogenicity, safety pharmacology, reproductive toxicity, and rodent micronucleus studies

CP

Clinical Pathology

Clinical Signs, PE, and Ophthalmoscopic Examination

CS

DL

Drug/Metabolite Levels

DS EG

Disposition

ECG Test Results

EX

Exposure

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