Pharmacology and Toxicology Resources

Pharm/Tox Database. The NGVB hosts a database of Pharmacology and Toxicology studies performed to support FDA applications for gene therapy clinical trials (formerly the NGVL Pharm/Tox Database). Besides providing examples of how Pharm/Tox studies are designed, the NGVB will facilitate letters of cross-reference so that previously performed studies can be used by the FDA in considering your IND application. Summary data can be accessed by going to the Pharm/Tox Database. For full access to the database, obtain an NGVB account by clicking here and then contact the NGVB Coordinating Center to request access.

Pharmacology and Toxicology Tutorial. The NGVB has developed an educational tool for gene therapy investigators considering Pharm/Tox studies.

Pharmacology and Toxicology Archive. If you have performed Pharm/Tox studies submitted to the FDA and have material that must be archived under GLP conditions, the NGVB will store the samples at no cost to academic investigators. All we ask is that your study be summarized in the NGVB Pharm/Tox database. See Pharm/Tox Archive Request Form to request pharm/tox archive services.

Support Gene Therapy Research! Contribute your Reagent or Pharm/Tox Study to the NGVB. Contact The NGVB Coordinating Center for details.