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Toxicology Core

Unexpected or serious adverse events (SAEs) represent a potential danger in any clinical trial. To minimize the likelihood or seriousness of such events occurring during clinical research, toxicology studies are frequently required by the FDA before a trial is initiated. However, many grants do not provide support for such studies. In addition, toxicology data that are generated are usually considered to be proprietary and held within a Drug Master File, unavailable to other investigators. Consequently, toxicology studies are often repeated at great cost to both the research community and funding entities.

Toxicology Centers are funded through this cooperative agreement in order to generate and share toxicology data relevant to particular gene vectors. The Toxicology Core will be responsible for conducting animal and in vitro toxicology studies that the FDA determines are needed before a particular clinical gene transfer trial can begin. The Toxicology Core obtains, collates, analyses and stores the data generated. The data will be transmitted in the appropriate format both to the investigator for subsequent transmission to the FDA and regulatory agencies as needed.

Mission

Toxicology Centers generate and share toxicology data relevant to particular gene vectors. The Toxicology Center is responsible for conducting animal and in vitro toxicology studies that the FDA determines are needed before a particular clinical gene transfer trial can begin.

The Toxicology Center obtains, collates, analyses and stores the data generated. That data is transmitted in the appropriate format both to the investigator for subsequent transmission to the FDA and to the NGVL Coordinating Center for inclusion in the Toxicology Master File.

Personnel

  • Kirsten Erger – Technician

Assays

  • Real-time PCR
  • Serum Chemistries
  • Complete Blood Count (CBC)
  • ELISAs
  • Pathology

Publications

View a list of publications, abstracts, and presentations from members of the Toxicology Core.

Testimonials

See what others are saying about the Toxicology Core

Affiliates and Other Resources