The IND application is the primary pathway through which new drugs and biologics are approved to be tested in human clinical trials. IND-enabling studies are conducted to evaluate potential toxicity risks prior to human studies and to estimate starting doses for clinical trials. Pharmacology, pharmacokinetics, and toxicity evaluations are important IND-enabling studies required for an IND submission. A comprehensive IND-enabling program depends on the class of drug, route of administration, planned indication, and planned duration of treatment. The development of IND-enabling technologies is crucial for accelerating the discovery of new drugs and significantly reducing time to market and safety profile issues.

This brochure contains the following contents:

1. Immuno-Oncology Animal Models
2. Syngeneic Models
3. Cell Line Derived Xenografted (CDX) Models
4. Patient Derived Xenografted (PDX) Models
5. Preclinical Toxicology
6. Mechanism of Action (MoA)
7. Formulation Development