Discovery
Medicinal Chemistry Services
Discovery ADME
- Metabolic Stability
- CYP Interaction
- Permeability & Transporters
- Physicochemical Properties
- Protein Binding
SEND is the Standard for Exchange of Nonclinical Data. It is the standard data format and terminology required for the submission of preclinical single- and repeat-dose general toxicology studies in support of Investigational New Drug (IND) or New Drug Application (NDA) submissions to the Food and Drug Administration’s (FDA) Center for Drug Evaluation and Review (CDER).
According to CDISC, “SEND is one of the required standards for data submission to FDA.” An implementation guide for SEND is meant to support data typically found in single-dose general toxicology, repeat-dose general toxicology, carcinogenicity studies, and safety pharmacology studies. However additional implementation guides have also been created to support DART studies.